ID

23927

Beschreibung

Safety and Efficacy Study of PB127 Ultrasound Contrast Agent for Diagnosis of Coronary Artery Disease; ODM derived from: https://clinicaltrials.gov/show/NCT00584896

Link

https://clinicaltrials.gov/show/NCT00584896

Stichworte

Versionen (1)
  1. 18.07.17 18.07.17 -
Hochgeladen am

18. Juli 2017

DOI

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Lizenz

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Eligibility Coronary Artery Disease NCT00584896

Englisch

Eligibility Coronary Artery Disease NCT00584896

1 Formulare  
Criteria
Beschreibung

Criteria

2. all subjects must be scheduled for or have undergone spect within 28 days prior to or following study day 1
Beschreibung

SPECT Scheduled | SPECT

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0040399
UMLS CUI [1,2]
C0205539
UMLS CUI [2]
C0040399
3. subjects with very low/low pre-test probability of coronary artery disease must consent to participate in the extension trial 127-014-a
Beschreibung

Coronary Artery Disease Probability Very low | Coronary Artery Disease Probability low | Participation Clinical Trial Specified

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0033204
UMLS CUI [1,3]
C0442811
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0033204
UMLS CUI [2,3]
C0205251
UMLS CUI [3,1]
C0679823
UMLS CUI [3,2]
C0008976
UMLS CUI [3,3]
C0205369
4. subjects with very low/low pre-test probability of coronary artery disease must not have a current diagnosis of obstructive cad on angiogram or prior mi
Beschreibung

Coronary Artery Disease Probability Very low | Coronary Artery Disease Probability low | Coronary Artery Disease Obstructive Absent Angiography | Myocardial Infarction Absent

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0033204
UMLS CUI [1,3]
C0442811
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0033204
UMLS CUI [2,3]
C0205251
UMLS CUI [3,1]
C1956346
UMLS CUI [3,2]
C0549186
UMLS CUI [3,3]
C0332197
UMLS CUI [3,4]
C0002978
UMLS CUI [4,1]
C0027051
UMLS CUI [4,2]
C0332197
5. subjects with very low/low pre-test probability of coronary artery disease with a current diagnosis of obstructive cad on angiogram or prior mi may be enrolled into stratum 2
Beschreibung

Coronary Artery Disease Probability Very low | Coronary Artery Disease Probability low | Coronary Artery Disease Obstructive Angiography | Myocardial Infarction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0033204
UMLS CUI [1,3]
C0442811
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0033204
UMLS CUI [2,3]
C0205251
UMLS CUI [3,1]
C1956346
UMLS CUI [3,2]
C0549186
UMLS CUI [3,3]
C0002978
UMLS CUI [4]
C0027051
6. subjects with intermediate or high pre-test probability of coronary artery disease must be scheduled for coronary angiography within the 28 days following study day 1
Beschreibung

Coronary Artery Disease Probability Intermediate | Coronary Artery Disease Probability High | Coronary angiography Scheduled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0033204
UMLS CUI [1,3]
C0205103
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0033204
UMLS CUI [2,3]
C0205250
UMLS CUI [3,1]
C0085532
UMLS CUI [3,2]
C0205539
7. sinus rhythm at the time of the study procedure
Beschreibung

Sinus rhythm

Datentyp

boolean

Alias
UMLS CUI [1]
C0232201
8. adequate visualization of myocardial segments
Beschreibung

Visualization Segment Myocardial

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0178707
UMLS CUI [1,2]
C0441635
UMLS CUI [1,3]
C1522564
9. appropriate candidate for stress testing according to acc/aha guidelines for exercise testing
Beschreibung

Patient Appropriate Exercise stress test

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0015260
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. women who are pregnant or lactating
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
2. known hypersensitivity or known contraindication to:
Beschreibung

Hypersensitivity | Medical contraindication

Datentyp

boolean

Alias
UMLS CUI [1]
C0020517
UMLS CUI [2]
C1301624
1. dipyridamole
Beschreibung

Dipyridamole

Datentyp

boolean

Alias
UMLS CUI [1]
C0012582
2. ultrasound contrast agents (including pb127 and excipients)
Beschreibung

Contrast Agent for Ultrasound Imaging | PB-127 | PB-127 Excipient

Datentyp

boolean

Alias
UMLS CUI [1]
C2917331
UMLS CUI [2]
C1959382
UMLS CUI [3,1]
C1959382
UMLS CUI [3,2]
C0015237
3. blood, blood products, albumin, egg, or protein
Beschreibung

