ID

4502

Description

The purpose of this Phase 2 clinical research study is to examine the safety of an experimental gene transfer agent, Ad2/HIF-1α/VP16, and its ability to stimulate the growth of new blood vessels from existing blood vessels (a process called angiogenesis) in an attempt to improve the flow of blood in the legs of patients with peripheral arterial disease (PAD). Specifically, this study will enroll patients with severe intermittent claudication (IC) which is the stage of PAD in which a patient's walking ability is severely limited, causing pain in the legs upon exercise due to inadequate blood flow to the muscles of the lower limbs.

Keywords

  1. 12/9/13 12/9/13 - Martin Dugas
Uploaded on

December 9, 2013

DOI

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License

Creative Commons BY-NC 3.0 Legacy

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Eligibility NCT00117650 # Intermittent Claudication

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion criteria
Description

Inclusion criteria

No Healthy Volunteers
Description

Healthy Volunteers

Data type

boolean

Alias
UMLS CUI
C1708335
Males and females 40 to 80 years of age, inclusive.
Description

InclusionCriterion_1

Data type

boolean

Alias
UMLS CUI
C0079399
SNOMED CT 2010_0731
263495000
LNC
MTHU002975
UMLS CUI
C0001779
SNOMED CT 2010_0731
424144002
LNC
MTHU010047
Clinical diagnosis of PAD, secondary to atherosclerosis, in both lower limbs, confirmed by objective evidence: An ankle-brachial index (ABI) of ≤ 0.90 at rest in at least 1 lower limb (Note: The index limb must be ≤ 0.90 at rest.); The ABI after exercise must be reduced by ≥ 20% from the ABI at rest in the index leg (the most symptomatic leg during the treadmill testing). The post-exercise ABI will also be performed on the other leg if the resting ABI > 0.90. A patient may be eligible for the study with a resting ABI in the non-index limb > 0.90 if: a. The post-exercise ABI in the non-index leg is also reduced by greater than or equal to 20% OR; b. A medically significant stenosis (defined as ≥ 50%) of a femoropopliteal or infrapopliteal artery is present, as documented via an imaging study (such as MR, conventional angiography, duplex ultrasound, or CT); If the ABI cannot be measured in either leg (due to non-compressible arteries), then a toe-brachial index (TBI) of ≤ 0.70 may be used in its place to confirm PAD.
Description

InclusionCriterion_2

Data type

boolean

Alias
UMLS CUI
C1704436
MDR
067825
SNOMED CT 2010_0731
399957001
UMLS CUI
C0004153
ICD10CM
I70
ICD9CM
440
MDR
10003601
SNOMED CT 2010_0731
38716007
UMLS CUI
C0023216
LNC
MTHU011970
SNOMED CT 2010_0731
61685007
UMLS CUI
C1328319
MDR
10062762
UMLS CUI
C0087110
MDR
10044555
UMLS CUI
C2721556
MDR
10069344
UMLS CUI
C0447110
SNOMED CT 2010_0731
244336000
UMLS CUI
C1261287
UMLS CUI
C1881134
LNC
MTHU029412
UMLS CUI
C2116889
Symptoms of severe intermittent claudication (IC) in at least 1 lower limb persisting for ≥ 6 months
Description

InclusionCriterion_3

Data type

boolean

Alias
UMLS CUI
C0021775
ICD10CM
I73.9
MDR
10022562
SNOMED CT 2010_0731
63491006
UMLS CUI
C0023216
LNC
MTHU011970
SNOMED CT 2010_0731
61685007
Patients with a peak walking time (PWT) of 1 to 12 minutes (inclusive) using the standardized exercise treadmill test at each of the 2 consecutive treadmill tests performed at least a week apart during the Screening period.
Description

InclusionCriterion_4

Data type

boolean

Alias
UMLS CUI
C0430506
SNOMED CT 2010_0731
302761001
UMLS CUI
C0087110
MDR
10044555
During Screening, patients must demonstrate consistency of PWTs between 2 standardized exercise treadmill tests (Walk 1 and Walk 2) performed at least 1 week apart.
Description

InclusionCriterion_5

Data type

boolean

Alias
UMLS CUI
C0430506
SNOMED CT 2010_0731
302761001
UMLS CUI
C0087110
MDR
10044555
Consistency of the PWT between the 2 visits is achieved if the difference between PWT at Walk 1 and Walk 2 is ≤ 25% of the higher of the 2 PWTs ([higher PWT - lower PWT]/higher PWT).
Description

InclusionCriterion_6

Data type

boolean

Alias
UMLS CUI
C0430506
SNOMED CT 2010_0731
302761001
If the difference between PWT at Walk 1 and Walk 2 is > 25% of the higher of the 2 PWTs, a third treadmill test (Walk 3) may be performed at the discretion of the Principal Investigator between 7 and 14 days following Walk 2. The variability in PWT warranting the performance of Walk 3 must be secondary to circumstances that may contribute to the observed variation (e.g., prior exertion, inconsistent timing, ingestion of a meal within 4 hours, etc). To qualify for the study, the difference between PWT of either Walk 1 or Walk 2 as compared with Walk 3 must be ≤ 25% of the higher of the 2 PWTs ([higher PWT - lower PWT]/higher PWT). The decision whether Walk 1 or Walk 2 will be used for comparison with Walk 3 will be made prospectively and reviewed with the Sponsor.
Description

InclusionCriterion_7

Data type

boolean

Alias
UMLS CUI
C0430506
SNOMED CT 2010_0731
302761001
UMLS CUI
CL102947
An acceptable mean PWT must be achieved within 4 weeks of treatment administration.
Description

InclusionCriterion_8

Data type

boolean

Alias
UMLS CUI
C0430506
SNOMED CT 2010_0731
302761001
Patients have been considered for other potential treatment options including exercise rehabilitation, smoking cessation, and pharmacological therapy prior to Enrollment.
Description

InclusionCriterion_9

Data type

boolean

Alias
UMLS CUI
C1631603
SNOMED CT 2010_0731
419733004
UMLS CUI
C0683525
UMLS CUI
C1516879
Claudication severity, concomitant medications for the treatment of CAD, PAD, and IC, smoking status and exercise habits should be clinically stable for 3 months prior to Enrollment.
Description

InclusionCriterion_10

Data type

boolean

Alias
UMLS CUI
C0021775
ICD10CM
I73.9
MDR
10022562
SNOMED CT 2010_0731
63491006
UMLS CUI
C0439793
SNOMED CT 2010_0731
246112005
UMLS CUI
C2826666
UMLS CUI
C0010068
ICD10CM
I25.1
MDR
10068617
SNOMED CT 2010_0731
53741008
UMLS CUI
C1704436
MDR
067825
SNOMED CT 2010_0731
399957001
UMLS CUI
C1519386
UMLS CUI
C0015259
MDR
10015634
SNOMED CT 2010_0731
183301007
UMLS CUI
C0205360
LNC
MTHU015276
SNOMED CT 2010_0731
58158008
UMLS CUI
C1516879
Patients who are committed to following the protocol requirements as evidenced by written informed consent.
Description

InclusionCriterion_11

Data type

boolean

Alias
UMLS CUI
C0021430
Exclusion criteria
Description

Exclusion criteria

Patients with either current or any history of Critical Limb Ischemia (CLI; that is, patients classified as Rutherford Category 4 [ischemic rest pain], Rutherford Category 5 [non-healing ischemic ulcers and minor tissue loss], or Rutherford Category 6 [non-healing ischemic ulcers and major tissue loss]).
Description

ExclusionCriterion_1

Data type

boolean

Alias
UMLS CUI
C1142264
MDR
10058072
Patients in whom arterial insufficiency in the lower extremity is the result of acute limb ischemia or an immunological or inflammatory non-atherosclerotic disorder (eg, thromboangiitis obliterans [Buerger's Disease]) and systemic sclerosis [both limited and diffuse forms]).
Description

ExclusionCriterion_2

Data type

boolean

Alias
UMLS CUI
C0340565
SNOMED CT 2010_0731
233961000
UMLS CUI
C0021053
ICD10CM
D89.9
ICD9CM
279
MDR
10021425
SNOMED CT 2010_0731
41266007
UMLS CUI
C1290884
SNOMED CT 2010_0731
128139000
UMLS CUI
C0040021
ICD10CM
I73.1
ICD9CM
443.1
MDR
10043540
SNOMED CT 2010_0731
52403007
UMLS CUI
C0036421
ICD10CM
M34.0
ICD9CM
710.1
MDR
10042953
SNOMED CT 2010_0731
89155008
A PAD-specific surgical revascularization procedure within 6 months of enrollment or a PAD-specific percutaneous procedure within 3 months of enrollment, or patients likely to require a PAD-specific revascularization procedure within 6 months after Enrollment.
Description

ExclusionCriterion_3

Data type

boolean

Alias
UMLS CUI
C0472670
SNOMED CT 2010_0731
233505002
UMLS CUI
C1516879
Patients with aortoiliac disease that limits inflow in either leg: a. Patients with concomitant aortoiliac disease (i.e., patients with a significant component of inflow disease in the distal aorta, common or external iliac, or proximal common femoral artery) as assessed by an imaging modality (e.g., segmental limb pressures and waveform analysis, duplex ultrasound scanning, magnetic resonance angiography, or radio-contrast arteriogram) performed within 1 year prior to Enrollment. If subject has had a bypass after the imaging study, then documentation of graft patency is required within 6 months prior to Enrollment; b. If it is suspected at Screening that a patient has aortoiliac disease based on vascular examination, an imaging modality (e.g., segmental limb pressures and waveform analysis, duplex ultrasound scanning, magnetic resonance angiography, or radio-contrast arteriogram) must be performed to rule it out if there is not one available within the times specified above. If there is no suspicion of aortoiliac disease in the Principal Investigator's judgment, an imaging test at Screening is not required for study purposes.
Description

ExclusionCriterion_4

Data type

boolean

Alias
UMLS CUI
C0729733
SNOMED CT 2010_0731
233956002
UMLS CUI
C1881134
LNC
MTHU029412
UMLS CUI
C1516879
UMLS CUI
C0741847
SNOMED CT 2010_0731
88834003
UMLS CUI
CL102947
Patients in whom walking impairment due to pain in the index leg is the result of these nonatherosclerotic comorbid conditions: venous claudication, chronic compartment syndrome, peripheral nerve pain (e.g., severe peripheral neuropathy), pseudoclaudication caused by spinal cord compression, or acute limb ischemia which, in the Principal Investigator's judgment are severe enough to confound the assessment of the patient's IC.
Description

ExclusionCriterion_5

Data type

boolean

Alias
UMLS CUI
C0311395
MDR
10058726
SNOMED CT 2010_0731
16973004
UMLS CUI
C0521535
SNOMED CT 2010_0731
95443002
UMLS CUI
C0436020
SNOMED CT 2010_0731
212385001
UMLS CUI
C0031117
ICD10CM
G64
ICD9CM
350-359.99
MDR
10029331
SNOMED CT 2010_0731
302226006
UMLS CUI
C0410647
MDR
10041539
SNOMED CT 2010_0731
240219003
UMLS CUI
C0340565
SNOMED CT 2010_0731
233961000
UMLS CUI
CL102947
Conditions other than IC of significant severity that could confound PWT on the standardized exercise treadmill test causing premature or inconsistent termination of exercise (e.g., angina pectoris, heart failure [New York Heart Association {NYHA} Classes III and IV], respiratory disease [e.g., chronic obstructive pulmonary disease], orthopedic disease, neurological disorders, rheumatologic disorders [e.g., severe degenerative joint diseases], dyspnea, fatigue, prior lower limb amputation, including amputations proximal to the metatarsal or phalangeal joints).
Description

