ID

40497

Description

FFR or OCT Guidance to RevasculariZe Intermediate Coronary Stenosis Using Angioplasty; ODM derived from: https://clinicaltrials.gov/show/NCT01824030

Link

https://clinicaltrials.gov/show/NCT01824030

Keywords

Versions (1)
  1. 4/26/20 4/26/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 26, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Ischemic Heart Disease NCT01824030

English

Eligibility Ischemic Heart Disease NCT01824030

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
single vessel disease with an intermediate coronary artery stenosis
Description

Single vessel disease | Coronary Stenosis Intermediate

Data type

boolean

Alias
UMLS CUI [1]
C0856737
UMLS CUI [2,1]
C0242231
UMLS CUI [2,2]
C0205103
multivessel disease with multiple intermediate coronary artery stenosis only
Description

Multi vessel coronary artery disease | Coronary Stenosis Intermediate multiple

Data type

boolean

Alias
UMLS CUI [1]
C1299432
UMLS CUI [2,1]
C0242231
UMLS CUI [2,2]
C0205103
UMLS CUI [2,3]
C0439064
multivessel disease with already treated angiographically critical stenosis and at least one intermediate coronary artery stenosis
Description

Multi vessel coronary artery disease | Stenosis Critical Angiography | Stenosis Critical Treated | Coronary Stenosis Intermediate Quantity

Data type

boolean

Alias
UMLS CUI [1]
C1299432
UMLS CUI [2,1]
C1261287
UMLS CUI [2,2]
C1511545
UMLS CUI [2,3]
C0002978
UMLS CUI [3,1]
C1261287
UMLS CUI [3,2]
C1511545
UMLS CUI [3,3]
C1522326
UMLS CUI [4,1]
C0242231
UMLS CUI [4,2]
C0205103
UMLS CUI [4,3]
C1265611
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
age <18 years or impossibility to give informed consent,
Description

Age | Informed Consent Unable

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
female sex with child-bearing potential,
Description

Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C3831118
life expectancy of less than 12 months or factors making clinical follow-up difficult (no fixed address, etc),
Description

Life Expectancy | Factor Follow-up Difficult

Data type

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C1521761
UMLS CUI [2,2]
C3274571
UMLS CUI [2,3]
C0332218
poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%
Description

Cardiac function Poor | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1,1]
C0232164
UMLS CUI [1,2]
C0542537
UMLS CUI [2]
C0428772
recent (< 7 days) st-segment elevation myocardial infarction
Description

ST segment elevation myocardial infarction Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C1536220
UMLS CUI [1,2]
C0332185
recent (< 48 hours) non st-segment elevation myocardial infarction
Description

Non-ST Elevated Myocardial Infarction Recent

Data type

boolean

Alias
UMLS CUI [1,1]
C4255010
UMLS CUI [1,2]
C0332185
prior st-segment elevation myocardial infarction in the territory supplied by the vessel with the intermediate stenosis under investigation
Description

ST segment elevation myocardial infarction Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C1536220
UMLS CUI [1,2]
C0205156
severe myocardial hypertrophy (interventricular septum thickness > 15 mm, ecg sokolow's criteria fulfilled)
Description

Myocardial hypertrophy Severe | Ventricular septum Thickness

Data type

boolean

Alias
UMLS CUI [1,1]
C3495916
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0225870
UMLS CUI [2,2]
C1280412
severe valvular heart disease
Description

Heart valve disease Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C0205082
significant platelet count alteration (<100,000 cells/mm3 or > 700,000 cells/mm3)
Description

Platelet count altered significant | Platelet Count measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C1287267
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0750502
UMLS CUI [2]
C0032181
gastrointestinal bleeding requiring surgery or blood transfusions within 4 previous weeks
Description

Gastrointestinal Hemorrhage Requirement Operative Surgical Procedure | Gastrointestinal Hemorrhage Requirement Blood Transfusion

Data type

boolean

Alias
UMLS CUI [1,1]
C0017181
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0543467
UMLS CUI [2,1]
C0017181
UMLS CUI [2,2]
C1514873
UMLS CUI [2,3]
C0005841
history of clotting pathology
Description

Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C0005779
known hypersensitivity to aspirin, heparin, contrast dye
Description

Aspirin allergy | Heparin allergy | Contrast dye allergy

Data type

boolean

Alias
UMLS CUI [1]
C0004058
UMLS CUI [2]
C0571776
UMLS CUI [3]
C0742797
advance renal failure with glomerular filtration rate < 30 ml/min
Description

Kidney Failure Advanced | Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1,1]
C0035078
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C0017654
lesions in coronary artery bypass grafts
Description

Lesion Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C0221198
UMLS CUI [1,2]
C0010055
multivessel disease requiring coronary aortic bypass graft intervention
Description

