ID

27582

Beskrivning

Women's Ischemia Syndrome Evaluation (WISE) Coronary Vascular Dysfunction; ODM derived from: https://clinicaltrials.gov/show/NCT00832702

Länk

https://clinicaltrials.gov/show/NCT00832702

Nyckelord

Versioner (1)
  1. 2017-11-21 2017-11-21 -
Rättsinnehavare

See clinicaltrials.gov

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21 november 2017

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Cardiovascular Disease NCT00832702

Engelsk

Eligibility Cardiovascular Disease NCT00832702

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. symptomatic angina or anginal equivalent;
Beskrivning

Angina Pectoris Symptomatic | Anginal equivalent

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0002962
UMLS CUI [1,2]
C0231220
UMLS CUI [2]
C0741034
2. aged 18 years or older;
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
3. no obstructive cad at coronary angiography (performed within the previous 24 months).
Beskrivning

Coronary Artery Disease Obstructive Absent Coronary angiography

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0549186
UMLS CUI [1,3]
C0332197
UMLS CUI [1,4]
C0085532
4. competent to give informed consent.
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. obstructive cad ≥ 50% luminal diameter stenosis in ≥ 1 epicardial coronary artery,
Beskrivning

Coronary Artery Disease Obstructive | Stenosis Diameter Luminal Percentage | Coronary artery Epicardial Quantity

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0549186
UMLS CUI [2,1]
C1261287
UMLS CUI [2,2]
C1301886
UMLS CUI [2,3]
C0524462
UMLS CUI [2,4]
C0439165
UMLS CUI [3,1]
C0205042
UMLS CUI [3,2]
C0442016
UMLS CUI [3,3]
C1265611
2. acute coronary syndrome (defined by the acc/aha criteria, braunwald 2000),
Beskrivning

Acute Coronary Syndrome

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
3. primary valvular heart disease clearly indicating the need for valve repair or replacement;
Beskrivning

Primary valvular heart disease | Repair of heart valve Patient need for | Heart valve replacement Patient need for

Datatyp

boolean

Alias
UMLS CUI [1]
C2064629
UMLS CUI [2,1]
C0190112
UMLS CUI [2,2]
C0686904
UMLS CUI [3,1]
C0190173
UMLS CUI [3,2]
C0686904
4. patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support;
Beskrivning

Shock, Cardiogenic | Inotropic agent Patient need for | Intra-Aortic Balloon Pumping Patient need for

Datatyp

boolean

Alias
UMLS CUI [1]
C0036980
UMLS CUI [2,1]
C0304509
UMLS CUI [2,2]
C0686904
UMLS CUI [3,1]
C0021860
UMLS CUI [3,2]
C0686904
5. prior or planned percutaneous coronary intervention or cabg,
Beskrivning

Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention Planned | Coronary Artery Bypass Surgery Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C1532338
UMLS CUI [2]
C0010055
UMLS CUI [3,1]
C1532338
UMLS CUI [3,2]
C1301732
UMLS CUI [4,1]
C0010055
UMLS CUI [4,2]
C1301732
6. acute mi;
Beskrivning

Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
7. prior non-cardiac illness with an estimated life expectancy < 4 years;
Beskrivning

Illness | Exception Heart Diseases | Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0221423
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
UMLS CUI [3]
C0023671
8. unable to give informed consent;
Beskrivning

Informed Consent Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
9. chest pain with a non-ischemic etiology (e.g.,pericarditis, pneumonia, esophageal spasm);
Beskrivning

Chest Pain Without Etiology Ischemic | Pericarditis | Pneumonia | Esophageal spasm

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0008031
UMLS CUI [1,2]
C0332288
UMLS CUI [1,3]
C0015127
UMLS CUI [1,4]
C0475224
UMLS CUI [2]
C0031046
UMLS CUI [3]
C0032285
UMLS CUI [4]
C0014863
10. contraindications to cmri (e.g., aicd, pacemaker, untreatable claustrophobia or known angio-edema).
Beskrivning