ExclusionCriterion_6

Data type

boolean

Alias
UMLS CUI
C0021775
ICD10CM
I73.9
MDR
10022562
SNOMED CT 2010_0731
63491006
UMLS CUI
C0430506
SNOMED CT 2010_0731
302761001
UMLS CUI
C0087110
MDR
10044555
UMLS CUI
C0002962
CTCAE
E10110
ICD10CM
I20
ICD9CM
413
MDR
10002383
SNOMED CT 2010_0731
194828000
UMLS CUI
C0018801
CTCAE
E10124
ICD10CM
I50
ICD9CM
428
MDR
10007554
SNOMED CT 2010_0731
84114007
UMLS CUI
C1319795
MDR
10064081
SNOMED CT 2010_0731
420913000
UMLS CUI
C1319796
MDR
10064082
SNOMED CT 2010_0731
422293003
UMLS CUI
C0035204
ICD10CM
J00-J99
ICD9CM
460-519.99
MDR
10038683
SNOMED CT 2010_0731
50043002
UMLS CUI
C0263661
MDR
10031173
SNOMED CT 2010_0731
88230002
UMLS CUI
C0027765
ICD10CM
G00-G99
ICD9CM
349.9
MDR
10029202
SNOMED CT 2010_0731
118940003
UMLS CUI
C0009326
MDR
10009903
SNOMED CT 2010_0731
81573002
UMLS CUI
C0029408
ICD10CM
M15-M19
ICD9CM
715.9
MDR
10031161
SNOMED CT 2010_0731
225655006
UMLS CUI
C0013404
CTCAE
E13368
ICD10CM
R06.0
ICD9CM
786.05
MDR
10013968
SNOMED CT 2010_0731
267036007
UMLS CUI
C0015672
CTCAE
E11098
ICD10CM
R53.83
LNC
MTHU013358
MDR
10016256
SNOMED CT 2010_0731
84229001
UMLS CUI
C0337308
ICD9CM
84.1
MDR
10024124
SNOMED CT 2010_0731
397117006
UMLS CUI
C0188494
ICD9CM
84.13
SNOMED CT 2010_0731
397218006
UMLS CUI
C0408870
SNOMED CT 2010_0731
239591008
Presence or history of cancer within 5 years of enrollment or not current with recommended screening guidelines for colorectal, lung, prostate, breast, cervical, and uterine cancers, with the exception of low grade and fully resolved non-melanoma skin malignancy.
Description

ExclusionCriterion_7

Data type

boolean

Alias
UMLS CUI
C0006826
ICD10CM
C00-C96
ICD9CM
199
LNC
MTHU010328
MDR
10028997
SNOMED CT 2010_0731
363346000
UMLS CUI
C1516879
UMLS CUI
C0199230
SNOMED CT 2010_0731
15886004
UMLS CUI
C0281185
UMLS CUI
C0281477
SNOMED CT 2010_0731
275981009
UMLS CUI
C0281186
UMLS CUI
C1536442
UMLS CUI
C0281187
UMLS CUI
C0677799
UMLS CUI
C0037286
MDR
10029098
SNOMED CT 2010_0731
126488004
UMLS CUI
C1334989
Patients with a well-defined clinical or genetic disorder predisposing to malignancy should be excluded (e.g., von Hippel Lindau, familial polyposis coli, BRCA1, BRCA2, etc).
Description

ExclusionCriterion_8

Data type

boolean

Alias
UMLS CUI
C0032927
UMLS CUI
C0019562
ICD10CM
Q85.8
MDR
10047716
SNOMED CT 2010_0731
46659004
UMLS CUI
C0032580
MDR
10056981
SNOMED CT 2010_0731
72900001
UMLS CUI
C0376571
UMLS CUI
C0598034
Patients with a well-defined clinical or genetic disorder predisposing to malignancy should be excluded (e.g., von Hippel Lindau, familial polyposis coli, BRCA1, BRCA2, etc).
Description

ExclusionCriterion_8

Data type

boolean

Alias
UMLS CUI
C0032927
UMLS CUI
C0019562
ICD10CM
Q85.8
MDR
10047716
SNOMED CT 2010_0731
46659004
UMLS CUI
C0032580
MDR
10056981
SNOMED CT 2010_0731
72900001
UMLS CUI
C0376571
UMLS CUI
C0598034
Patients with baseline funduscopic evidence of active proliferative diabetic retinopathy, preproliferative diabetic retinopathy, or wet AMD AND/OR Patients with a history of treatment for active proliferative diabetic retinopathy or wet AMD within 5 years of enrollment.
Description

ExclusionCriterion_9

Data type

boolean

Alias
UMLS CUI
C0029090
ICD9CM
16.21
MDR
10017519
SNOMED CT 2010_0731
53524009
UMLS CUI
C0011884
ICD9CM
362.0
MDR
10012689
SNOMED CT 2010_0731
4855003
UMLS CUI
C0271084
ICD10CM
H35.32
ICD9CM
362.52
MDR
10015902
SNOMED CT 2010_0731
414173003
UMLS CUI
C1516879
Diabetes type 1 (juvenile onset)
Description

ExclusionCriterion_10

Data type

boolean

Alias
UMLS CUI
C0011854
ICD10CM
E10
LNC
MTHU020217
MDR
10067584
SNOMED CT 2010_0731
46635009
Poorly controlled type 2 diabetes (ie, HbA1C >10%) at Screening
Description

ExclusionCriterion_11

Data type

boolean

Alias
UMLS CUI
C0011860
ICD10CM
E11
MDR
10067585
SNOMED CT 2010_0731
44054006
UMLS CUI
C0366781
LNC
4548-4
Active hepatitis defined as clinically significant increase in liver enzymes (ie, 3 times the ULN) or other current infectious disease
Description

ExclusionCriterion_12

Data type

boolean

Alias
UMLS CUI
C0019158
ICD10CM
K75.9
ICD9CM
573.3
MDR
10019717
SNOMED CT 2010_0731
128241005
UMLS CUI
C1860080
UMLS CUI
C1290884
SNOMED CT 2010_0731
128139000
Patients with symptoms of respiratory infection at time of Screening and/or randomization period and/or patients who have been on systemic or oral antibiotics for active infection within 2 weeks of study drug administration.
Description

ExclusionCriterion_13

Data type

boolean

Alias
UMLS CUI
C0035243
LNC
MTHU026191
MDR
10024970
SNOMED CT 2010_0731
275498002
UMLS CUI
C0338237
MDR
10067768
SNOMED CT 2010_0731
281789004
UMLS CUI
C1290884
SNOMED CT 2010_0731
128139000
Patients with clinically significant abnormal hematology (eg, hematocrit < 30%, white blood cell count > 14,000), blood chemistry, renal, hepatic, or other laboratory parameters that could be the result of an underlying malignancy or systemic infection (e.g., serum creatinine ≥ 2.5 mg/dL), as judged by the investigator.
Description

ExclusionCriterion_14

Data type

boolean

Alias
UMLS CUI
C1112712
MDR
10057755
UMLS CUI
C0366777
LNC
4544-3
UMLS CUI
C0484430
LNC
6690-2
UMLS CUI
C1332129
UMLS CUI
C0438215
MDR
10023547
SNOMED CT 2010_0731
309158009
UMLS CUI
C0006826
ICD10CM
C00-C96
ICD9CM
199
LNC
MTHU010328
MDR
10028997
SNOMED CT 2010_0731
363346000
UMLS CUI
C0243026
ICD9CM
995.91
MDR
10040047
SNOMED CT 2010_0731
91302008
UMLS CUI
C0151578
CTCAE
E12137
MDR
10011368
UMLS CUI
CL102947
Patients with the following comorbidities who may not be healthy enough to successfully complete all protocol requirements or in whom results may be particularly difficult to assess: Concurrent severe congestive heart failure (NYHA Classes III and IV); Life-threatening ventricular arrhythmias, unstable angina (characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged duration), and/or myocardial infarction within 4 weeks before enrollment; Coronary artery bypass grafting or percutaneous coronary intervention within 3 months before enrollment; A renal and/or carotid revascularization procedure within 1 month of enrollment; Transient ischemic attack within 3 months before enrollment; Deep vein thrombosis within 3 months before enrollment; Severe chronic obstructive pulmonary disease (room air arterial PO2 < 60 mmHg or PCO2 > 50 mmHg, or abnormal pulmonary function tests (FEV1 < 1.2 L/sec); Thrombocytopenia (defined as platelet count < 100,000/mm3); Undergoing hemodialysis; Patients with immunocompromised conditions, organ transplant recipients and/or need for immunosuppressive therapy; Neurological dementia (i.e., Alzheimer's Disease); Hemorrhagic stroke
Description

ExclusionCriterion_15

Data type

boolean

Alias
UMLS CUI
C0018801
CTCAE
E10124
ICD10CM
I50
ICD9CM
428
MDR
10007554
SNOMED CT 2010_0731
84114007
UMLS CUI
C1319795
MDR
10064081
SNOMED CT 2010_0731
420913000
UMLS CUI
C1319796
MDR
10064082
SNOMED CT 2010_0731
422293003
UMLS CUI
C0085612
MDR
10047281
SNOMED CT 2010_0731
44103008
UMLS CUI
C0002965
ICD10CM
I20.0
ICD9CM
411.1
MDR
10002388
SNOMED CT 2010_0731
4557003
UMLS CUI
C0027051
CTCAE
E10152
ICD10CM
I21-I22
MDR
10028596
SNOMED CT 2010_0731
22298006
UMLS CUI
C0010055
ICD9CM
36.10
MDR
10011077
SNOMED CT 2010_0731
232717009
UMLS CUI
C1532338
MDR
10065608
SNOMED CT 2010_0731
415070008
UMLS CUI
C0581603
SNOMED CT 2010_0731
297183000
UMLS CUI
C0035065
LNC
MTHU016747
SNOMED CT 2010_0731
2841007
UMLS CUI
C0007272
LNC
MTHU011911
SNOMED CT 2010_0731
69105007
UMLS CUI
C0007787
CTCAE
E12834
ICD10CM
G45.9
LNC
MTHU020810
MDR
10044390
SNOMED CT 2010_0731
266257000
UMLS CUI
C0149871
ICD10CM
I82.40
LNC
MTHU020788
MDR
10051055
SNOMED CT 2010_0731
128053003
UMLS CUI
C0024117
ICD10CM
J44.9
MDR
10009033
SNOMED CT 2010_0731
13645005
UMLS CUI
C0202155
MDR
10035766
SNOMED CT 2010_0731
25579001
UMLS CUI
C0201931
MDR
10034180
SNOMED CT 2010_0731
25284008
UMLS CUI
C0476405
ICD10CM
R94.2
ICD9CM
794.2
MDR
10061602
SNOMED CT 2010_0731
165019004
UMLS CUI
CL414841
UMLS CUI
C0040034
CTCAE
E12207
ICD10CM
D69.6
ICD9CM
287.5
MDR
10043554
SNOMED CT 2010_0731
415116008
UMLS CUI
C0362994
LNC
777-3
UMLS CUI
C0019004
ICD9CM
39.95
MDR
10018875
SNOMED CT 2010_0731
302497006
UMLS CUI
C0085393
SNOMED CT 2010_0731
370388006
UMLS CUI
C0376387
UMLS CUI
C0021079
SNOMED CT 2010_0731
86553008
UMLS CUI
C0497327
ICD10CM
F03
ICD9CM
290
MDR
10012267
SNOMED CT 2010_0731
52448006
UMLS CUI
C0002395
ICD10CM
G30
ICD9CM
331.0
MDR
10001896
SNOMED CT 2010_0731
26929004
UMLS CUI
C0553692
MDR
10019016
SNOMED CT 2010_0731
230706003
UMLS CUI
C1516879
Patients with a known allergy to the vehicle, placebo control, or any other medications or imaging agents required for participation in this study.
Description

