ID

28721

Beskrivning

PRE-DETERMINE Cohort Study; ODM derived from: https://clinicaltrials.gov/show/NCT01114269

Länk

https://clinicaltrials.gov/show/NCT01114269

Nyckelord

Versioner (1)
  1. 2018-01-28 2018-01-28 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

28 januari 2018

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT01114269

Engelsk

Eligibility Coronary Artery Disease NCT01114269

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. evidence of coronary artery disease (cad) a or documented prior myocardial infarction.
Beskrivning

Coronary Artery Disease | Prior myocardial infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C1956346
UMLS CUI [2]
C0155668
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.
Beskrivning

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

Datatyp

boolean

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

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0155668
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C3266750
UMLS CUI [3]
C3266752
UMLS CUI [4,1]
C0232174
UMLS CUI [4,2]
C2243117
UMLS CUI [5,1]
C0232174
UMLS CUI [5,2]
C0521317
UMLS CUI [6,1]
C0232174
UMLS CUI [6,2]
C0002978
4. patients aged 18 years or above
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
1. cad will be defined as evidence of one of the following two (2) criteria:
Beskrivning

Coronary Artery Disease Criteria Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0243161
UMLS CUI [1,3]
C1265611
significant stenosis of a major epicardial vessel (>50% proximal or 70% distal) by coronary angiography
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1261287
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0085532
UMLS CUI [2,1]
C0005847
UMLS CUI [2,2]
C0442016
UMLS CUI [2,3]
C0205164
UMLS CUI [2,4]
C0205107
UMLS CUI [3,1]
C0005847
UMLS CUI [3,2]
C0442016
UMLS CUI [3,3]
C0205164
UMLS CUI [3,4]
C0205108
prior revascularization (percutaneous coronary intervention or coronary artery bypass surgery)
Beskrivning

Coronary revascularisation | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0877341
UMLS CUI [2]
C1532338
UMLS CUI [3]
C0010055
2. mi can be documented in the following ways:
Beskrivning

Myocardial Infarction criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0243161
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:
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0027051
UMLS CUI [1,2]
C0019993
UMLS CUI [2,1]
C2735102
UMLS CUI [2,2]
C1264641
UMLS CUI [3]
C0151576
UMLS CUI [4]
C1141948
UMLS CUI [5]
C0151744
symptoms of ischemia
Beskrivning

Symptoms Ischemia

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0022116
ecg changes indicative of new ischemia (new st-t changes or new lbbb)
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0855329
UMLS CUI [1,2]
C0392360
UMLS CUI [1,3]
C0022116
UMLS CUI [1,4]
C0205314
UMLS CUI [2,1]
C0919620
UMLS CUI [2,2]
C0205314
UMLS CUI [3,1]
C0344420
UMLS CUI [3,2]
C0205314
development of pathological q waves
Beskrivning

Q waves Pathological

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1305738
UMLS CUI [1,2]
C1521733
imaging evidence of new loss of viable myocardium or new regional wall motion abnormality
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C3898142
UMLS CUI [2,1]
C2024793
UMLS CUI [2,2]
C0205147
UMLS CUI [2,3]
C0205314
if no report from the mi hospitalization is available, prior mi can be met by either of the following:
Beskrivning

Prior myocardial infarction criteria

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0155668
UMLS CUI [1,2]
C0243161
development of pathological q waves
Beskrivning

Q waves Pathological

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1305738
UMLS CUI [1,2]
C1521733
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
Beskrivning

Loss of Viable Myocardium Imaging regional

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3898142
UMLS CUI [1,2]
C0205147
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
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).
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0018790
UMLS CUI [2]
C3272259
UMLS CUI [3,1]
C0750197
UMLS CUI [3,2]
C0205263
2. unexplained syncope
Beskrivning

Syncope Unknown

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0039070
UMLS CUI [1,2]
C0439673
3. current or planned implantable cardiac defibrillator (icd)
Beskrivning

Implantable defibrillator | Implantable defibrillator Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0162589
UMLS CUI [2,1]
C0162589
UMLS CUI [2,2]
C1301732
4. any condition other than cardiac disease that, in the investigator's judgment, would seriously limit life expectancy (poor survival)
Beskrivning

Condition Life Expectancy Limited Serious | Exception Heart Disease

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0023671
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0205404
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
5. metastatic cancer
Beskrivning

Neoplasm Metastasis

Datatyp

boolean

Alias
UMLS CUI [1]
C0027627
6. marked valvular heart disease requiring surgical intervention
Beskrivning

Heart valve disease Marked Requirement Operative Surgical Procedures

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018824
UMLS CUI [1,2]
C1706089
UMLS CUI [1,3]
C1514873
UMLS CUI [1,4]
C0543467
7. current or planned cardiac, renal or liver transplant
Beskrivning

Heart Transplantation | Kidney Transplantation | Transplantation of liver | Heart Transplantation Planned | Kidney Transplantation Planned | Transplantation of liver Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0018823
UMLS CUI [2]
C0022671
UMLS CUI [3]
C0023911
UMLS CUI [4,1]
C0018823
UMLS CUI [4,2]
C1301732
UMLS CUI [5,1]
C0022671
UMLS CUI [5,2]
C1301732
UMLS CUI [6,1]
C0023911
UMLS CUI [6,2]
C1301732
8. current alcohol or drug abuse
Beskrivning

Substance Use Disorders

Datatyp

boolean

Alias
UMLS CUI [1]
C0038586
9. unwilling or unable to provide informed consent
Beskrivning

Informed Consent Unwilling | Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0558080
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1299582
10. lvef <35% with class ii-iii chf or lvef <30%
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2,1]
C0018802
UMLS CUI [2,2]
C1275491
11. participation in a clinical trial where the active treatment arm is testing an agent and/or intervention with known antiarrhythmic properties
Beskrivning

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

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0003195
UMLS CUI [3,1]
C0184661
UMLS CUI [3,2]
C0521124
UMLS CUI [3,3]
C0003811
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Similar models

Eligibility Coronary Artery Disease NCT01114269

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
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])
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])
Heart Transplantation | Kidney Transplantation | Transplantation of liver | Heart Transplantation Planned | Kidney Transplantation Planned | Transplantation of liver Planned
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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