Blood | Blood product | Albumins | Egg | Proteins

Datentyp

boolean

Alias
UMLS CUI [1]
C0005767
UMLS CUI [2]
C0456388
UMLS CUI [3]
C0001924
UMLS CUI [4]
C0013710
UMLS CUI [5]
C0033684
3. use of caffeine or xanthine containing products within the 24 hours prior to study day 1
Beschreibung

Caffeine products | Product Containing Xanthine

Datentyp

boolean

Alias
UMLS CUI [1]
C0006644
UMLS CUI [2,1]
C1514468
UMLS CUI [2,2]
C0332256
UMLS CUI [2,3]
C0043314
4. previous exposure to pb127 ultrasound contrast agent
Beschreibung

Exposure to PB-127 Contrast Agent for Ultrasound Imaging

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0332157
UMLS CUI [1,2]
C1959382
UMLS CUI [1,3]
C2917331
5. major surgery within 7 days prior to study day 1 (requiring general anesthesia and/or overnight stay)
Beschreibung

Major surgery Requirement General Anesthesia | Major surgery Requirement Overnight dwell

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0679637
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0002915
UMLS CUI [2,1]
C0679637
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C4072787
6. heart transplant or history of cabg
Beschreibung

Heart Transplantation | Coronary Artery Bypass Surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C0018823
UMLS CUI [2]
C0010055
7. known hemodynamically significant or symptomatic right-to-left shunt (including shunts that are associated with prior tias or strokes)
Beschreibung

Right to left cardiovascular shunt Significant Hemodynamic | Right to left cardiovascular shunt Symptomatic | Cardiac shunt Associated with Transient Ischemic Attack | Cardiac shunt Associated with Cerebrovascular accident

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0428871
UMLS CUI [1,2]
C0750502
UMLS CUI [1,3]
C0019010
UMLS CUI [2,1]
C0428871
UMLS CUI [2,2]
C0231220
UMLS CUI [3,1]
C0232180
UMLS CUI [3,2]
C0332281
UMLS CUI [3,3]
C0007787
UMLS CUI [4,1]
C0232180
UMLS CUI [4,2]
C0332281
UMLS CUI [4,3]
C0038454
8. recent history of sustained ventricular tachycardia
Beschreibung

Sustained ventricular tachycardia

Datentyp

boolean

Alias
UMLS CUI [1]
C0750197
9. pacemaker or defibrillator
Beschreibung

Artificial cardiac pacemaker | Defibrillators

Datentyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0180307
10. unstable cardiac status
Beschreibung

Cardiac Status Unstable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1999091
UMLS CUI [1,2]
C0443343
1. unstable angina grade ccs class iv severity (any physical activity causes limiting symptoms; symptoms may be present at rest in a patient with prior exertional angina) with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin
Beschreibung

Unstable Angina Canadian Cardiovascular Society classification of angina | Physical activity causes Symptoms Limiting | Symptoms At rest Exercise-induced angina | Symptoms Continuous | Nitroglycerin Intravenous infusion

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0002965
UMLS CUI [1,2]
C1277207
UMLS CUI [2,1]
C0026606
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C1457887
UMLS CUI [2,4]
C0439801
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0443144
UMLS CUI [3,3]
C0577698
UMLS CUI [4,1]
C1457887
UMLS CUI [4,2]
C0549178
UMLS CUI [5,1]
C0017887
UMLS CUI [5,2]
C0021440
2. decompensated heart failure
Beschreibung

Decompensated cardiac failure

Datentyp

boolean

Alias
UMLS CUI [1]
C0581377
3. second-degree or greater heart block, sick sinus syndrome
Beschreibung

Second degree atrioventricular block | Complete atrioventricular block | Sick Sinus Syndrome

Datentyp

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
UMLS CUI [3]
C0037052
4. frequent (>60/hour) or symptomatic ventricular ectopics at baseline
Beschreibung

Ventricular ectopics Frequently | Ventricular ectopics Symptomatic

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0428994
UMLS CUI [1,2]
C0332183
UMLS CUI [2,1]
C0428994
UMLS CUI [2,2]
C0231220
5. hypertension (sbp >200 and/or dbp >110 mmhg on two consecutive readings within one hour of pb127 mpe)
Beschreibung

