ID

28721

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT01114269

Trefwoorden

Versies (1)
  1. 28-01-18 28-01-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

28 januari 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Coronary Artery Disease NCT01114269

Engels

Eligibility Coronary Artery Disease NCT01114269

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

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

Coronary Artery Disease | Prior myocardial infarction

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

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

Datatype

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
Beschrijving

Age

Datatype

boolean

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

Coronary Artery Disease Criteria Quantity

Datatype

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
Beschrijving

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

Datatype

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)
Beschrijving

Coronary revascularisation | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

Datatype

boolean

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

Myocardial Infarction criteria

Datatype

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:
Beschrijving

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

Datatype

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
Beschrijving

Symptoms Ischemia

Datatype

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)
Beschrijving

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

Datatype

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
Beschrijving

Q waves Pathological

Datatype

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
Beschrijving

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

Datatype

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:
Beschrijving

Prior myocardial infarction criteria

Datatype

boolean

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

Q waves Pathological

Datatype

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
Beschrijving

Loss of Viable Myocardium Imaging regional

Datatype

boolean

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

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).
Beschrijving

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

Datatype

boolean

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

Syncope Unknown

Datatype

boolean

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

Implantable defibrillator | Implantable defibrillator Planned

Datatype

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)
Beschrijving

Condition Life Expectancy Limited Serious | Exception Heart Disease

Datatype

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
Beschrijving

Neoplasm Metastasis

Datatype

boolean

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

Heart valve disease Marked Requirement Operative Surgical Procedures

Datatype

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
Beschrijving

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

Datatype

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
Beschrijving

Substance Use Disorders

Datatype

boolean

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

Informed Consent Unwilling | Informed Consent Unable

Datatype

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%
Beschrijving

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

Datatype

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
Beschrijving

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

Datatype

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
Terug naar het begin van de pagina

Similar models

Eligibility Coronary Artery Disease NCT01114269

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial