ID

35582

Description

A Comparison of Optical Coherence Tomography Guidance and Angiography-only Guidance for Percutaneous Coronary Intervention With Bioresorbable Vascular Scaffold; ODM derived from: https://clinicaltrials.gov/show/NCT02466282

Link

https://clinicaltrials.gov/show/NCT02466282

Keywords

Versions (1)
  1. 3/11/19 3/11/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 11, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT02466282

English

Eligibility Coronary Artery Disease NCT02466282

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients ≥ 19 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patients with ischemic heart disease who are considered for coronary revascularization with pci
Description

Myocardial Ischemia | Coronary revascularisation considered | Percutaneous Coronary Intervention considered

Data type

boolean

Alias
UMLS CUI [1]
C0151744
UMLS CUI [2,1]
C0877341
UMLS CUI [2,2]
C0750591
UMLS CUI [3,1]
C1532338
UMLS CUI [3,2]
C0750591
significant coronary de novo lesion (stenosis > 70% by quantitative angiographic analysis) treated by single bvs ≤ 25mm
Description

Lesion de novo Coronary artery | Stenosis Percentage Quantitative Coronary Angiography | Bioabsorbable scaffold Single

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1515568
UMLS CUI [1,3]
C0205042
UMLS CUI [2,1]
C1261287
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C4054139
UMLS CUI [3,1]
C4264469
UMLS CUI [3,2]
C0205171
reference vessel diameter of 2.5 to 3.5 mm by operator assessment
Description

Reference Vessel Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C1706462
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C1301886
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
myocardial infarction
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
Description

Lesion morphological complex | Lesion Aorta Ostium | Lesion Left coronary artery main stem | Chronic total occlusion of coronary artery | Lesion Graft | Thrombosis | Restenosis

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0543482
UMLS CUI [1,3]
C0439855
UMLS CUI [2,1]
C0221198
UMLS CUI [2,2]
C0003483
UMLS CUI [2,3]
C0444567
UMLS CUI [3,1]
C0221198
UMLS CUI [3,2]
C0226031
UMLS CUI [4]
C1955779
UMLS CUI [5,1]
C0221198
UMLS CUI [5,2]
C0332835
UMLS CUI [6]
C0040053
UMLS CUI [7]
C0333186
reference vessel diameter <2.5 mm or >3.5 mm
Description

Reference Vessel Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C1706462
UMLS CUI [1,2]
C0005847
UMLS CUI [1,3]
C1301886
heavy calcified lesions (definite calcified lesions on angiogram)
Description

Lesion Calcified Very Angiogram

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0175895
UMLS CUI [1,3]
C0442824
UMLS CUI [1,4]
C0002978
lesions requiring 2 or more bvs
Description

Lesion Requirement Bioabsorbable scaffold Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C4264469
UMLS CUI [1,4]
C1265611
contraindication or hypersensitivity to anti-platelet agents or contrast media
Description

Medical contraindication Antiplatelet Agents | Hypersensitivity Antiplatelet Agents | Medical contraindication Contrast Media | Contrast media allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0085826
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0085826
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C0009924
UMLS CUI [4]
C0570562
treated with any metallic stent or bvs within 3 months at other vessel
Description

Treatment Vessel | Stent Metallic | Bioabsorbable scaffold Metallic

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0005847
UMLS CUI [2,1]
C0038257
UMLS CUI [2,2]
C2986473
UMLS CUI [3,1]
C4264469
UMLS CUI [3,2]
C2986473
creatinine level ≥ 2.0 mg/dl or esrd
Description

Creatinine measurement, serum | Kidney Failure, Chronic

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0022661
severe hepatic dysfunction (3 times normal reference values)
Description

Liver Dysfunction Severe | Laboratory Results Above reference range

Data type

boolean

Alias
UMLS CUI [1,1]
C0086565
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C1254595
UMLS CUI [2,2]
C0460095
pregnant women or women with potential childbearing
Description

Pregnancy | Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C3831118
inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
Description

Follow-up unable

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1299582
inability to understand or read the informed content
Description

Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
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Similar models