Hypertensive disease | Systolic Pressure | Diastolic blood pressure | Blood pressure determination Consecutive Quantity | PB-127 compound

Datentyp

boolean

Alias
UMLS CUI [1]
C0020538
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4,1]
C0005824
UMLS CUI [4,2]
C1707491
UMLS CUI [4,3]
C1265611
UMLS CUI [5]
C1959382
6. hypotension (sbp <90 mmhg)
Beschreibung

Hypotension | Systolic Pressure

Datentyp

boolean

Alias
UMLS CUI [1]
C0020649
UMLS CUI [2]
C0871470
7. severe aortic stenosis (>40 mmhg mean gradient or <0.6 cm2/m2 valve area index)
Beschreibung

Aortic stenosis, severe | Gradient mean | Aortic valve area Index

Datentyp

boolean

Alias
UMLS CUI [1]
C3806272
UMLS CUI [2,1]
C0812409
UMLS CUI [2,2]
C0444504
UMLS CUI [3,1]
C0428817
UMLS CUI [3,2]
C0918012
8. pulmonary edema within the 7 days prior to study day 1
Beschreibung

Pulmonary Edema

Datentyp

boolean

Alias
UMLS CUI [1]
C0034063
9. resting oxygen saturation of less than 90% on room air
Beschreibung

Oxygen saturation At rest Percentage on room air

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0523807
UMLS CUI [1,2]
C0443144
UMLS CUI [1,3]
C0439165
UMLS CUI [1,4]
C2709070
11. myocardial infarction or cerebral vascular accident / transient ischemic attack within the 28 days prior to study day 1
Beschreibung

Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack

Datentyp

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0038454
UMLS CUI [3]
C0007787
12. chronic obstructive pulmonary disease (copd) or bronchospastic airway disease, which in the opinion of the investigator, is significant enough to contraindicate dipyridamole
Beschreibung

Chronic Obstructive Airway Disease | Bronchial Spasm | Medical contraindication Dipyridamole

Datentyp

boolean

Alias
UMLS CUI [1]
C0024117
UMLS CUI [2]
C0006266
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0012582
13. known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmhg
Beschreibung

Pulmonary Hypertension Severe | Pulmonary artery systolic pressure Estimated

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0428643
UMLS CUI [2,2]
C0750572
14. liver disease characterized by one or more of the following
Beschreibung

Liver disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0023895
1. current jaundice
Beschreibung

Icterus

Datentyp

boolean

Alias
UMLS CUI [1]
C0022346
2. elevated bilirubin > upper limit of normal
Beschreibung

Increased bilirubin level

Datentyp

boolean

Alias
UMLS CUI [1]
C0311468
3. currently elevated hepatic enzymes > 2x upper limit of normal
Beschreibung

Elevated liver enzymes

Datentyp

boolean

Alias
UMLS CUI [1]
C0235996
4. current or previous hepatic viral infection (not including hepatitis a)
Beschreibung

Viral hepatitis | Hepatitis A Excluded

Datentyp

boolean

Alias
UMLS CUI [1]
C0042721
UMLS CUI [2,1]
C0019159
UMLS CUI [2,2]
C2828389
5. chronic hepatitis
Beschreibung

Hepatitis, Chronic

Datentyp

boolean

Alias
UMLS CUI [1]
C0019189
15. medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives (i.e., drug dependence, psychiatric disorder, dementia, or associated illness); extenuating circumstances or medical conditions that make it unlikely that a patient can complete the clinical trial or follow up evaluations; or other reasons for expected poor compliance with the clinical investigator's instructions.
Beschreibung

Medical condition Interferes with Study data | Circumstance Interferes with Study data | Medical condition Interferes with Research results | Circumstance Interferes with Research results | Drug Dependence | Mental disorders | Dementia | Associated disease | Medical condition Protocol Compliance Unlikely | Circumstance Protocol Compliance Unlikely

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0681873
UMLS CUI [2,1]
C0868647
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0681873
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
UMLS CUI [4,1]
C0868647
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C0683954
UMLS CUI [5]
C1510472
UMLS CUI [6]
C0004936
UMLS CUI [7]
C0497327
UMLS CUI [8]
C0243083
UMLS CUI [9,1]
C3843040
UMLS CUI [9,2]
C0525058
UMLS CUI [9,3]
C0750558
UMLS CUI [10,1]
C0868647
UMLS CUI [10,2]
C0525058
UMLS CUI [10,3]
C0750558
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Ähnliche Modelle