ExclusionCriterion_16

Data type

boolean

Alias
UMLS CUI
C0013182
HL7V3.0
DALG
ICD10CM
T88.7
MDR
10013700
SNOMED CT 2010_0731
416098002
UMLS CUI
C0570562
MDR
10066973
SNOMED CT 2010_0731
293637006
Fertile women who are pregnant (as confirmed by a serum pregnancy test at the Screening Visit and a urine pregnancy test at Day 0 prior to study drug administration), nursing, or using either no or an inadequate form of contraception.
Description

ExclusionCriterion_17

Data type

boolean

Alias
UMLS CUI
C0427780
MDR
10036574
SNOMED CT 2010_0731
250425007
UMLS CUI
C0006147
MDR
10006247
SNOMED CT 2010_0731
169741004
UMLS CUI
C0700589
LNC
MTHU024530
MDR
10010808
SNOMED CT 2010_0731
13197004
Fertile men and women who are not willing to use barrier-type contraception for at least 90 days post-treatment.
Description

ExclusionCriterion_18

Data type

boolean

Alias
UMLS CUI
C0004764
SNOMED CT 2010_0731
225370004
Patients with a recent history of alcoholism or drug abuse, or severe emotional, behavioral or psychiatric problems, who may not be able to adequately comply with the requirements of the study.
Description

ExclusionCriterion_19

Data type

boolean

Alias
UMLS CUI
C0001973
ICD10CM
F10.2
ICD9CM
303
MDR
10001639
SNOMED CT 2010_0731
7200002
UMLS CUI
C0004936
ICD10CM
F01-F99
ICD9CM
290-319.99
MDR
10061284
SNOMED CT 2010_0731
74732009
UMLS CUI
C0013146
ICD9CM
305
LNC
MTHU019367
MDR
10013654
SNOMED CT 2010_0731
26416006
Patients receiving experimental medications or participating in another study using an experimental drug or experimental procedure within 30 days of enrollment into this study.
Description

ExclusionCriterion_20

Data type

boolean

Alias
UMLS CUI
C0304229
SNOMED CT 2010_0731
902003
UMLS CUI
C1516879
Patients previously enrolled in a prior angiogenic gene therapy clinical study, unless patient was a known placebo patient.
Description

ExclusionCriterion_21

Data type

boolean

Alias
UMLS CUI
C1514459
UMLS CUI
C0032042
Medical Concepts
Description

Medical Concepts

Healthy Subject
Description

Healthy Subject

Data type

string

Alias
UMLS CUI
C1708335
Gender
Description

Gender

Data type

string

Alias
UMLS CUI
C0079399
SNOMED CT 2010_0731
263495000
LNC
MTHU002975
Age
Description

Age

Data type

string

Alias
UMLS CUI
C0001779
SNOMED CT 2010_0731
424144002
LNC
MTHU010047
Peripheral Arterial Diseases
Description

Peripheral Arterial Diseases

Data type

string

Alias
UMLS CUI
C1704436
MDR
067825
SNOMED CT 2010_0731
399957001
Atherosclerosis
Description

Atherosclerosis

Data type

string

Alias
UMLS CUI
C0004153
ICD10CM
I70
ICD9CM
440
MDR
10003601
SNOMED CT 2010_0731
38716007
Lower Extremity
Description

Lower Extremity

Data type

string

Alias
UMLS CUI
C0023216
LNC
MTHU011970
SNOMED CT 2010_0731
61685007
Ankle-Brachial Index
Description

Ankle-Brachial Index

Data type

string

Alias
UMLS CUI
C1328319
MDR
10062762
Treadmill Tests
Description

Treadmill Tests

Data type

string

Alias
UMLS CUI
C0087110
MDR
10044555
Femoropopliteal stenosis
Description

Femoropopliteal stenosis

Data type

string

Alias
UMLS CUI
C2721556
MDR
10069344
Crural artery
Description

Crural artery

Data type

string

Alias
UMLS CUI
C0447110
SNOMED CT 2010_0731
244336000
Stenosis
Description

Stenosis

Data type

string

Alias
UMLS CUI
C1261287
Image Study
Description

Image Study

Data type

string

Alias
UMLS CUI
C1881134
LNC
MTHU029412
Toe-Brachial Index
Description

Toe-Brachial Index

Data type

string

Alias
UMLS CUI
C2116889
Intermittent Claudication
Description

Intermittent Claudication

Data type

string

Alias
UMLS CUI
C0021775
ICD10CM
I73.9
MDR
10022562
SNOMED CT 2010_0731
63491006
Walking exercise test
Description

Walking exercise test

Data type

string

Alias
UMLS CUI
C0430506
SNOMED CT 2010_0731
302761001
Investigator
Description

Investigator

Data type

string

Alias
UMLS CUI
CL102947
Patient notified
Description

Patient notified

Data type

string

Alias
UMLS CUI
C1631603
SNOMED CT 2010_0731
419733004
treatment options
Description

treatment options

Data type

string

Alias
UMLS CUI
C0683525
Enrollment
Description

Enrollment

Data type

string

Alias
UMLS CUI
C1516879
Severity
Description

Severity

Data type

string

Alias
UMLS CUI
C0439793
SNOMED CT 2010_0731
246112005
Concomitant Medication Ongoing
Description

Concomitant Medication Ongoing

Data type

string

Alias
UMLS CUI
C2826666
Coronary heart disease
Description

Coronary heart disease

Data type

string

Alias
UMLS CUI
C0010068
ICD10CM
I25.1
MDR
10068617
SNOMED CT 2010_0731
53741008
Smoking Status
Description

Smoking Status

Data type

string

Alias
UMLS CUI
C1519386
Exercise
Description

Exercise

Data type

string

Alias
UMLS CUI
C0015259
MDR
10015634
SNOMED CT 2010_0731
183301007
Stable status
Description

Stable status

Data type

string

Alias
UMLS CUI
C0205360
LNC
MTHU015276
SNOMED CT 2010_0731
58158008
Informed Consent
Description

Informed Consent

Data type

string

Alias
UMLS CUI
C0021430
Critical limb ischaemia
Description

Critical limb ischaemia

Data type

string

Alias
UMLS CUI
C1142264
MDR
10058072
Lower limb ischemia
Description

Lower limb ischemia

Data type

string

Alias
UMLS CUI
C0340565
SNOMED CT 2010_0731
233961000
Immune System Disorder
Description

Immune System Disorder

Data type

string

Alias
UMLS CUI
C0021053
ICD10CM
D89.9
ICD9CM
279
MDR
10021425
SNOMED CT 2010_0731
41266007
Inflammatory Disorder
Description

Inflammatory Disorder

Data type

string

Alias
UMLS CUI
C1290884
SNOMED CT 2010_0731
128139000
Thromboangiitis Obliterans
Description

Thromboangiitis Obliterans

Data type

string

Alias
UMLS CUI
C0040021
ICD10CM
I73.1
ICD9CM
443.1
MDR
10043540
SNOMED CT 2010_0731
52403007
Systemic Scleroderma
Description

Systemic Scleroderma

Data type

string

Alias
UMLS CUI
C0036421
ICD10CM
M34.0
ICD9CM
710.1
MDR
10042953
SNOMED CT 2010_0731
89155008
Revascularization of lower limb
Description

Revascularization of lower limb

Data type

string

Alias
UMLS CUI
C0472670
SNOMED CT 2010_0731
233505002
Aortoiliac atherosclerosis
Description

Aortoiliac atherosclerosis

Data type

string

Alias
UMLS CUI
C0729733
SNOMED CT 2010_0731
233956002
Bypass
Description

Bypass

Data type

string

Alias
UMLS CUI
C0741847
SNOMED CT 2010_0731
88834003
Lameness
Description

Lameness

Data type

string

Alias
UMLS CUI
C0311395
MDR
10058726
SNOMED CT 2010_0731
16973004
Venous intermittent claudication
Description

Venous intermittent claudication

Data type

string

Alias
UMLS CUI
C0521535
SNOMED CT 2010_0731
95443002
Compartment syndrome of lower limb
Description

Compartment syndrome of lower limb

Data type

string

Alias
UMLS CUI
C0436020
SNOMED CT 2010_0731
212385001
Peripheral Neuropathy
Description

Peripheral Neuropathy

Data type

string

Alias
UMLS CUI
C0031117
ICD10CM
G64
ICD9CM
350-359.99
MDR
10029331
SNOMED CT 2010_0731
302226006
Spinal claudication
Description

Spinal claudication

Data type

string

Alias
UMLS CUI
C0410647
MDR
10041539
SNOMED CT 2010_0731
240219003
Angina Pectoris
Description

Angina Pectoris

Data type

string

Alias
UMLS CUI
C0002962
CTCAE
E10110
ICD10CM
I20
ICD9CM
413
MDR
10002383
SNOMED CT 2010_0731
194828000
Heart failure
Description

Heart failure

Data type

string

Alias
UMLS CUI
C0018801
CTCAE
E10124
ICD10CM
I50
ICD9CM
428
MDR
10007554
SNOMED CT 2010_0731
84114007
New York Heart Association Class III
Description

New York Heart Association Class III

Data type

string

Alias
UMLS CUI
C1319795
MDR
10064081
SNOMED CT 2010_0731
420913000
New York Heart Association Class IV
Description

New York Heart Association Class IV

Data type

string

Alias
UMLS CUI
C1319796
MDR
10064082
SNOMED CT 2010_0731
422293003
Respiration Disorders
Description

Respiration Disorders

Data type

string

Alias
UMLS CUI
C0035204
ICD10CM
J00-J99
ICD9CM
460-519.99
MDR
10038683
SNOMED CT 2010_0731
50043002
Disorder of skeletal system
Description

Disorder of skeletal system

Data type

string

Alias
UMLS CUI
C0263661
MDR
10031173
SNOMED CT 2010_0731
88230002
nervous system disorder
Description

nervous system disorder

Data type

string

Alias
UMLS CUI
C0027765
ICD10CM
G00-G99
ICD9CM
349.9
MDR
10029202
SNOMED CT 2010_0731
118940003
Collagen Diseases
Description

Collagen Diseases

Data type

string

Alias
UMLS CUI
C0009326
MDR
10009903
SNOMED CT 2010_0731
81573002
Degenerative polyarthritis
Description

Degenerative polyarthritis

Data type

string

Alias
UMLS CUI
C0029408
ICD10CM
M15-M19
ICD9CM
715.9
MDR
10031161
SNOMED CT 2010_0731
225655006
Dyspnea
Description

Dyspnea

Data type

string

Alias
UMLS CUI
C0013404
CTCAE
E13368
ICD10CM
R06.0
ICD9CM
786.05
MDR
10013968
SNOMED CT 2010_0731
267036007
Fatigue
Description

Fatigue

Data type

string

Alias
UMLS CUI
C0015672
CTCAE
E11098
ICD10CM
R53.83
LNC
MTHU013358
MDR
10016256
SNOMED CT 2010_0731
84229001
Amputation of lower limb
Description

Amputation of lower limb

Data type

string

Alias
UMLS CUI
C0337308
ICD9CM
84.1
MDR
10024124
SNOMED CT 2010_0731
397117006
Amputation of ankle (procedure)
Description

Amputation of ankle (procedure)

Data type

string

Alias
UMLS CUI
C0188494
ICD9CM
84.13
SNOMED CT 2010_0731
397218006
Midfoot amputation
Description

Midfoot amputation

Data type

string

Alias
UMLS CUI
C0408870
SNOMED CT 2010_0731
239591008
Malignant Neoplasms
Description

Malignant Neoplasms

Data type

string

Alias
UMLS CUI
C0006826
ICD10CM
C00-C96
ICD9CM
199
LNC
MTHU010328
MDR
10028997
SNOMED CT 2010_0731
363346000
Screening for cancer
Description

Screening for cancer

Data type

string

Alias
UMLS CUI
C0199230
SNOMED CT 2010_0731
15886004
Screening for Colorectal Cancer
Description

