Eligibility Coronary Artery Disease NCT01114269

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StudyEvent: Eligibility
1. Eligibility Coronary Artery Disease NCT01114269

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Coronary Artery Disease | Prior myocardial infarction

Item

1. evidence of coronary artery disease (cad) a or documented prior myocardial infarction.

boolean

C1956346 (UMLS CUI [1])
C0155668 (UMLS CUI [2])

Left ventricular ejection fraction Echocardiogram | Left ventricular ejection fraction Multiple gated acquisition scanning | Left ventricular ejection fraction Angiography | Heart failure New York Heart Association Classification | Ventricular Tachyarrhythmia Absent | Induced ventricular tachycardia Absent | Cardiac Electrophysiology

Item

2. lvef >35% by any current standard evaluation technique (e.g.,) echocardiogram, muga, angiography). 2.1. patients who have an lvef between 30-35% and nyha class i heart failure who do not have history of ventricular tachyarrhythmias,or inducible ventricular tachycardia during electrophysiological (ep) testing can be enrolled.

boolean

C0428772 (UMLS CUI [1,1])
C2243117 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3,1])
C0002978 (UMLS CUI [3,2])
C0018801 (UMLS CUI [4,1])
C1275491 (UMLS CUI [4,2])
C0042514 (UMLS CUI [5,1])
C0332197 (UMLS CUI [5,2])
C0340486 (UMLS CUI [6,1])
C0332197 (UMLS CUI [6,2])
C0430467 (UMLS CUI [7])

Prior myocardial infarction Absent | Mild left ventricular systolic dysfunction | Moderate left ventricular systolic dysfunction | Cardiac ejection fraction Echocardiogram | Cardiac ejection fraction Multiple gated acquisition scanning | Cardiac ejection fraction Angiography

Item

3. if documented prior mi is not present, evidence of mild-moderate systolic left ventricular dysfunction with an ef >35- ≤50% as measured by any current standard screening technique (e.g.,echocardiogram, muga, angiography) must be present.

boolean

C0155668 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C3266750 (UMLS CUI [2])
C3266752 (UMLS CUI [3])
C0232174 (UMLS CUI [4,1])
C2243117 (UMLS CUI [4,2])
C0232174 (UMLS CUI [5,1])
C0521317 (UMLS CUI [5,2])
C0232174 (UMLS CUI [6,1])
C0002978 (UMLS CUI [6,2])

Age

Item

4. patients aged 18 years or above

boolean

C0001779 (UMLS CUI [1])

Coronary Artery Disease Criteria Quantity

Item

1. cad will be defined as evidence of one of the following two (2) criteria:

boolean

C1956346 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])

Stenosis Percentage Coronary angiography | Vessel Epicardial Major Proximal | Vessel Epicardial Major Distal

Item

significant stenosis of a major epicardial vessel (>50% proximal or 70% distal) by coronary angiography

boolean

C1261287 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0085532 (UMLS CUI [1,3])
C0005847 (UMLS CUI [2,1])
C0442016 (UMLS CUI [2,2])
C0205164 (UMLS CUI [2,3])
C0205107 (UMLS CUI [2,4])
C0005847 (UMLS CUI [3,1])
C0442016 (UMLS CUI [3,2])
C0205164 (UMLS CUI [3,3])
C0205108 (UMLS CUI [3,4])

Coronary revascularisation | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

Item

prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery)

boolean

C0877341 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
C0010055 (UMLS CUI [3])

Myocardial Infarction criteria

Item

2. mi can be documented in the following ways:

boolean

C0027051 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])

Myocardial Infarction Hospitalization | Cardiac biomarkers Percentile | Elevated creatine kinase | Troponin increased | Myocardial Ischemia

Item

from the mi hospitalization: detection of a rise and fall of cardiac biomarkers > 99th percentile of lab (e.g., cpk elevation or troponin at least > two times the upper limit of normal) together with myocardial ischemia with at least one of the following:

boolean

C0027051 (UMLS CUI [1,1])
C0019993 (UMLS CUI [1,2])
C2735102 (UMLS CUI [2,1])
C1264641 (UMLS CUI [2,2])
C0151576 (UMLS CUI [3])
C1141948 (UMLS CUI [4])
C0151744 (UMLS CUI [5])

Symptoms Ischemia

Item

symptoms of ischemia

boolean

C1457887 (UMLS CUI [1,1])
C0022116 (UMLS CUI [1,2])

Electrocardiographic changes Indication of Ischemia New | ST-T change New | Left bundle branch block New