Eligibility Coronary Artery Disease NCT00584896

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
SPECT Scheduled | SPECT
Item
2. all subjects must be scheduled for or have undergone spect within 28 days prior to or following study day 1
boolean
C0040399 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0040399 (UMLS CUI [2])
Coronary Artery Disease Probability Very low | Coronary Artery Disease Probability low | Participation Clinical Trial Specified
Item
3. subjects with very low/low pre-test probability of coronary artery disease must consent to participate in the extension trial 127-014-a
boolean
C1956346 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
C0442811 (UMLS CUI [1,3])
C1956346 (UMLS CUI [2,1])
C0033204 (UMLS CUI [2,2])
C0205251 (UMLS CUI [2,3])
C0679823 (UMLS CUI [3,1])
C0008976 (UMLS CUI [3,2])
C0205369 (UMLS CUI [3,3])
Coronary Artery Disease Probability Very low | Coronary Artery Disease Probability low | Coronary Artery Disease Obstructive Absent Angiography | Myocardial Infarction Absent
Item
4. subjects with very low/low pre-test probability of coronary artery disease must not have a current diagnosis of obstructive cad on angiogram or prior mi
boolean
C1956346 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
C0442811 (UMLS CUI [1,3])
C1956346 (UMLS CUI [2,1])
C0033204 (UMLS CUI [2,2])
C0205251 (UMLS CUI [2,3])
C1956346 (UMLS CUI [3,1])
C0549186 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
C0002978 (UMLS CUI [3,4])
C0027051 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Coronary Artery Disease Probability Very low | Coronary Artery Disease Probability low | Coronary Artery Disease Obstructive Angiography | Myocardial Infarction
Item
5. subjects with very low/low pre-test probability of coronary artery disease with a current diagnosis of obstructive cad on angiogram or prior mi may be enrolled into stratum 2
boolean
C1956346 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
C0442811 (UMLS CUI [1,3])
C1956346 (UMLS CUI [2,1])
C0033204 (UMLS CUI [2,2])
C0205251 (UMLS CUI [2,3])
C1956346 (UMLS CUI [3,1])
C0549186 (UMLS CUI [3,2])
C0002978 (UMLS CUI [3,3])
C0027051 (UMLS CUI [4])
Coronary Artery Disease Probability Intermediate | Coronary Artery Disease Probability High | Coronary angiography Scheduled
Item
6. subjects with intermediate or high pre-test probability of coronary artery disease must be scheduled for coronary angiography within the 28 days following study day 1
boolean
C1956346 (UMLS CUI [1,1])
C0033204 (UMLS CUI [1,2])
C0205103 (UMLS CUI [1,3])
C1956346 (UMLS CUI [2,1])
C0033204 (UMLS CUI [2,2])
C0205250 (UMLS CUI [2,3])
C0085532 (UMLS CUI [3,1])
C0205539 (UMLS CUI [3,2])
Sinus rhythm
Item
7. sinus rhythm at the time of the study procedure
boolean
C0232201 (UMLS CUI [1])
Visualization Segment Myocardial
Item
8. adequate visualization of myocardial segments
boolean
C0178707 (UMLS CUI [1,1])
C0441635 (UMLS CUI [1,2])
C1522564 (UMLS CUI [1,3])
Patient Appropriate Exercise stress test
Item
9. appropriate candidate for stress testing according to acc/aha guidelines for exercise testing
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0015260 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Pregnancy | Breast Feeding
Item
1. women who are pregnant or lactating
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Hypersensitivity | Medical contraindication
Item
2. known hypersensitivity or known contraindication to:
boolean
C0020517 (UMLS CUI [1])
C1301624 (UMLS CUI [2])
Dipyridamole
Item
1. dipyridamole
boolean
C0012582 (UMLS CUI [1])
Contrast Agent for Ultrasound Imaging | PB-127 | PB-127 Excipient
Item
2. ultrasound contrast agents (including pb127 and excipients)
boolean
C2917331 (UMLS CUI [1])
C1959382 (UMLS CUI [2])
C1959382 (UMLS CUI [3,1])
C0015237 (UMLS CUI [3,2])
Blood | Blood product | Albumins | Egg | Proteins
Item
3. blood, blood products, albumin, egg, or protein
boolean
C0005767 (UMLS CUI [1])
C0456388 (UMLS CUI [2])