Screening for Colorectal Cancer

Data type

string

Alias
UMLS CUI
C0281185
Screening for Lung Cancer
Description

Screening for Lung Cancer

Data type

string

Alias
UMLS CUI
C0281477
SNOMED CT 2010_0731
275981009
Screening for Prostate Cancer
Description

Screening for Prostate Cancer

Data type

string

Alias
UMLS CUI
C0281186
Breast Cancer Screening
Description

Breast Cancer Screening

Data type

string

Alias
UMLS CUI
C1536442
Cervical Cancer Screening
Description

Cervical Cancer Screening

Data type

string

Alias
UMLS CUI
C0281187
Screening for Endometrial Cancer
Description

Screening for Endometrial Cancer

Data type

string

Alias
UMLS CUI
C0677799
Skin Neoplasms
Description

Skin Neoplasms

Data type

string

Alias
UMLS CUI
C0037286
MDR
10029098
SNOMED CT 2010_0731
126488004
Non-Melanomatous Lesion
Description

Non-Melanomatous Lesion

Data type

string

Alias
UMLS CUI
C1334989
Precancerous Conditions
Description

Precancerous Conditions

Data type

string

Alias
UMLS CUI
C0032927
Von Hippel-Lindau Syndrome
Description

Von Hippel-Lindau Syndrome

Data type

string

Alias
UMLS CUI
C0019562
ICD10CM
Q85.8
MDR
10047716
SNOMED CT 2010_0731
46659004
Adenomatous Polyposis Coli
Description

Adenomatous Polyposis Coli

Data type

string

Alias
UMLS CUI
C0032580
MDR
10056981
SNOMED CT 2010_0731
72900001
BRCA1 gene
Description

BRCA1 gene

Data type

string

Alias
UMLS CUI
C0376571
BRCA2 gene
Description

BRCA2 gene

Data type

string

Alias
UMLS CUI
C0598034
Ophthalmoscopy
Description

Ophthalmoscopy

Data type

string

Alias
UMLS CUI
C0029090
ICD9CM
16.21
MDR
10017519
SNOMED CT 2010_0731
53524009
Diabetic Retinopathy
Description

Diabetic Retinopathy

Data type

string

Alias
UMLS CUI
C0011884
ICD9CM
362.0
MDR
10012689
SNOMED CT 2010_0731
4855003
Exudative age-related macular degeneration
Description

Exudative age-related macular degeneration

Data type

string

Alias
UMLS CUI
C0271084
ICD10CM
H35.32
ICD9CM
362.52
MDR
10015902
SNOMED CT 2010_0731
414173003
Diabetes Mellitus, Insulin-Dependent
Description

Diabetes Mellitus, Insulin-Dependent

Data type

string

Alias
UMLS CUI
C0011854
ICD10CM
E10
LNC
MTHU020217
MDR
10067584
SNOMED CT 2010_0731
46635009
Diabetes Mellitus, Non-Insulin-Dependent
Description

Diabetes Mellitus, Non-Insulin-Dependent

Data type

string

Alias
UMLS CUI
C0011860
ICD10CM
E11
MDR
10067585
SNOMED CT 2010_0731
44054006
Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn
Description

Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn

Data type

string

Alias
UMLS CUI
C0366781
LNC
4548-4
Hepatitis
Description

Hepatitis

Data type

string

Alias
UMLS CUI
C0019158
ICD10CM
K75.9
ICD9CM
573.3
MDR
10019717
SNOMED CT 2010_0731
128241005
Increased liver enzymes
Description

Increased liver enzymes

Data type

string

Alias
UMLS CUI
C1860080
Respiratory Tract Infections
Description

Respiratory Tract Infections

Data type

string

Alias
UMLS CUI
C0035243
LNC
MTHU026191
MDR
10024970
SNOMED CT 2010_0731
275498002
Antibiotic Therapy
Description

Antibiotic Therapy

Data type

string

Alias
UMLS CUI
C0338237
MDR
10067768
SNOMED CT 2010_0731
281789004
Abnormal Hematology Test Result
Description

Abnormal Hematology Test Result

Data type

string

Alias
UMLS CUI
C1112712
MDR
10057755
Hematocrit:VFr:Pt:Bld:Qn:Automated count
Description

Hematocrit:VFr:Pt:Bld:Qn:Automated count

Data type

string

Alias
UMLS CUI
C0366777
LNC
4544-3
Leukocytes:NCnc:Pt:Bld:Qn:Automated count
Description

Leukocytes:NCnc:Pt:Bld:Qn:Automated count

Data type

string

Alias
UMLS CUI
C0484430
LNC
6690-2
Abnormal Blood Chemistry and Hematology Test Result
Description

Abnormal Blood Chemistry and Hematology Test Result

Data type

string

Alias
UMLS CUI
C1332129
Abnormal Laboratory Test Result
Description

Abnormal Laboratory Test Result

Data type

string

Alias
UMLS CUI
C0438215
MDR
10023547
SNOMED CT 2010_0731
309158009
Increased Creatinine
Description

Increased Creatinine

Data type

string

Alias
UMLS CUI
C0151578
CTCAE
E12137
MDR
10011368
Ventricular arrhythmia
Description

Ventricular arrhythmia

Data type

string

Alias
UMLS CUI
C0085612
MDR
10047281
SNOMED CT 2010_0731
44103008
Angina, Unstable
Description

Angina, Unstable

Data type

string

Alias
UMLS CUI
C0002965
ICD10CM
I20.0
ICD9CM
411.1
MDR
10002388
SNOMED CT 2010_0731
4557003
Myocardial Infarction
Description

Myocardial Infarction

Data type

string

Alias
UMLS CUI
C0027051
CTCAE
E10152
ICD10CM
I21-I22
MDR
10028596
SNOMED CT 2010_0731
22298006
Coronary Artery Bypass Surgery
Description

Coronary Artery Bypass Surgery

Data type

string

Alias
UMLS CUI
C0010055
ICD9CM
36.10
MDR
10011077
SNOMED CT 2010_0731
232717009
Percutaneous coronary intervention
Description

Percutaneous coronary intervention

Data type

string

Alias
UMLS CUI
C1532338
MDR
10065608
SNOMED CT 2010_0731
415070008
Revascularization - action
Description

Revascularization - action

Data type

string

Alias
UMLS CUI
C0581603
SNOMED CT 2010_0731
297183000
Structure of renal artery
Description

Structure of renal artery

Data type

string

Alias
UMLS CUI
C0035065
LNC
MTHU016747
SNOMED CT 2010_0731
2841007
Carotid Arteries
Description

Carotid Arteries

Data type

string

Alias
UMLS CUI
C0007272
LNC
MTHU011911
SNOMED CT 2010_0731
69105007
Transient Ischemic Attack
Description

Transient Ischemic Attack

Data type

string

Alias
UMLS CUI
C0007787
CTCAE
E12834
ICD10CM
G45.9
LNC
MTHU020810
MDR
10044390
SNOMED CT 2010_0731
266257000
Deep Vein Thrombosis
Description

Deep Vein Thrombosis

Data type

string

Alias
UMLS CUI
C0149871
ICD10CM
I82.40
LNC
MTHU020788
MDR
10051055
SNOMED CT 2010_0731
128053003
Chronic Obstructive Airway Disease
Description

Chronic Obstructive Airway Disease

Data type

string

Alias
UMLS CUI
C0024117
ICD10CM
J44.9
MDR
10009033
SNOMED CT 2010_0731
13645005
Partial Pressure of Oxygen Measurement
Description

Partial Pressure of Oxygen Measurement

Data type

string

Alias
UMLS CUI
C0202155
MDR
10035766
SNOMED CT 2010_0731
25579001
Partial Pressure of Carbon Dioxide Measurement
Description

Partial Pressure of Carbon Dioxide Measurement

Data type

string

Alias
UMLS CUI
C0201931
MDR
10034180
SNOMED CT 2010_0731
25284008
Lung function testing abnormal
Description

Lung function testing abnormal

Data type

string

Alias
UMLS CUI
C0476405
ICD10CM
R94.2
ICD9CM
794.2
MDR
10061602
SNOMED CT 2010_0731
165019004
Forced Expiratory Volume in 1 Second
Description

Forced Expiratory Volume in 1 Second

Data type

string

Alias
UMLS CUI
CL414841
Thrombocytopenia
Description

Thrombocytopenia

Data type

string

Alias
UMLS CUI
C0040034
CTCAE
E12207
ICD10CM
D69.6
ICD9CM
287.5
MDR
10043554
SNOMED CT 2010_0731
415116008
Platelet # Bld Auto
Description

Platelet # Bld Auto

Data type

string

Alias
UMLS CUI
C0362994
LNC
777-3
Hemodialysis
Description

Hemodialysis

Data type

string

Alias
UMLS CUI
C0019004
ICD9CM
39.95
MDR
10018875
SNOMED CT 2010_0731
302497006
Immunocompromised
Description

Immunocompromised

Data type

string

Alias
UMLS CUI
C0085393
SNOMED CT 2010_0731
370388006
Transplant Recipients
Description

Transplant Recipients

Data type

string

Alias
UMLS CUI
C0376387
Therapeutic immunosuppression
Description

Therapeutic immunosuppression

Data type

string

Alias
UMLS CUI
C0021079
SNOMED CT 2010_0731
86553008
Dementia
Description

Dementia

Data type

string

Alias
UMLS CUI
C0497327
ICD10CM
F03
ICD9CM
290
MDR
10012267
SNOMED CT 2010_0731
52448006
Alzheimer's Disease
Description

Alzheimer's Disease

Data type

string

Alias
UMLS CUI
C0002395
ICD10CM
G30
ICD9CM
331.0
MDR
10001896
SNOMED CT 2010_0731
26929004
Brain hemorrhage
Description

Brain hemorrhage

Data type

string

Alias
UMLS CUI
C0553692
MDR
10019016
SNOMED CT 2010_0731
230706003
Drug Allergy
Description

Drug Allergy

Data type

string

Alias
UMLS CUI
C0013182
HL7V3.0
DALG
ICD10CM
T88.7
MDR
10013700
SNOMED CT 2010_0731
416098002
Contrast media allergy
Description

Contrast media allergy

Data type

string

Alias
UMLS CUI
C0570562
MDR
10066973
SNOMED CT 2010_0731
293637006
Negative Pregnancy Test
Description

Negative Pregnancy Test

Data type

string

Alias
UMLS CUI
C0427780
MDR
10036574
SNOMED CT 2010_0731
250425007
Breastfeeding
Description

Breastfeeding

Data type

string

Alias
UMLS CUI
C0006147
MDR
10006247
SNOMED CT 2010_0731
169741004
Contraceptive methods
Description

Contraceptive methods

Data type

string

Alias
UMLS CUI
C0700589
LNC
MTHU024530
MDR
10010808
SNOMED CT 2010_0731
13197004
Contraception, Barrier
Description

Contraception, Barrier

Data type

string

Alias
UMLS CUI
C0004764
SNOMED CT 2010_0731
225370004
Alcoholic Intoxication, Chronic
Description

Alcoholic Intoxication, Chronic

Data type

string

Alias
UMLS CUI
C0001973
ICD10CM
F10.2
ICD9CM
303
MDR
10001639
SNOMED CT 2010_0731
7200002
Mental disorders
Description

Mental disorders

Data type

string

Alias
UMLS CUI
C0004936
ICD10CM
F01-F99
ICD9CM
290-319.99
MDR
10061284
SNOMED CT 2010_0731
74732009
Drug abuse
Description

Drug abuse

Data type

string

Alias
UMLS CUI
C0013146
ICD9CM
305
LNC
MTHU019367
MDR
10013654
SNOMED CT 2010_0731
26416006
Experimental drug
Description

Experimental drug

Data type

string

Alias
UMLS CUI
C0304229
SNOMED CT 2010_0731
902003
Prior Gene Therapy
Description