Item

ecg changes indicative of new ischemia (new st-t changes or new lbbb)

boolean

C0855329 (UMLS CUI [1,1])
C0392360 (UMLS CUI [1,2])
C0022116 (UMLS CUI [1,3])
C0205314 (UMLS CUI [1,4])
C0919620 (UMLS CUI [2,1])
C0205314 (UMLS CUI [2,2])
C0344420 (UMLS CUI [3,1])
C0205314 (UMLS CUI [3,2])

Q waves Pathological

Item

development of pathological q waves

boolean

C1305738 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])

New Loss of Viable Myocardium Imaging | Cardiac wall motion dysfunction regional new

Item

imaging evidence of new loss of viable myocardium or new regional wall motion abnormality

boolean

C3898142 (UMLS CUI [1])
C2024793 (UMLS CUI [2,1])
C0205147 (UMLS CUI [2,2])
C0205314 (UMLS CUI [2,3])

Prior myocardial infarction criteria

Item

if no report from the mi hospitalization is available, prior mi can be met by either of the following:

boolean

C0155668 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])

Q waves Pathological

Item

development of pathological q waves

boolean

C1305738 (UMLS CUI [1,1])
C1521733 (UMLS CUI [1,2])

Loss of Viable Myocardium Imaging regional

Item

imaging evidence of a region of loss of viable myocardium that is thinned and fails to contract, in the absence of a non-ischaemic cause

boolean

C3898142 (UMLS CUI [1,1])
C0205147 (UMLS CUI [1,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Cardiac Arrest | Spontaneous Sustained Ventricular Tachycardia | Sustained ventricular tachycardia Inducible

Item

1. history of cardiac arrest or spontaneous or inducible sustained vt (15 beats or more at a rate of 120 bpm or greater - the occurrence of cardiac arrest or spontaneous vt in the setting of an acute mi is not considered an exclusion).

boolean

C0018790 (UMLS CUI [1])
C3272259 (UMLS CUI [2])
C0750197 (UMLS CUI [3,1])
C0205263 (UMLS CUI [3,2])

Syncope Unknown

Item

2. unexplained syncope

boolean

C0039070 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])

Implantable defibrillator | Implantable defibrillator Planned

Item

3. current or planned implantable cardiac defibrillator (icd)

boolean

C0162589 (UMLS CUI [1])
C0162589 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])

Condition Life Expectancy Limited Serious | Exception Heart Disease

Item

4. any condition other than cardiac disease that, in the investigator's judgment, would seriously limit life expectancy (poor survival)

boolean

C0348080 (UMLS CUI [1,1])
C0023671 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0205404 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])

Neoplasm Metastasis

Item

5. metastatic cancer

boolean

C0027627 (UMLS CUI [1])

Heart valve disease Marked Requirement Operative Surgical Procedures

Item

6. marked valvular heart disease requiring surgical intervention

boolean

C0018824 (UMLS CUI [1,1])
C1706089 (UMLS CUI [1,2])
C1514873 (UMLS CUI [1,3])
C0543467 (UMLS CUI [1,4])

Item

7. current or planned cardiac, renal or liver transplant

boolean

C0018823 (UMLS CUI [1])
C0022671 (UMLS CUI [2])
C0023911 (UMLS CUI [3])
C0018823 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0022671 (UMLS CUI [5,1])
C1301732 (UMLS CUI [5,2])
C0023911 (UMLS CUI [6,1])
C1301732 (UMLS CUI [6,2])

Substance Use Disorders

Item

8. current alcohol or drug abuse

boolean

C0038586 (UMLS CUI [1])

Informed Consent Unwilling | Informed Consent Unable

Item

9. unwilling or unable to provide informed consent

boolean

C0021430 (UMLS CUI [1,1])
C0558080 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1299582 (UMLS CUI [2,2])

Left ventricular ejection fraction | Congestive heart failure New York Heart Association Classification

Item

10. lvef <35% with class ii-iii chf or lvef <30%

boolean

C0428772 (UMLS CUI [1])
C0018802 (UMLS CUI [2,1])
C1275491 (UMLS CUI [2,2])

Study Subject Participation Status | Anti-Arrhythmia Agents | Intervention Against Cardiac Arrhythmia

Item

11. participation in a clinical trial where the active treatment arm is testing an agent and/or intervention with known antiarrhythmic properties

boolean

C2348568 (UMLS CUI [1])
C0003195 (UMLS CUI [2])
C0184661 (UMLS CUI [3,1])
C0521124 (UMLS CUI [3,2])
C0003811 (UMLS CUI [3,3])

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Eligibility Coronary Artery Disease NCT01114269