ID

40497

Descrizione

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

collegamento

https://clinicaltrials.gov/show/NCT01824030

Keywords

  1. 26/04/20 26/04/20 -
Titolare del copyright

See clinicaltrials.gov

Caricato su

26 aprile 2020

DOI

Per favore, per richiedere un accesso.

Licenza

Creative Commons BY 4.0

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Eligibility Ischemic Heart Disease NCT01824030

Eligibility Ischemic Heart Disease NCT01824030

Inclusion Criteria
Descrizione

Inclusion Criteria

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

Single vessel disease | Coronary Stenosis Intermediate

Tipo di dati

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
Descrizione

Multi vessel coronary artery disease | Coronary Stenosis Intermediate multiple

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Exclusion Criteria

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

Age | Informed Consent Unable

Tipo di dati

boolean

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

Childbearing Potential

Tipo di dati

boolean

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

Life Expectancy | Factor Follow-up Difficult

Tipo di dati

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%
Descrizione

Cardiac function Poor | Left ventricular ejection fraction

Tipo di dati

boolean

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

ST segment elevation myocardial infarction Recent

Tipo di dati

boolean

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

Non-ST Elevated Myocardial Infarction Recent

Tipo di dati

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
Descrizione

ST segment elevation myocardial infarction Previous

Tipo di dati

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)
Descrizione

Myocardial hypertrophy Severe | Ventricular septum Thickness

Tipo di dati

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
Descrizione

Heart valve disease Severe

Tipo di dati

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)
Descrizione

Platelet count altered significant | Platelet Count measurement

Tipo di dati

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
Descrizione

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

Tipo di dati

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
Descrizione

Blood Coagulation Disorders

Tipo di dati

boolean

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

Aspirin allergy | Heparin allergy | Contrast dye allergy

Tipo di dati

boolean

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

Kidney Failure Advanced | Glomerular Filtration Rate

Tipo di dati

boolean

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

Lesion Coronary Artery Bypass Surgery

Tipo di dati

boolean

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

Multi vessel coronary artery disease Requirement Coronary Artery Bypass Surgery

Tipo di dati

boolean

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

Similar models

Eligibility Ischemic Heart Disease NCT01824030

Name
genere
Description | Question | Decode (Coded Value)
Tipo di dati
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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