Prior Gene Therapy

Data type

string

Alias
UMLS CUI
C1514459
Placebos
Description

Placebos

Data type

string

Alias
UMLS CUI
C0032042

Similar models

Eligibility

  1. StudyEvent: Eligibility
    1. Eligibility
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Inclusion criteria
Healthy Volunteers
Item
No Healthy Volunteers
boolean
C1708335 (UMLS CUI)
InclusionCriterion_1
Item
Males and females 40 to 80 years of age, inclusive.
boolean
C0079399 (UMLS CUI)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LNC)
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
InclusionCriterion_2
Item
Clinical diagnosis of PAD, secondary to atherosclerosis, in both lower limbs, confirmed by objective evidence: An ankle-brachial index (ABI) of ≤ 0.90 at rest in at least 1 lower limb (Note: The index limb must be ≤ 0.90 at rest.); The ABI after exercise must be reduced by ≥ 20% from the ABI at rest in the index leg (the most symptomatic leg during the treadmill testing). The post-exercise ABI will also be performed on the other leg if the resting ABI > 0.90. A patient may be eligible for the study with a resting ABI in the non-index limb > 0.90 if: a. The post-exercise ABI in the non-index leg is also reduced by greater than or equal to 20% OR; b. A medically significant stenosis (defined as ≥ 50%) of a femoropopliteal or infrapopliteal artery is present, as documented via an imaging study (such as MR, conventional angiography, duplex ultrasound, or CT); If the ABI cannot be measured in either leg (due to non-compressible arteries), then a toe-brachial index (TBI) of ≤ 0.70 may be used in its place to confirm PAD.
boolean
C1704436 (UMLS CUI)
067825 (MDR)
399957001 (SNOMED CT 2010_0731)
C0004153 (UMLS CUI)
I70 (ICD10CM)
440 (ICD9CM)
10003601 (MDR)
38716007 (SNOMED CT 2010_0731)
C0023216 (UMLS CUI)
MTHU011970 (LNC)
61685007 (SNOMED CT 2010_0731)
C1328319 (UMLS CUI)
10062762 (MDR)
C0087110 (UMLS CUI)
10044555 (MDR)
C2721556 (UMLS CUI)
10069344 (MDR)
C0447110 (UMLS CUI)
244336000 (SNOMED CT 2010_0731)
C1261287 (UMLS CUI)
C1881134 (UMLS CUI)
MTHU029412 (LNC)
C2116889 (UMLS CUI)
InclusionCriterion_3
Item
Symptoms of severe intermittent claudication (IC) in at least 1 lower limb persisting for ≥ 6 months
boolean
C0021775 (UMLS CUI)
I73.9 (ICD10CM)
10022562 (MDR)
63491006 (SNOMED CT 2010_0731)
C0023216 (UMLS CUI)
MTHU011970 (LNC)
61685007 (SNOMED CT 2010_0731)
InclusionCriterion_4
Item
Patients with a peak walking time (PWT) of 1 to 12 minutes (inclusive) using the standardized exercise treadmill test at each of the 2 consecutive treadmill tests performed at least a week apart during the Screening period.
boolean
C0430506 (UMLS CUI)
302761001 (SNOMED CT 2010_0731)
C0087110 (UMLS CUI)
10044555 (MDR)
InclusionCriterion_5
Item
During Screening, patients must demonstrate consistency of PWTs between 2 standardized exercise treadmill tests (Walk 1 and Walk 2) performed at least 1 week apart.
boolean
C0430506 (UMLS CUI)
302761001 (SNOMED CT 2010_0731)
C0087110 (UMLS CUI)
10044555 (MDR)
InclusionCriterion_6
Item
Consistency of the PWT between the 2 visits is achieved if the difference between PWT at Walk 1 and Walk 2 is ≤ 25% of the higher of the 2 PWTs ([higher PWT - lower PWT]/higher PWT).
boolean
C0430506 (UMLS CUI)
302761001 (SNOMED CT 2010_0731)
InclusionCriterion_7
Item
If the difference between PWT at Walk 1 and Walk 2 is > 25% of the higher of the 2 PWTs, a third treadmill test (Walk 3) may be performed at the discretion of the Principal Investigator between 7 and 14 days following Walk 2. The variability in PWT warranting the performance of Walk 3 must be secondary to circumstances that may contribute to the observed variation (e.g., prior exertion, inconsistent timing, ingestion of a meal within 4 hours, etc). To qualify for the study, the difference between PWT of either Walk 1 or Walk 2 as compared with Walk 3 must be ≤ 25% of the higher of the 2 PWTs ([higher PWT - lower PWT]/higher PWT). The decision whether Walk 1 or Walk 2 will be used for comparison with Walk 3 will be made prospectively and reviewed with the Sponsor.
boolean
C0430506 (UMLS CUI)
302761001 (SNOMED CT 2010_0731)
CL102947 (UMLS CUI)
InclusionCriterion_8
Item
An acceptable mean PWT must be achieved within 4 weeks of treatment administration.
boolean
C0430506 (UMLS CUI)
302761001 (SNOMED CT 2010_0731)
InclusionCriterion_9
Item
Patients have been considered for other potential treatment options including exercise rehabilitation, smoking cessation, and pharmacological therapy prior to Enrollment.
boolean
C1631603 (UMLS CUI)
419733004 (SNOMED CT 2010_0731)
C0683525 (UMLS CUI)
C1516879 (UMLS CUI)
InclusionCriterion_10
Item
Claudication severity, concomitant medications for the treatment of CAD, PAD, and IC, smoking status and exercise habits should be clinically stable for 3 months prior to Enrollment.
boolean
C0021775 (UMLS CUI)
I73.9 (ICD10CM)
10022562 (MDR)
63491006 (SNOMED CT 2010_0731)
C0439793 (UMLS CUI)
246112005 (SNOMED CT 2010_0731)
C2826666 (UMLS CUI)
C0010068 (UMLS CUI)
I25.1 (ICD10CM)
10068617 (MDR)
53741008 (SNOMED CT 2010_0731)
C1704436 (UMLS CUI)
067825 (MDR)
399957001 (SNOMED CT 2010_0731)
C1519386 (UMLS CUI)
C0015259 (UMLS CUI)
10015634 (MDR)
183301007 (SNOMED CT 2010_0731)
C0205360 (UMLS CUI)
MTHU015276 (LNC)
58158008 (SNOMED CT 2010_0731)
C1516879 (UMLS CUI)
InclusionCriterion_11
Item
Patients who are committed to following the protocol requirements as evidenced by written informed consent.
boolean
C0021430 (UMLS CUI)
Item Group
Exclusion criteria
ExclusionCriterion_1
Item
Patients with either current or any history of Critical Limb Ischemia (CLI; that is, patients classified as Rutherford Category 4 [ischemic rest pain], Rutherford Category 5 [non-healing ischemic ulcers and minor tissue loss], or Rutherford Category 6 [non-healing ischemic ulcers and major tissue loss]).
boolean
C1142264 (UMLS CUI)
10058072 (MDR)
ExclusionCriterion_2
Item
Patients in whom arterial insufficiency in the lower extremity is the result of acute limb ischemia or an immunological or inflammatory non-atherosclerotic disorder (eg, thromboangiitis obliterans [Buerger's Disease]) and systemic sclerosis [both limited and diffuse forms]).
boolean
C0340565 (UMLS CUI)
233961000 (SNOMED CT 2010_0731)
C0021053 (UMLS CUI)
D89.9 (ICD10CM)
279 (ICD9CM)
10021425 (MDR)
41266007 (SNOMED CT 2010_0731)
C1290884 (UMLS CUI)
128139000 (SNOMED CT 2010_0731)
C0040021 (UMLS CUI)
I73.1 (ICD10CM)
443.1 (ICD9CM)
10043540 (MDR)
52403007 (SNOMED CT 2010_0731)
C0036421 (UMLS CUI)
M34.0 (ICD10CM)
710.1 (ICD9CM)
10042953 (MDR)
89155008 (SNOMED CT 2010_0731)
ExclusionCriterion_3
Item
A PAD-specific surgical revascularization procedure within 6 months of enrollment or a PAD-specific percutaneous procedure within 3 months of enrollment, or patients likely to require a PAD-specific revascularization procedure within 6 months after Enrollment.
boolean
C0472670 (UMLS CUI)
233505002 (SNOMED CT 2010_0731)
C1516879 (UMLS CUI)
ExclusionCriterion_4
Item
Patients with aortoiliac disease that limits inflow in either leg: a. Patients with concomitant aortoiliac disease (i.e., patients with a significant component of inflow disease in the distal aorta, common or external iliac, or proximal common femoral artery) as assessed by an imaging modality (e.g., segmental limb pressures and waveform analysis, duplex ultrasound scanning, magnetic resonance angiography, or radio-contrast arteriogram) performed within 1 year prior to Enrollment. If subject has had a bypass after the imaging study, then documentation of graft patency is required within 6 months prior to Enrollment; b. If it is suspected at Screening that a patient has aortoiliac disease based on vascular examination, an imaging modality (e.g., segmental limb pressures and waveform analysis, duplex ultrasound scanning, magnetic resonance angiography, or radio-contrast arteriogram) must be performed to rule it out if there is not one available within the times specified above. If there is no suspicion of aortoiliac disease in the Principal Investigator's judgment, an imaging test at Screening is not required for study purposes.
boolean
C0729733 (UMLS CUI)
233956002 (SNOMED CT 2010_0731)
C1881134 (UMLS CUI)
MTHU029412 (LNC)
C1516879 (UMLS CUI)
C0741847 (UMLS CUI)
88834003 (SNOMED CT 2010_0731)
CL102947 (UMLS CUI)
ExclusionCriterion_5
Item
Patients in whom walking impairment due to pain in the index leg is the result of these nonatherosclerotic comorbid conditions: venous claudication, chronic compartment syndrome, peripheral nerve pain (e.g., severe peripheral neuropathy), pseudoclaudication caused by spinal cord compression, or acute limb ischemia which, in the Principal Investigator's judgment are severe enough to confound the assessment of the patient's IC.