Medical contraindication MRI | Automatic Implantable Cardioverter-Defibrillators | Artificial cardiac pacemaker | Claustrophobia Treating Unsuccessful | Angioedema

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2]
C0972395
UMLS CUI [3]
C0030163
UMLS CUI [4,1]
C0008909
UMLS CUI [4,2]
C1522326
UMLS CUI [4,3]
C1272705
UMLS CUI [5]
C0002994
11. contraindications to adenosine or regadenoson (lexiscan)
Beskrivning

Medical contraindication Adenosine | Medical contraindication regadenoson | Medical contraindication Lexiscan

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0001443
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C1698215
UMLS CUI [3,1]
C1301624
UMLS CUI [3,2]
C2343930
12. women with intermediate coronary stenoses (> 20% but < 50% luminal diameter stenosis assessed visually at the time of angiography) will undergo clinically indicated ivus testing based on the judgment of the operator; those determined to have flow-obstructing stenosis will be excluded from the overall study.
Beskrivning

Gender | Coronary Stenosis Intermediate | Stenosis Diameter Luminal Percentage | Angiography | Indication IVUS Imaging | Stenosis Obstructive

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0242231
UMLS CUI [2,2]
C0205103
UMLS CUI [3,1]
C1261287
UMLS CUI [3,2]
C1301886
UMLS CUI [3,3]
C0524462
UMLS CUI [3,4]
C0439165
UMLS CUI [4]
C0002978
UMLS CUI [5,1]
C3146298
UMLS CUI [5,2]
C0183133
UMLS CUI [6,1]
C1261287
UMLS CUI [6,2]
C0549186
13. participation in a research study that conflicts with the current wise study.
Beskrivning

Study Subject Participation Status Interferes with Clinical Trial Current

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0008976
UMLS CUI [1,4]
C0521116
14. women with coronary stenosis ≥ 50% in any epicardial coronary artery, assessed visually at the time of angiography, will not be included in the crt subgroup.
Beskrivning

Gender | Coronary Stenosis Percentage Coronary artery Epicardial | Angiography

Datatyp

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2,1]
C0242231
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0205042
UMLS CUI [2,4]
C0442016
UMLS CUI [3]
C0002978
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Similar models