C0001924 (UMLS CUI [3])
C0013710 (UMLS CUI [4])
C0033684 (UMLS CUI [5])
Caffeine products | Product Containing Xanthine
Item
3. use of caffeine or xanthine containing products within the 24 hours prior to study day 1
boolean
C0006644 (UMLS CUI [1])
C1514468 (UMLS CUI [2,1])
C0332256 (UMLS CUI [2,2])
C0043314 (UMLS CUI [2,3])
Exposure to PB-127 Contrast Agent for Ultrasound Imaging
Item
4. previous exposure to pb127 ultrasound contrast agent
boolean
C0332157 (UMLS CUI [1,1])
C1959382 (UMLS CUI [1,2])
C2917331 (UMLS CUI [1,3])
Major surgery Requirement General Anesthesia | Major surgery Requirement Overnight dwell
Item
5. major surgery within 7 days prior to study day 1 (requiring general anesthesia and/or overnight stay)
boolean
C0679637 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0002915 (UMLS CUI [1,3])
C0679637 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C4072787 (UMLS CUI [2,3])
Heart Transplantation | Coronary Artery Bypass Surgery
Item
6. heart transplant or history of cabg
boolean
C0018823 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
Right to left cardiovascular shunt Significant Hemodynamic | Right to left cardiovascular shunt Symptomatic | Cardiac shunt Associated with Transient Ischemic Attack | Cardiac shunt Associated with Cerebrovascular accident
Item
7. known hemodynamically significant or symptomatic right-to-left shunt (including shunts that are associated with prior tias or strokes)
boolean
C0428871 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
C0019010 (UMLS CUI [1,3])
C0428871 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0232180 (UMLS CUI [3,1])
C0332281 (UMLS CUI [3,2])
C0007787 (UMLS CUI [3,3])
C0232180 (UMLS CUI [4,1])
C0332281 (UMLS CUI [4,2])
C0038454 (UMLS CUI [4,3])
Sustained ventricular tachycardia
Item
8. recent history of sustained ventricular tachycardia
boolean
C0750197 (UMLS CUI [1])
Artificial cardiac pacemaker | Defibrillators
Item
9. pacemaker or defibrillator
boolean
C0030163 (UMLS CUI [1])
C0180307 (UMLS CUI [2])
Cardiac Status Unstable
Item
10. unstable cardiac status
boolean
C1999091 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
Unstable Angina Canadian Cardiovascular Society classification of angina | Physical activity causes Symptoms Limiting | Symptoms At rest Exercise-induced angina | Symptoms Continuous | Nitroglycerin Intravenous infusion
Item
1. unstable angina grade ccs class iv severity (any physical activity causes limiting symptoms; symptoms may be present at rest in a patient with prior exertional angina) with ongoing symptoms and/or ongoing infusion of intravenous nitroglycerin
boolean
C0002965 (UMLS CUI [1,1])
C1277207 (UMLS CUI [1,2])
C0026606 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C1457887 (UMLS CUI [2,3])
C0439801 (UMLS CUI [2,4])
C1457887 (UMLS CUI [3,1])
C0443144 (UMLS CUI [3,2])
C0577698 (UMLS CUI [3,3])
C1457887 (UMLS CUI [4,1])
C0549178 (UMLS CUI [4,2])
C0017887 (UMLS CUI [5,1])
C0021440 (UMLS CUI [5,2])
Decompensated cardiac failure
Item
2. decompensated heart failure
boolean
C0581377 (UMLS CUI [1])
Second degree atrioventricular block | Complete atrioventricular block | Sick Sinus Syndrome
Item
3. second-degree or greater heart block, sick sinus syndrome
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C0037052 (UMLS CUI [3])
Ventricular ectopics Frequently | Ventricular ectopics Symptomatic
Item
4. frequent (>60/hour) or symptomatic ventricular ectopics at baseline
boolean
C0428994 (UMLS CUI [1,1])
C0332183 (UMLS CUI [1,2])
C0428994 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
Hypertensive disease | Systolic Pressure | Diastolic blood pressure | Blood pressure determination Consecutive Quantity | PB-127 compound
Item
5. hypertension (sbp >200 and/or dbp >110 mmhg on two consecutive readings within one hour of pb127 mpe)
boolean
C0020538 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0005824 (UMLS CUI [4,1])