boolean
C0311395 (UMLS CUI)
10058726 (MDR)
16973004 (SNOMED CT 2010_0731)
C0521535 (UMLS CUI)
95443002 (SNOMED CT 2010_0731)
C0436020 (UMLS CUI)
212385001 (SNOMED CT 2010_0731)
C0031117 (UMLS CUI)
G64 (ICD10CM)
350-359.99 (ICD9CM)
10029331 (MDR)
302226006 (SNOMED CT 2010_0731)
C0410647 (UMLS CUI)
10041539 (MDR)
240219003 (SNOMED CT 2010_0731)
C0340565 (UMLS CUI)
233961000 (SNOMED CT 2010_0731)
CL102947 (UMLS CUI)
ExclusionCriterion_6
Item
Conditions other than IC of significant severity that could confound PWT on the standardized exercise treadmill test causing premature or inconsistent termination of exercise (e.g., angina pectoris, heart failure [New York Heart Association {NYHA} Classes III and IV], respiratory disease [e.g., chronic obstructive pulmonary disease], orthopedic disease, neurological disorders, rheumatologic disorders [e.g., severe degenerative joint diseases], dyspnea, fatigue, prior lower limb amputation, including amputations proximal to the metatarsal or phalangeal joints).
boolean
C0021775 (UMLS CUI)
I73.9 (ICD10CM)
10022562 (MDR)
63491006 (SNOMED CT 2010_0731)
C0430506 (UMLS CUI)
302761001 (SNOMED CT 2010_0731)
C0087110 (UMLS CUI)
10044555 (MDR)
C0002962 (UMLS CUI)
E10110 (CTCAE)
I20 (ICD10CM)
413 (ICD9CM)
10002383 (MDR)
194828000 (SNOMED CT 2010_0731)
C0018801 (UMLS CUI)
E10124 (CTCAE)
I50 (ICD10CM)
428 (ICD9CM)
10007554 (MDR)
84114007 (SNOMED CT 2010_0731)
C1319795 (UMLS CUI)
10064081 (MDR)
420913000 (SNOMED CT 2010_0731)
C1319796 (UMLS CUI)
10064082 (MDR)
422293003 (SNOMED CT 2010_0731)
C0035204 (UMLS CUI)
J00-J99 (ICD10CM)
460-519.99 (ICD9CM)
10038683 (MDR)
50043002 (SNOMED CT 2010_0731)
C0263661 (UMLS CUI)
10031173 (MDR)
88230002 (SNOMED CT 2010_0731)
C0027765 (UMLS CUI)
G00-G99 (ICD10CM)
349.9 (ICD9CM)
10029202 (MDR)
118940003 (SNOMED CT 2010_0731)
C0009326 (UMLS CUI)
10009903 (MDR)
81573002 (SNOMED CT 2010_0731)
C0029408 (UMLS CUI)
M15-M19 (ICD10CM)
715.9 (ICD9CM)
10031161 (MDR)
225655006 (SNOMED CT 2010_0731)
C0013404 (UMLS CUI)
E13368 (CTCAE)
R06.0 (ICD10CM)
786.05 (ICD9CM)
10013968 (MDR)
267036007 (SNOMED CT 2010_0731)
C0015672 (UMLS CUI)
E11098 (CTCAE)
R53.83 (ICD10CM)
MTHU013358 (LNC)
10016256 (MDR)
84229001 (SNOMED CT 2010_0731)
C0337308 (UMLS CUI)
84.1 (ICD9CM)
10024124 (MDR)
397117006 (SNOMED CT 2010_0731)
C0188494 (UMLS CUI)
84.13 (ICD9CM)
397218006 (SNOMED CT 2010_0731)
C0408870 (UMLS CUI)
239591008 (SNOMED CT 2010_0731)
ExclusionCriterion_7
Item
Presence or history of cancer within 5 years of enrollment or not current with recommended screening guidelines for colorectal, lung, prostate, breast, cervical, and uterine cancers, with the exception of low grade and fully resolved non-melanoma skin malignancy.
boolean
C0006826 (UMLS CUI)
C00-C96 (ICD10CM)
199 (ICD9CM)
MTHU010328 (LNC)
10028997 (MDR)
363346000 (SNOMED CT 2010_0731)
C1516879 (UMLS CUI)
C0199230 (UMLS CUI)
15886004 (SNOMED CT 2010_0731)
C0281185 (UMLS CUI)
C0281477 (UMLS CUI)
275981009 (SNOMED CT 2010_0731)
C0281186 (UMLS CUI)
C1536442 (UMLS CUI)
C0281187 (UMLS CUI)
C0677799 (UMLS CUI)
C0037286 (UMLS CUI)
10029098 (MDR)
126488004 (SNOMED CT 2010_0731)
C1334989 (UMLS CUI)
ExclusionCriterion_8
Item
Patients with a well-defined clinical or genetic disorder predisposing to malignancy should be excluded (e.g., von Hippel Lindau, familial polyposis coli, BRCA1, BRCA2, etc).
boolean
C0032927 (UMLS CUI)
C0019562 (UMLS CUI)
Q85.8 (ICD10CM)
10047716 (MDR)
46659004 (SNOMED CT 2010_0731)
C0032580 (UMLS CUI)
10056981 (MDR)
72900001 (SNOMED CT 2010_0731)
C0376571 (UMLS CUI)
C0598034 (UMLS CUI)
ExclusionCriterion_8
Item
Patients with a well-defined clinical or genetic disorder predisposing to malignancy should be excluded (e.g., von Hippel Lindau, familial polyposis coli, BRCA1, BRCA2, etc).
boolean
C0032927 (UMLS CUI)
C0019562 (UMLS CUI)
Q85.8 (ICD10CM)
10047716 (MDR)
46659004 (SNOMED CT 2010_0731)
C0032580 (UMLS CUI)
10056981 (MDR)
72900001 (SNOMED CT 2010_0731)
C0376571 (UMLS CUI)
C0598034 (UMLS CUI)
ExclusionCriterion_9
Item
Patients with baseline funduscopic evidence of active proliferative diabetic retinopathy, preproliferative diabetic retinopathy, or wet AMD AND/OR Patients with a history of treatment for active proliferative diabetic retinopathy or wet AMD within 5 years of enrollment.
boolean
C0029090 (UMLS CUI)
16.21 (ICD9CM)
10017519 (MDR)
53524009 (SNOMED CT 2010_0731)
C0011884 (UMLS CUI)
362.0 (ICD9CM)
10012689 (MDR)
4855003 (SNOMED CT 2010_0731)
C0271084 (UMLS CUI)
H35.32 (ICD10CM)
362.52 (ICD9CM)
10015902 (MDR)
414173003 (SNOMED CT 2010_0731)
C1516879 (UMLS CUI)
ExclusionCriterion_10
Item
Diabetes type 1 (juvenile onset)
boolean
C0011854 (UMLS CUI)
E10 (ICD10CM)
MTHU020217 (LNC)
10067584 (MDR)
46635009 (SNOMED CT 2010_0731)
ExclusionCriterion_11
Item
Poorly controlled type 2 diabetes (ie, HbA1C >10%) at Screening
boolean
C0011860 (UMLS CUI)
E11 (ICD10CM)
10067585 (MDR)
44054006 (SNOMED CT 2010_0731)
C0366781 (UMLS CUI)
4548-4 (LNC)
ExclusionCriterion_12
Item
Active hepatitis defined as clinically significant increase in liver enzymes (ie, 3 times the ULN) or other current infectious disease
boolean
C0019158 (UMLS CUI)
K75.9 (ICD10CM)
573.3 (ICD9CM)
10019717 (MDR)
128241005 (SNOMED CT 2010_0731)
C1860080 (UMLS CUI)
C1290884 (UMLS CUI)
128139000 (SNOMED CT 2010_0731)
ExclusionCriterion_13
Item
Patients with symptoms of respiratory infection at time of Screening and/or randomization period and/or patients who have been on systemic or oral antibiotics for active infection within 2 weeks of study drug administration.
boolean
C0035243 (UMLS CUI)
MTHU026191 (LNC)
10024970 (MDR)
275498002 (SNOMED CT 2010_0731)
C0338237 (UMLS CUI)
10067768 (MDR)
281789004 (SNOMED CT 2010_0731)
C1290884 (UMLS CUI)
128139000 (SNOMED CT 2010_0731)
ExclusionCriterion_14
Item
Patients with clinically significant abnormal hematology (eg, hematocrit < 30%, white blood cell count > 14,000), blood chemistry, renal, hepatic, or other laboratory parameters that could be the result of an underlying malignancy or systemic infection (e.g., serum creatinine ≥ 2.5 mg/dL), as judged by the investigator.
boolean
C1112712 (UMLS CUI)
10057755 (MDR)
C0366777 (UMLS CUI)
4544-3 (LNC)
C0484430 (UMLS CUI)
6690-2 (LNC)
C1332129 (UMLS CUI)
C0438215 (UMLS CUI)
10023547 (MDR)
309158009 (SNOMED CT 2010_0731)
C0006826 (UMLS CUI)
C00-C96 (ICD10CM)
199 (ICD9CM)
MTHU010328 (LNC)
10028997 (MDR)
363346000 (SNOMED CT 2010_0731)
C0243026 (UMLS CUI)
995.91 (ICD9CM)
10040047 (MDR)
91302008 (SNOMED CT 2010_0731)
C0151578 (UMLS CUI)
E12137 (CTCAE)
10011368 (MDR)
CL102947 (UMLS CUI)
ExclusionCriterion_15
Item
Patients with the following comorbidities who may not be healthy enough to successfully complete all protocol requirements or in whom results may be particularly difficult to assess: Concurrent severe congestive heart failure (NYHA Classes III and IV); Life-threatening ventricular arrhythmias, unstable angina (characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged duration), and/or myocardial infarction within 4 weeks before enrollment; Coronary artery bypass grafting or percutaneous coronary intervention within 3 months before enrollment; A renal and/or carotid revascularization procedure within 1 month of enrollment; Transient ischemic attack within 3 months before enrollment; Deep vein thrombosis within 3 months before enrollment; Severe chronic obstructive pulmonary disease (room air arterial PO2 < 60 mmHg or PCO2 > 50 mmHg, or abnormal pulmonary function tests (FEV1 < 1.2 L/sec); Thrombocytopenia (defined as platelet count < 100,000/mm3); Undergoing hemodialysis; Patients with immunocompromised conditions, organ transplant recipients and/or need for immunosuppressive therapy; Neurological dementia (i.e., Alzheimer's Disease); Hemorrhagic stroke
boolean
C0018801 (UMLS CUI)
E10124 (CTCAE)
I50 (ICD10CM)
428 (ICD9CM)
10007554 (MDR)
84114007 (SNOMED CT 2010_0731)
C1319795 (UMLS CUI)
10064081 (MDR)
420913000 (SNOMED CT 2010_0731)
C1319796 (UMLS CUI)
10064082 (MDR)
422293003 (SNOMED CT 2010_0731)
C0085612 (UMLS CUI)
10047281 (MDR)
44103008 (SNOMED CT 2010_0731)
C0002965 (UMLS CUI)
I20.0 (ICD10CM)
411.1 (ICD9CM)
10002388 (MDR)
4557003 (SNOMED CT 2010_0731)
C0027051 (UMLS CUI)
E10152 (CTCAE)
I21-I22 (ICD10CM)
10028596 (MDR)
22298006 (SNOMED CT 2010_0731)
C0010055 (UMLS CUI)
36.10 (ICD9CM)
10011077 (MDR)
232717009 (SNOMED CT 2010_0731)
C1532338 (UMLS CUI)
10065608 (MDR)
415070008 (SNOMED CT 2010_0731)
C0581603 (UMLS CUI)
297183000 (SNOMED CT 2010_0731)
C0035065 (UMLS CUI)
MTHU016747 (LNC)
2841007 (SNOMED CT 2010_0731)
C0007272 (UMLS CUI)
MTHU011911 (LNC)
69105007 (SNOMED CT 2010_0731)
C0007787 (UMLS CUI)
E12834 (CTCAE)
G45.9 (ICD10CM)
MTHU020810 (LNC)
10044390 (MDR)
266257000 (SNOMED CT 2010_0731)
C0149871 (UMLS CUI)
I82.40 (ICD10CM)
MTHU020788 (LNC)