Eligibility Coronary Artery Disease NCT02466282

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patients ≥ 19 years old
boolean
C0001779 (UMLS CUI [1])
Myocardial Ischemia | Coronary revascularisation considered | Percutaneous Coronary Intervention considered
Item
patients with ischemic heart disease who are considered for coronary revascularization with pci
boolean
C0151744 (UMLS CUI [1])
C0877341 (UMLS CUI [2,1])
C0750591 (UMLS CUI [2,2])
C1532338 (UMLS CUI [3,1])
C0750591 (UMLS CUI [3,2])
Lesion de novo Coronary artery | Stenosis Percentage Quantitative Coronary Angiography | Bioabsorbable scaffold Single
Item
significant coronary de novo lesion (stenosis > 70% by quantitative angiographic analysis) treated by single bvs ≤ 25mm
boolean
C0221198 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
C0205042 (UMLS CUI [1,3])
C1261287 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C4054139 (UMLS CUI [2,3])
C4264469 (UMLS CUI [3,1])
C0205171 (UMLS CUI [3,2])
Reference Vessel Diameter
Item
reference vessel diameter of 2.5 to 3.5 mm by operator assessment
boolean
C1706462 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Myocardial Infarction
Item
myocardial infarction
boolean
C0027051 (UMLS CUI [1])
Lesion morphological complex | Lesion Aorta Ostium | Lesion Left coronary artery main stem | Chronic total occlusion of coronary artery | Lesion Graft | Thrombosis | Restenosis
Item
complex lesion morphologies such as aorta-ostial, unprotected left main, chronic total occlusion, graft, thrombosis, and restenosis
boolean
C0221198 (UMLS CUI [1,1])
C0543482 (UMLS CUI [1,2])
C0439855 (UMLS CUI [1,3])
C0221198 (UMLS CUI [2,1])
C0003483 (UMLS CUI [2,2])
C0444567 (UMLS CUI [2,3])
C0221198 (UMLS CUI [3,1])
C0226031 (UMLS CUI [3,2])
C1955779 (UMLS CUI [4])
C0221198 (UMLS CUI [5,1])
C0332835 (UMLS CUI [5,2])
C0040053 (UMLS CUI [6])
C0333186 (UMLS CUI [7])
Reference Vessel Diameter
Item
reference vessel diameter <2.5 mm or >3.5 mm
boolean
C1706462 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
Lesion Calcified Very Angiogram
Item
heavy calcified lesions (definite calcified lesions on angiogram)
boolean
C0221198 (UMLS CUI [1,1])
C0175895 (UMLS CUI [1,2])
C0442824 (UMLS CUI [1,3])
C0002978 (UMLS CUI [1,4])
Lesion Requirement Bioabsorbable scaffold Quantity
Item
lesions requiring 2 or more bvs
boolean
C0221198 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C4264469 (UMLS CUI [1,3])
C1265611 (UMLS CUI [1,4])
Medical contraindication Antiplatelet Agents | Hypersensitivity Antiplatelet Agents | Medical contraindication Contrast Media | Contrast media allergy
Item
contraindication or hypersensitivity to anti-platelet agents or contrast media
boolean
C1301624 (UMLS CUI [1,1])
C0085826 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0085826 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C0009924 (UMLS CUI [3,2])
C0570562 (UMLS CUI [4])
Treatment Vessel | Stent Metallic | Bioabsorbable scaffold Metallic
Item
treated with any metallic stent or bvs within 3 months at other vessel
boolean
C0087111 (UMLS CUI [1,1])
C0005847 (UMLS CUI [1,2])
C0038257 (UMLS CUI [2,1])
C2986473 (UMLS CUI [2,2])
C4264469 (UMLS CUI [3,1])
C2986473 (UMLS CUI [3,2])
Creatinine measurement, serum | Kidney Failure, Chronic
Item
creatinine level ≥ 2.0 mg/dl or esrd
boolean
C0201976 (UMLS CUI [1])
C0022661 (UMLS CUI [2])
Liver Dysfunction Severe | Laboratory Results Above reference range
Item
severe hepatic dysfunction (3 times normal reference values)
boolean
C0086565 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C1254595 (UMLS CUI [2,1])
C0460095 (UMLS CUI [2,2])
Pregnancy | Childbearing Potential
Item
pregnant women or women with potential childbearing
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2])
Follow-up unable
Item
inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
boolean
C3274571 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Informed Consent Unable
Item
inability to understand or read the informed content
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
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