C1707491 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
C1959382 (UMLS CUI [5])
Hypotension | Systolic Pressure
Item
6. hypotension (sbp <90 mmhg)
boolean
C0020649 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
Aortic stenosis, severe | Gradient mean | Aortic valve area Index
Item
7. severe aortic stenosis (>40 mmhg mean gradient or <0.6 cm2/m2 valve area index)
boolean
C3806272 (UMLS CUI [1])
C0812409 (UMLS CUI [2,1])
C0444504 (UMLS CUI [2,2])
C0428817 (UMLS CUI [3,1])
C0918012 (UMLS CUI [3,2])
Pulmonary Edema
Item
8. pulmonary edema within the 7 days prior to study day 1
boolean
C0034063 (UMLS CUI [1])
Oxygen saturation At rest Percentage on room air
Item
9. resting oxygen saturation of less than 90% on room air
boolean
C0523807 (UMLS CUI [1,1])
C0443144 (UMLS CUI [1,2])
C0439165 (UMLS CUI [1,3])
C2709070 (UMLS CUI [1,4])
Myocardial Infarction | Cerebrovascular accident | Transient Ischemic Attack
Item
11. myocardial infarction or cerebral vascular accident / transient ischemic attack within the 28 days prior to study day 1
boolean
C0027051 (UMLS CUI [1])
C0038454 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
Chronic Obstructive Airway Disease | Bronchial Spasm | Medical contraindication Dipyridamole
Item
12. chronic obstructive pulmonary disease (copd) or bronchospastic airway disease, which in the opinion of the investigator, is significant enough to contraindicate dipyridamole
boolean
C0024117 (UMLS CUI [1])
C0006266 (UMLS CUI [2])
C1301624 (UMLS CUI [3,1])
C0012582 (UMLS CUI [3,2])
Pulmonary Hypertension Severe | Pulmonary artery systolic pressure Estimated
Item
13. known history of severe pulmonary hypertension characterized by estimated pulmonary artery systolic pressure of >50 mmhg
boolean
C0020542 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0428643 (UMLS CUI [2,1])
C0750572 (UMLS CUI [2,2])
Liver disease
Item
14. liver disease characterized by one or more of the following
boolean
C0023895 (UMLS CUI [1])
Icterus
Item
1. current jaundice
boolean
C0022346 (UMLS CUI [1])
Increased bilirubin level
Item
2. elevated bilirubin > upper limit of normal
boolean
C0311468 (UMLS CUI [1])
Elevated liver enzymes
Item
3. currently elevated hepatic enzymes > 2x upper limit of normal
boolean
C0235996 (UMLS CUI [1])
Viral hepatitis | Hepatitis A Excluded
Item
4. current or previous hepatic viral infection (not including hepatitis a)
boolean
C0042721 (UMLS CUI [1])
C0019159 (UMLS CUI [2,1])
C2828389 (UMLS CUI [2,2])
Hepatitis, Chronic
Item
5. chronic hepatitis
boolean
C0019189 (UMLS CUI [1])
Medical condition Interferes with Study data | Circumstance Interferes with Study data | Medical condition Interferes with Research results | Circumstance Interferes with Research results | Drug Dependence | Mental disorders | Dementia | Associated disease | Medical condition Protocol Compliance Unlikely | Circumstance Protocol Compliance Unlikely
Item
15. medical conditions or other circumstances that would significantly decrease the chances of obtaining reliable data or achieving the study objectives (i.e., drug dependence, psychiatric disorder, dementia, or associated illness); extenuating circumstances or medical conditions that make it unlikely that a patient can complete the clinical trial or follow up evaluations; or other reasons for expected poor compliance with the clinical investigator's instructions.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0681873 (UMLS CUI [1,3])
C0868647 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0681873 (UMLS CUI [2,3])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
C0868647 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C0683954 (UMLS CUI [4,3])
C1510472 (UMLS CUI [5])
C0004936 (UMLS CUI [6])
C0497327 (UMLS CUI [7])
C0243083 (UMLS CUI [8])
C3843040 (UMLS CUI [9,1])
C0525058 (UMLS CUI [9,2])
C0750558 (UMLS CUI [9,3])
C0868647 (UMLS CUI [10,1])
C0525058 (UMLS CUI [10,2])
C0750558 (UMLS CUI [10,3])
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