10051055 (MDR)
128053003 (SNOMED CT 2010_0731)
C0024117 (UMLS CUI)
J44.9 (ICD10CM)
10009033 (MDR)
13645005 (SNOMED CT 2010_0731)
C0202155 (UMLS CUI)
10035766 (MDR)
25579001 (SNOMED CT 2010_0731)
C0201931 (UMLS CUI)
10034180 (MDR)
25284008 (SNOMED CT 2010_0731)
C0476405 (UMLS CUI)
R94.2 (ICD10CM)
794.2 (ICD9CM)
10061602 (MDR)
165019004 (SNOMED CT 2010_0731)
CL414841 (UMLS CUI)
C0040034 (UMLS CUI)
E12207 (CTCAE)
D69.6 (ICD10CM)
287.5 (ICD9CM)
10043554 (MDR)
415116008 (SNOMED CT 2010_0731)
C0362994 (UMLS CUI)
777-3 (LNC)
C0019004 (UMLS CUI)
39.95 (ICD9CM)
10018875 (MDR)
302497006 (SNOMED CT 2010_0731)
C0085393 (UMLS CUI)
370388006 (SNOMED CT 2010_0731)
C0376387 (UMLS CUI)
C0021079 (UMLS CUI)
86553008 (SNOMED CT 2010_0731)
C0497327 (UMLS CUI)
F03 (ICD10CM)
290 (ICD9CM)
10012267 (MDR)
52448006 (SNOMED CT 2010_0731)
C0002395 (UMLS CUI)
G30 (ICD10CM)
331.0 (ICD9CM)
10001896 (MDR)
26929004 (SNOMED CT 2010_0731)
C0553692 (UMLS CUI)
10019016 (MDR)
230706003 (SNOMED CT 2010_0731)
C1516879 (UMLS CUI)
ExclusionCriterion_16
Item
Patients with a known allergy to the vehicle, placebo control, or any other medications or imaging agents required for participation in this study.
boolean
C0013182 (UMLS CUI)
DALG (HL7V3.0)
T88.7 (ICD10CM)
10013700 (MDR)
416098002 (SNOMED CT 2010_0731)
C0570562 (UMLS CUI)
10066973 (MDR)
293637006 (SNOMED CT 2010_0731)
ExclusionCriterion_17
Item
Fertile women who are pregnant (as confirmed by a serum pregnancy test at the Screening Visit and a urine pregnancy test at Day 0 prior to study drug administration), nursing, or using either no or an inadequate form of contraception.
boolean
C0427780 (UMLS CUI)
10036574 (MDR)
250425007 (SNOMED CT 2010_0731)
C0006147 (UMLS CUI)
10006247 (MDR)
169741004 (SNOMED CT 2010_0731)
C0700589 (UMLS CUI)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)
ExclusionCriterion_18
Item
Fertile men and women who are not willing to use barrier-type contraception for at least 90 days post-treatment.
boolean
C0004764 (UMLS CUI)
225370004 (SNOMED CT 2010_0731)
ExclusionCriterion_19
Item
Patients with a recent history of alcoholism or drug abuse, or severe emotional, behavioral or psychiatric problems, who may not be able to adequately comply with the requirements of the study.
boolean
C0001973 (UMLS CUI)
F10.2 (ICD10CM)
303 (ICD9CM)
10001639 (MDR)
7200002 (SNOMED CT 2010_0731)
C0004936 (UMLS CUI)
F01-F99 (ICD10CM)
290-319.99 (ICD9CM)
10061284 (MDR)
74732009 (SNOMED CT 2010_0731)
C0013146 (UMLS CUI)
305 (ICD9CM)
MTHU019367 (LNC)
10013654 (MDR)
26416006 (SNOMED CT 2010_0731)
ExclusionCriterion_20
Item
Patients receiving experimental medications or participating in another study using an experimental drug or experimental procedure within 30 days of enrollment into this study.
boolean
C0304229 (UMLS CUI)
902003 (SNOMED CT 2010_0731)
C1516879 (UMLS CUI)
ExclusionCriterion_21
Item
Patients previously enrolled in a prior angiogenic gene therapy clinical study, unless patient was a known placebo patient.
boolean
C1514459 (UMLS CUI)
C0032042 (UMLS CUI)
Item Group
Medical Concepts
Healthy Subject
Item
Healthy Subject
string
C1708335 (UMLS CUI)
Gender
Item
Gender
string
C0079399 (UMLS CUI)
263495000 (SNOMED CT 2010_0731)
MTHU002975 (LNC)
Age
Item
Age
string
C0001779 (UMLS CUI)
424144002 (SNOMED CT 2010_0731)
MTHU010047 (LNC)
Peripheral Arterial Diseases
Item
Peripheral Arterial Diseases
string
C1704436 (UMLS CUI)
067825 (MDR)
399957001 (SNOMED CT 2010_0731)
Atherosclerosis
Item
Atherosclerosis
string
C0004153 (UMLS CUI)
I70 (ICD10CM)
440 (ICD9CM)
10003601 (MDR)
38716007 (SNOMED CT 2010_0731)
Lower Extremity
Item
Lower Extremity
string
C0023216 (UMLS CUI)
MTHU011970 (LNC)
61685007 (SNOMED CT 2010_0731)
Ankle-Brachial Index
Item
Ankle-Brachial Index
string
C1328319 (UMLS CUI)
10062762 (MDR)
Treadmill Tests
Item
Treadmill Tests
string
C0087110 (UMLS CUI)
10044555 (MDR)
Femoropopliteal stenosis
Item
Femoropopliteal stenosis
string
C2721556 (UMLS CUI)
10069344 (MDR)
Crural artery
Item
Crural artery
string
C0447110 (UMLS CUI)
244336000 (SNOMED CT 2010_0731)
Stenosis
Item
Stenosis
string
C1261287 (UMLS CUI)
Image Study
Item
Image Study
string
C1881134 (UMLS CUI)
MTHU029412 (LNC)
Toe-Brachial Index
Item
Toe-Brachial Index
string
C2116889 (UMLS CUI)
Intermittent Claudication
Item
Intermittent Claudication
string
C0021775 (UMLS CUI)
I73.9 (ICD10CM)
10022562 (MDR)
63491006 (SNOMED CT 2010_0731)
Walking exercise test
Item
Walking exercise test
string
C0430506 (UMLS CUI)
302761001 (SNOMED CT 2010_0731)
Investigator
Item
Investigator
string
CL102947 (UMLS CUI)
Patient notified
Item
Patient notified
string
C1631603 (UMLS CUI)
419733004 (SNOMED CT 2010_0731)
treatment options
Item
treatment options
string
C0683525 (UMLS CUI)
Enrollment
Item
Enrollment
string
C1516879 (UMLS CUI)
Severity
Item
Severity
string
C0439793 (UMLS CUI)
246112005 (SNOMED CT 2010_0731)
Concomitant Medication Ongoing
Item
Concomitant Medication Ongoing
string
C2826666 (UMLS CUI)
Coronary heart disease
Item
Coronary heart disease
string
C0010068 (UMLS CUI)
I25.1 (ICD10CM)
10068617 (MDR)
53741008 (SNOMED CT 2010_0731)
Smoking Status
Item
Smoking Status
string
C1519386 (UMLS CUI)
Exercise
Item
Exercise
string
C0015259 (UMLS CUI)
10015634 (MDR)
183301007 (SNOMED CT 2010_0731)
Stable status
Item
Stable status
string
C0205360 (UMLS CUI)
MTHU015276 (LNC)
58158008 (SNOMED CT 2010_0731)
Informed Consent
Item
Informed Consent
string
C0021430 (UMLS CUI)
Critical limb ischaemia
Item
Critical limb ischaemia
string
C1142264 (UMLS CUI)
10058072 (MDR)
Lower limb ischemia
Item
Lower limb ischemia
string
C0340565 (UMLS CUI)
233961000 (SNOMED CT 2010_0731)
Immune System Disorder
Item
Immune System Disorder
string
C0021053 (UMLS CUI)
D89.9 (ICD10CM)
279 (ICD9CM)
10021425 (MDR)
41266007 (SNOMED CT 2010_0731)
Inflammatory Disorder
Item
Inflammatory Disorder
string
C1290884 (UMLS CUI)
128139000 (SNOMED CT 2010_0731)
Thromboangiitis Obliterans
Item
Thromboangiitis Obliterans
string
C0040021 (UMLS CUI)
I73.1 (ICD10CM)
443.1 (ICD9CM)
10043540 (MDR)
52403007 (SNOMED CT 2010_0731)
Systemic Scleroderma
Item
Systemic Scleroderma
string
C0036421 (UMLS CUI)
M34.0 (ICD10CM)
710.1 (ICD9CM)
10042953 (MDR)
89155008 (SNOMED CT 2010_0731)
Revascularization of lower limb
Item
Revascularization of lower limb
string
C0472670 (UMLS CUI)
233505002 (SNOMED CT 2010_0731)
Aortoiliac atherosclerosis
Item
Aortoiliac atherosclerosis
string
C0729733 (UMLS CUI)
233956002 (SNOMED CT 2010_0731)
Bypass
Item
Bypass
string
C0741847 (UMLS CUI)
88834003 (SNOMED CT 2010_0731)
Lameness
Item
Lameness
string
C0311395 (UMLS CUI)
10058726 (MDR)
16973004 (SNOMED CT 2010_0731)
Venous intermittent claudication
Item
Venous intermittent claudication
string
C0521535 (UMLS CUI)
95443002 (SNOMED CT 2010_0731)
Compartment syndrome of lower limb
Item
Compartment syndrome of lower limb
string
C0436020 (UMLS CUI)
212385001 (SNOMED CT 2010_0731)
Peripheral Neuropathy
Item
Peripheral Neuropathy
string
C0031117 (UMLS CUI)
G64 (ICD10CM)
350-359.99 (ICD9CM)
10029331 (MDR)
302226006 (SNOMED CT 2010_0731)
Spinal claudication
Item
Spinal claudication
string
C0410647 (UMLS CUI)
10041539 (MDR)
240219003 (SNOMED CT 2010_0731)
Angina Pectoris
Item
Angina Pectoris
string
C0002962 (UMLS CUI)
E10110 (CTCAE)
I20 (ICD10CM)
413 (ICD9CM)
10002383 (MDR)
194828000 (SNOMED CT 2010_0731)
Heart failure
Item
Heart failure
string
C0018801 (UMLS CUI)
E10124 (CTCAE)
I50 (ICD10CM)
428 (ICD9CM)
10007554 (MDR)
84114007 (SNOMED CT 2010_0731)
New York Heart Association Class III
Item
New York Heart Association Class III
string
C1319795 (UMLS CUI)
10064081 (MDR)
420913000 (SNOMED CT 2010_0731)
New York Heart Association Class IV
Item
New York Heart Association Class IV
string
C1319796 (UMLS CUI)
10064082 (MDR)
422293003 (SNOMED CT 2010_0731)
Respiration Disorders
Item
Respiration Disorders
string
C0035204 (UMLS CUI)
J00-J99 (ICD10CM)
460-519.99 (ICD9CM)
10038683 (MDR)
50043002 (SNOMED CT 2010_0731)
Disorder of skeletal system
Item
Disorder of skeletal system
string
C0263661 (UMLS CUI)
10031173 (MDR)
88230002 (SNOMED CT 2010_0731)
nervous system disorder
Item
nervous system disorder
string
C0027765 (UMLS CUI)
G00-G99 (ICD10CM)
349.9 (ICD9CM)
10029202 (MDR)
118940003 (SNOMED CT 2010_0731)
Collagen Diseases
Item
Collagen Diseases
string
C0009326 (UMLS CUI)
10009903 (MDR)
81573002 (SNOMED CT 2010_0731)
Degenerative polyarthritis
Item
Degenerative polyarthritis
string
C0029408 (UMLS CUI)
M15-M19 (ICD10CM)
715.9 (ICD9CM)
10031161 (MDR)
225655006 (SNOMED CT 2010_0731)
Dyspnea
Item
Dyspnea
string
C0013404 (UMLS CUI)
E13368 (CTCAE)
R06.0 (ICD10CM)
786.05 (ICD9CM)
10013968 (MDR)
267036007 (SNOMED CT 2010_0731)
Fatigue
Item
Fatigue
string
C0015672 (UMLS CUI)
E11098 (CTCAE)
R53.83 (ICD10CM)
MTHU013358 (LNC)
10016256 (MDR)
84229001 (SNOMED CT 2010_0731)