Multi vessel coronary artery disease Requirement Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1,1]
C1299432
UMLS CUI [1,2]
C1514873
UMLS CUI [1,3]
C0010055
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Similar models

Eligibility Ischemic Heart Disease NCT01824030

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Single vessel disease | Coronary Stenosis Intermediate
Item
single vessel disease with an intermediate coronary artery stenosis
boolean
C0856737 (UMLS CUI [1])
C0242231 (UMLS CUI [2,1])
C0205103 (UMLS CUI [2,2])
Multi vessel coronary artery disease | Coronary Stenosis Intermediate multiple
Item
multivessel disease with multiple intermediate coronary artery stenosis only
boolean
C1299432 (UMLS CUI [1])
C0242231 (UMLS CUI [2,1])
C0205103 (UMLS CUI [2,2])
C0439064 (UMLS CUI [2,3])
Multi vessel coronary artery disease | Stenosis Critical Angiography | Stenosis Critical Treated | Coronary Stenosis Intermediate Quantity
Item
multivessel disease with already treated angiographically critical stenosis and at least one intermediate coronary artery stenosis
boolean
C1299432 (UMLS CUI [1])
C1261287 (UMLS CUI [2,1])
C1511545 (UMLS CUI [2,2])
C0002978 (UMLS CUI [2,3])
C1261287 (UMLS CUI [3,1])
C1511545 (UMLS CUI [3,2])
C1522326 (UMLS CUI [3,3])
C0242231 (UMLS CUI [4,1])
C0205103 (UMLS CUI [4,2])
C1265611 (UMLS CUI [4,3])
Item Group
C0680251 (UMLS CUI)
Age | Informed Consent Unable
Item
age <18 years or impossibility to give informed consent,
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])
Childbearing Potential
Item
female sex with child-bearing potential,
boolean
C3831118 (UMLS CUI [1])
Life Expectancy | Factor Follow-up Difficult
Item
life expectancy of less than 12 months or factors making clinical follow-up difficult (no fixed address, etc),
boolean
C0023671 (UMLS CUI [1])
C1521761 (UMLS CUI [2,1])
C3274571 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
Cardiac function Poor | Left ventricular ejection fraction
Item
poor cardiac function as defined by left ventricular global ejection fraction ≤ 30%
boolean
C0232164 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2])
ST segment elevation myocardial infarction Recent
Item
recent (< 7 days) st-segment elevation myocardial infarction
boolean
C1536220 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
Non-ST Elevated Myocardial Infarction Recent
Item
recent (< 48 hours) non st-segment elevation myocardial infarction
boolean
C4255010 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
ST segment elevation myocardial infarction Previous
Item
prior st-segment elevation myocardial infarction in the territory supplied by the vessel with the intermediate stenosis under investigation
boolean
C1536220 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Myocardial hypertrophy Severe | Ventricular septum Thickness
Item
severe myocardial hypertrophy (interventricular septum thickness > 15 mm, ecg sokolow's criteria fulfilled)
boolean
C3495916 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0225870 (UMLS CUI [2,1])
C1280412 (UMLS CUI [2,2])
Heart valve disease Severe
Item
severe valvular heart disease
boolean
C0018824 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Platelet count altered significant | Platelet Count measurement
Item
significant platelet count alteration (<100,000 cells/mm3 or > 700,000 cells/mm3)
boolean
C1287267 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0750502 (UMLS CUI [1,3])
C0032181 (UMLS CUI [2])
Gastrointestinal Hemorrhage Requirement Operative Surgical Procedure | Gastrointestinal Hemorrhage Requirement Blood Transfusion
Item
gastrointestinal bleeding requiring surgery or blood transfusions within 4 previous weeks
boolean
C0017181 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
C0017181 (UMLS CUI [2,1])
C1514873 (UMLS CUI [2,2])
C0005841 (UMLS CUI [2,3])
Blood Coagulation Disorders
Item
history of clotting pathology
boolean
C0005779 (UMLS CUI [1])
Aspirin allergy | Heparin allergy | Contrast dye allergy
Item
known hypersensitivity to aspirin, heparin, contrast dye
boolean
C0004058 (UMLS CUI [1])
C0571776 (UMLS CUI [2])
C0742797 (UMLS CUI [3])
Kidney Failure Advanced | Glomerular Filtration Rate
Item
advance renal failure with glomerular filtration rate < 30 ml/min
boolean
C0035078 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C0017654 (UMLS CUI [2])
Lesion Coronary Artery Bypass Surgery
Item
lesions in coronary artery bypass grafts
boolean
C0221198 (UMLS CUI [1,1])
C0010055 (UMLS CUI [1,2])
Multi vessel coronary artery disease Requirement Coronary Artery Bypass Surgery
Item
multivessel disease requiring coronary aortic bypass graft intervention
boolean
C1299432 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0010055 (UMLS CUI [1,3])
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