Eligibility Cardiovascular Disease NCT00832702

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Angina Pectoris Symptomatic | Anginal equivalent
Item
1. symptomatic angina or anginal equivalent;
boolean
C0002962 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0741034 (UMLS CUI [2])
Age
Item
2. aged 18 years or older;
boolean
C0001779 (UMLS CUI [1])
Coronary Artery Disease Obstructive Absent Coronary angiography
Item
3. no obstructive cad at coronary angiography (performed within the previous 24 months).
boolean
C1956346 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0332197 (UMLS CUI [1,3])
C0085532 (UMLS CUI [1,4])
Informed Consent
Item
4. competent to give informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Coronary Artery Disease Obstructive | Stenosis Diameter Luminal Percentage | Coronary artery Epicardial Quantity
Item
1. obstructive cad ≥ 50% luminal diameter stenosis in ≥ 1 epicardial coronary artery,
boolean
C1956346 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C1261287 (UMLS CUI [2,1])
C1301886 (UMLS CUI [2,2])
C0524462 (UMLS CUI [2,3])
C0439165 (UMLS CUI [2,4])
C0205042 (UMLS CUI [3,1])
C0442016 (UMLS CUI [3,2])
C1265611 (UMLS CUI [3,3])
Acute Coronary Syndrome
Item
2. acute coronary syndrome (defined by the acc/aha criteria, braunwald 2000),
boolean
C0948089 (UMLS CUI [1])
Primary valvular heart disease | Repair of heart valve Patient need for | Heart valve replacement Patient need for
Item
3. primary valvular heart disease clearly indicating the need for valve repair or replacement;
boolean
C2064629 (UMLS CUI [1])
C0190112 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0190173 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Shock, Cardiogenic | Inotropic agent Patient need for | Intra-Aortic Balloon Pumping Patient need for
Item
4. patients with concurrent cardiogenic shock or requiring inotropic or intra-aortic balloon support;
boolean
C0036980 (UMLS CUI [1])
C0304509 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0021860 (UMLS CUI [3,1])
C0686904 (UMLS CUI [3,2])
Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention Planned | Coronary Artery Bypass Surgery Planned
Item
5. prior or planned percutaneous coronary intervention or cabg,
boolean
C1532338 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C1532338 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
C0010055 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
Myocardial Infarction
Item
6. acute mi;
boolean
C0027051 (UMLS CUI [1])
Illness | Exception Heart Diseases | Life Expectancy
Item
7. prior non-cardiac illness with an estimated life expectancy < 4 years;
boolean
C0221423 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
C0023671 (UMLS CUI [3])
Informed Consent Unable
Item
8. unable to give informed consent;
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Chest Pain Without Etiology Ischemic | Pericarditis | Pneumonia | Esophageal spasm
Item
9. chest pain with a non-ischemic etiology (e.g.,pericarditis, pneumonia, esophageal spasm);
boolean
C0008031 (UMLS CUI [1,1])
C0332288 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0475224 (UMLS CUI [1,4])
C0031046 (UMLS CUI [2])
C0032285 (UMLS CUI [3])
C0014863 (UMLS CUI [4])
Medical contraindication MRI | Automatic Implantable Cardioverter-Defibrillators | Artificial cardiac pacemaker | Claustrophobia Treating Unsuccessful | Angioedema
Item
10. contraindications to cmri (e.g., aicd, pacemaker, untreatable claustrophobia or known angio-edema).
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C0972395 (UMLS CUI [2])
C0030163 (UMLS CUI [3])
C0008909 (UMLS CUI [4,1])
C1522326 (UMLS CUI [4,2])
C1272705 (UMLS CUI [4,3])
C0002994 (UMLS CUI [5])
Medical contraindication Adenosine | Medical contraindication regadenoson | Medical contraindication Lexiscan
Item
11. contraindications to adenosine or regadenoson (lexiscan)
boolean
C1301624 (UMLS CUI [1,1])
C0001443 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C1698215 (UMLS CUI [2,2])
C1301624 (UMLS CUI [3,1])
C2343930 (UMLS CUI [3,2])
Gender | Coronary Stenosis Intermediate | Stenosis Diameter Luminal Percentage | Angiography | Indication IVUS Imaging | Stenosis Obstructive
Item
12. women with intermediate coronary stenoses (> 20% but < 50% luminal diameter stenosis assessed visually at the time of angiography) will undergo clinically indicated ivus testing based on the judgment of the operator; those determined to have flow-obstructing stenosis will be excluded from the overall study.
boolean
C0079399 (UMLS CUI [1])
C0242231 (UMLS CUI [2,1])
C0205103 (UMLS CUI [2,2])
C1261287 (UMLS CUI [3,1])
C1301886 (UMLS CUI [3,2])
C0524462 (UMLS CUI [3,3])
C0439165 (UMLS CUI [3,4])
C0002978 (UMLS CUI [4])
C3146298 (UMLS CUI [5,1])
C0183133 (UMLS CUI [5,2])
C1261287 (UMLS CUI [6,1])
C0549186 (UMLS CUI [6,2])
Study Subject Participation Status Interferes with Clinical Trial Current
Item
13. participation in a research study that conflicts with the current wise study.
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0521116 (UMLS CUI [1,4])
Gender | Coronary Stenosis Percentage Coronary artery Epicardial | Angiography
Item
14. women with coronary stenosis ≥ 50% in any epicardial coronary artery, assessed visually at the time of angiography, will not be included in the crt subgroup.
boolean
C0079399 (UMLS CUI [1])
C0242231 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0205042 (UMLS CUI [2,3])
C0442016 (UMLS CUI [2,4])
C0002978 (UMLS CUI [3])
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