Amputation of lower limb
Item
Amputation of lower limb
string
C0337308 (UMLS CUI)
84.1 (ICD9CM)
10024124 (MDR)
397117006 (SNOMED CT 2010_0731)
Amputation of ankle (procedure)
Item
Amputation of ankle (procedure)
string
C0188494 (UMLS CUI)
84.13 (ICD9CM)
397218006 (SNOMED CT 2010_0731)
Midfoot amputation
Item
Midfoot amputation
string
C0408870 (UMLS CUI)
239591008 (SNOMED CT 2010_0731)
Malignant Neoplasms
Item
Malignant Neoplasms
string
C0006826 (UMLS CUI)
C00-C96 (ICD10CM)
199 (ICD9CM)
MTHU010328 (LNC)
10028997 (MDR)
363346000 (SNOMED CT 2010_0731)
Screening for cancer
Item
Screening for cancer
string
C0199230 (UMLS CUI)
15886004 (SNOMED CT 2010_0731)
Screening for Colorectal Cancer
Item
Screening for Colorectal Cancer
string
C0281185 (UMLS CUI)
Screening for Lung Cancer
Item
Screening for Lung Cancer
string
C0281477 (UMLS CUI)
275981009 (SNOMED CT 2010_0731)
Screening for Prostate Cancer
Item
Screening for Prostate Cancer
string
C0281186 (UMLS CUI)
Breast Cancer Screening
Item
Breast Cancer Screening
string
C1536442 (UMLS CUI)
Cervical Cancer Screening
Item
Cervical Cancer Screening
string
C0281187 (UMLS CUI)
Screening for Endometrial Cancer
Item
Screening for Endometrial Cancer
string
C0677799 (UMLS CUI)
Skin Neoplasms
Item
Skin Neoplasms
string
C0037286 (UMLS CUI)
10029098 (MDR)
126488004 (SNOMED CT 2010_0731)
Non-Melanomatous Lesion
Item
Non-Melanomatous Lesion
string
C1334989 (UMLS CUI)
Precancerous Conditions
Item
Precancerous Conditions
string
C0032927 (UMLS CUI)
Von Hippel-Lindau Syndrome
Item
Von Hippel-Lindau Syndrome
string
C0019562 (UMLS CUI)
Q85.8 (ICD10CM)
10047716 (MDR)
46659004 (SNOMED CT 2010_0731)
Adenomatous Polyposis Coli
Item
Adenomatous Polyposis Coli
string
C0032580 (UMLS CUI)
10056981 (MDR)
72900001 (SNOMED CT 2010_0731)
BRCA1 gene
Item
BRCA1 gene
string
C0376571 (UMLS CUI)
BRCA2 gene
Item
BRCA2 gene
string
C0598034 (UMLS CUI)
Ophthalmoscopy
Item
Ophthalmoscopy
string
C0029090 (UMLS CUI)
16.21 (ICD9CM)
10017519 (MDR)
53524009 (SNOMED CT 2010_0731)
Diabetic Retinopathy
Item
Diabetic Retinopathy
string
C0011884 (UMLS CUI)
362.0 (ICD9CM)
10012689 (MDR)
4855003 (SNOMED CT 2010_0731)
Exudative age-related macular degeneration
Item
Exudative age-related macular degeneration
string
C0271084 (UMLS CUI)
H35.32 (ICD10CM)
362.52 (ICD9CM)
10015902 (MDR)
414173003 (SNOMED CT 2010_0731)
Diabetes Mellitus, Insulin-Dependent
Item
Diabetes Mellitus, Insulin-Dependent
string
C0011854 (UMLS CUI)
E10 (ICD10CM)
MTHU020217 (LNC)
10067584 (MDR)
46635009 (SNOMED CT 2010_0731)
Diabetes Mellitus, Non-Insulin-Dependent
Item
Diabetes Mellitus, Non-Insulin-Dependent
string
C0011860 (UMLS CUI)
E11 (ICD10CM)
10067585 (MDR)
44054006 (SNOMED CT 2010_0731)
Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn
Item
Hemoglobin A1c/Hemoglobin.total:SFr:Pt:Bld:Qn
string
C0366781 (UMLS CUI)
4548-4 (LNC)
Hepatitis
Item
Hepatitis
string
C0019158 (UMLS CUI)
K75.9 (ICD10CM)
573.3 (ICD9CM)
10019717 (MDR)
128241005 (SNOMED CT 2010_0731)
Increased liver enzymes
Item
Increased liver enzymes
string
C1860080 (UMLS CUI)
Respiratory Tract Infections
Item
Respiratory Tract Infections
string
C0035243 (UMLS CUI)
MTHU026191 (LNC)
10024970 (MDR)
275498002 (SNOMED CT 2010_0731)
Antibiotic Therapy
Item
Antibiotic Therapy
string
C0338237 (UMLS CUI)
10067768 (MDR)
281789004 (SNOMED CT 2010_0731)
Abnormal Hematology Test Result
Item
Abnormal Hematology Test Result
string
C1112712 (UMLS CUI)
10057755 (MDR)
Hematocrit:VFr:Pt:Bld:Qn:Automated count
Item
Hematocrit:VFr:Pt:Bld:Qn:Automated count
string
C0366777 (UMLS CUI)
4544-3 (LNC)
Leukocytes:NCnc:Pt:Bld:Qn:Automated count
Item
Leukocytes:NCnc:Pt:Bld:Qn:Automated count
string
C0484430 (UMLS CUI)
6690-2 (LNC)
Abnormal Blood Chemistry and Hematology Test Result
Item
Abnormal Blood Chemistry and Hematology Test Result
string
C1332129 (UMLS CUI)
Abnormal Laboratory Test Result
Item
Abnormal Laboratory Test Result
string
C0438215 (UMLS CUI)
10023547 (MDR)
309158009 (SNOMED CT 2010_0731)
Increased Creatinine
Item
Increased Creatinine
string
C0151578 (UMLS CUI)
E12137 (CTCAE)
10011368 (MDR)
Ventricular arrhythmia
Item
Ventricular arrhythmia
string
C0085612 (UMLS CUI)
10047281 (MDR)
44103008 (SNOMED CT 2010_0731)
Angina, Unstable
Item
Angina, Unstable
string
C0002965 (UMLS CUI)
I20.0 (ICD10CM)
411.1 (ICD9CM)
10002388 (MDR)
4557003 (SNOMED CT 2010_0731)
Myocardial Infarction
Item
Myocardial Infarction
string
C0027051 (UMLS CUI)
E10152 (CTCAE)
I21-I22 (ICD10CM)
10028596 (MDR)
22298006 (SNOMED CT 2010_0731)
Coronary Artery Bypass Surgery
Item
Coronary Artery Bypass Surgery
string
C0010055 (UMLS CUI)
36.10 (ICD9CM)
10011077 (MDR)
232717009 (SNOMED CT 2010_0731)
Percutaneous coronary intervention
Item
Percutaneous coronary intervention
string
C1532338 (UMLS CUI)
10065608 (MDR)
415070008 (SNOMED CT 2010_0731)
Revascularization - action
Item
Revascularization - action
string
C0581603 (UMLS CUI)
297183000 (SNOMED CT 2010_0731)
Structure of renal artery
Item
Structure of renal artery
string
C0035065 (UMLS CUI)
MTHU016747 (LNC)
2841007 (SNOMED CT 2010_0731)
Carotid Arteries
Item
Carotid Arteries
string
C0007272 (UMLS CUI)
MTHU011911 (LNC)
69105007 (SNOMED CT 2010_0731)
Transient Ischemic Attack
Item
Transient Ischemic Attack
string
C0007787 (UMLS CUI)
E12834 (CTCAE)
G45.9 (ICD10CM)
MTHU020810 (LNC)
10044390 (MDR)
266257000 (SNOMED CT 2010_0731)
Deep Vein Thrombosis
Item
Deep Vein Thrombosis
string
C0149871 (UMLS CUI)
I82.40 (ICD10CM)
MTHU020788 (LNC)
10051055 (MDR)
128053003 (SNOMED CT 2010_0731)
Chronic Obstructive Airway Disease
Item
Chronic Obstructive Airway Disease
string
C0024117 (UMLS CUI)
J44.9 (ICD10CM)
10009033 (MDR)
13645005 (SNOMED CT 2010_0731)
Partial Pressure of Oxygen Measurement
Item
Partial Pressure of Oxygen Measurement
string
C0202155 (UMLS CUI)
10035766 (MDR)
25579001 (SNOMED CT 2010_0731)
Partial Pressure of Carbon Dioxide Measurement
Item
Partial Pressure of Carbon Dioxide Measurement
string
C0201931 (UMLS CUI)
10034180 (MDR)
25284008 (SNOMED CT 2010_0731)
Lung function testing abnormal
Item
Lung function testing abnormal
string
C0476405 (UMLS CUI)
R94.2 (ICD10CM)
794.2 (ICD9CM)
10061602 (MDR)
165019004 (SNOMED CT 2010_0731)
Forced Expiratory Volume in 1 Second
Item
Forced Expiratory Volume in 1 Second
string
CL414841 (UMLS CUI)
Thrombocytopenia
Item
Thrombocytopenia
string
C0040034 (UMLS CUI)
E12207 (CTCAE)
D69.6 (ICD10CM)
287.5 (ICD9CM)
10043554 (MDR)
415116008 (SNOMED CT 2010_0731)
Platelet # Bld Auto
Item
Platelet # Bld Auto
string
C0362994 (UMLS CUI)
777-3 (LNC)
Hemodialysis
Item
Hemodialysis
string
C0019004 (UMLS CUI)
39.95 (ICD9CM)
10018875 (MDR)
302497006 (SNOMED CT 2010_0731)
Immunocompromised
Item
Immunocompromised
string
C0085393 (UMLS CUI)
370388006 (SNOMED CT 2010_0731)
Transplant Recipients
Item
Transplant Recipients
string
C0376387 (UMLS CUI)
Therapeutic immunosuppression
Item
Therapeutic immunosuppression
string
C0021079 (UMLS CUI)
86553008 (SNOMED CT 2010_0731)
Dementia
Item
Dementia
string
C0497327 (UMLS CUI)
F03 (ICD10CM)
290 (ICD9CM)
10012267 (MDR)
52448006 (SNOMED CT 2010_0731)
Alzheimer's Disease
Item
Alzheimer's Disease
string
C0002395 (UMLS CUI)
G30 (ICD10CM)
331.0 (ICD9CM)
10001896 (MDR)
26929004 (SNOMED CT 2010_0731)
Brain hemorrhage
Item
Brain hemorrhage
string
C0553692 (UMLS CUI)
10019016 (MDR)
230706003 (SNOMED CT 2010_0731)
Drug Allergy
Item
Drug Allergy
string
C0013182 (UMLS CUI)
DALG (HL7V3.0)
T88.7 (ICD10CM)
10013700 (MDR)
416098002 (SNOMED CT 2010_0731)
Contrast media allergy
Item
Contrast media allergy
string
C0570562 (UMLS CUI)
10066973 (MDR)
293637006 (SNOMED CT 2010_0731)
Negative Pregnancy Test
Item
Negative Pregnancy Test
string
C0427780 (UMLS CUI)
10036574 (MDR)
250425007 (SNOMED CT 2010_0731)
Breastfeeding
Item
Breastfeeding
string
C0006147 (UMLS CUI)
10006247 (MDR)
169741004 (SNOMED CT 2010_0731)
Contraceptive methods
Item
Contraceptive methods
string
C0700589 (UMLS CUI)
MTHU024530 (LNC)
10010808 (MDR)
13197004 (SNOMED CT 2010_0731)
Contraception, Barrier
Item
Contraception, Barrier
string
C0004764 (UMLS CUI)
225370004 (SNOMED CT 2010_0731)
Alcoholic Intoxication, Chronic
Item
Alcoholic Intoxication, Chronic
string
C0001973 (UMLS CUI)
F10.2 (ICD10CM)
303 (ICD9CM)
10001639 (MDR)
7200002 (SNOMED CT 2010_0731)
Mental disorders
Item
Mental disorders
string
C0004936 (UMLS CUI)
F01-F99 (ICD10CM)
290-319.99 (ICD9CM)
10061284 (MDR)
74732009 (SNOMED CT 2010_0731)
Drug abuse
Item
Drug abuse
string
C0013146 (UMLS CUI)
305 (ICD9CM)
MTHU019367 (LNC)
10013654 (MDR)
26416006 (SNOMED CT 2010_0731)
Experimental drug
Item
Experimental drug
string
C0304229 (UMLS CUI)
902003 (SNOMED CT 2010_0731)
Prior Gene Therapy
Item
Prior Gene Therapy
string
C1514459 (UMLS CUI)
Placebos
Item
Placebos
string
C0032042 (UMLS CUI)

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