ID

14096

Description

Coronary Bypass Surgery Trial: Complete Arterial Revascularization and Conventional Coronary Artery Surgery; ODM derived from: https://clinicaltrials.gov/show/NCT00317265

Lien

https://clinicaltrials.gov/show/NCT00317265

Mots-clés

Versions (1)
  1. 29/03/2016 29/03/2016 -
Téléchargé le

29 mars 2016

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
Modèle Commentaires :

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Eligibility Coronary Artery Disease NCT00317265

Anglais

Eligibility Coronary Artery Disease NCT00317265

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patient eligible for surgical myocardial revascularization
Description

Eligible for myocardial revascularization

Type de données

boolean

Alias
UMLS CUI [1,1]
C0027056
UMLS CUI [1,2]
C0013893
2. age 70 years or less
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
3. triple vessel coronary disease with significant coronary artery stenosis defined as a stenosis of at least 50% in luminal diameter
Description

Triple vessel coronary disease with coronary artery stenosis

Type de données

boolean

Alias
UMLS CUI [1,1]
C0340285
UMLS CUI [1,2]
C0242231
4. patients with stable angina pectoris (canadian cardiovascular society 1, 2, 3, or 4) or unstable angina pectoris (braunwald classification 1b, 2b, 3b) or proven silent myocardial ischemia.
Description

Angina pectoris or myocardial ischemia

Type de données

boolean

Alias
UMLS CUI [1]
C1879987
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0340291
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. no informed consent
Description

Informed consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
2. age > 65 years
Description

ID.6

Type de données

boolean

3. participation in another study with any investigational drug or coronary revascularization procedure
Description

Participation status

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
4. when follow up over a period of five years is difficult or unlikely
Description

Follow up

Type de données

boolean

Alias
UMLS CUI [1]
C1522577
5. concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer)
Description

Prognosis limited by comorbidity

Type de données

boolean

Alias
UMLS CUI [1,1]
C0033325
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0009488
6. one or two vessel coronary disease and isolated left main stenosis
Description

Coronary artery disease specification

Type de données

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C2348235
7. estimated left ventricular ejection fraction < 25%
Description

Left ventricular ejection fraction

Type de données

boolean

Alias
UMLS CUI [1]
C0428772
8. myocardial infarction within seven days
Description

Acute myocardial infarction

Type de données

boolean

Alias
UMLS CUI [1]
C0155626
9. need for concomitant major cardiac or non-cardiac surgery (e.g. valve surgery, left ventricular aneurysm, aortic aneurysm, carotid artery desobliteration, etc.)
Description

Major cardiac or non-cardiac surgery

Type de données

boolean

Alias
UMLS CUI [1]
C0018821
UMLS CUI [2]
C0679637
10. redo-cardiac surgery
Description

Redo-cardiac surgery

Type de données

boolean

Alias
UMLS CUI [1,1]
C0439617
UMLS CUI [1,2]
C0018821
11. presence of the combination of insulin dependent diabetes mellitus and chronic obstructive pulmonary disease requiring therapy
Description

Insulin dependent diabetes mellitus and COPD

Type de données

boolean

Alias
UMLS CUI [1,1]
C0011854
UMLS CUI [1,2]
C0024117
12. renal insufficiency requiring dialysis
Description

Dialysis

Type de données

boolean

Alias
UMLS CUI [1]
C0011946
13. presence of the combination of severe adiposity and insulin dependent diabetes mellitus
Description

Severe adiposity and insulin dependent diabetes mellitus

Type de données

boolean

Alias
UMLS CUI [1,1]
C0028756
UMLS CUI [1,2]
C0011854
14. presence of the combination of severe adiposity and chronic obstructive pulmonary disease requiring therapy
Description

Severe adiposity and chronic obstructive pulmonary disease

Type de données

boolean

Alias
UMLS CUI [1,1]
C0028756
UMLS CUI [1,2]
C0024117
15. severe hepatic disease
Description

Hepatic disease

Type de données

boolean

Alias
UMLS CUI [1]
C0023895
16. emergent operation for coronary artery disease with signs of ischemia (e.g. failed ptca, ongoing myocardial infarction)
Description

Emergent operation for coronary artery disease with signs of ischemia

Type de données

boolean

Alias
UMLS CUI [1,1]
C0184893
UMLS CUI [1,2]
C1956346
UMLS CUI [1,3]
C0151744
17. unstable angina pectoris class a and c according to braunwald classification (i.e. secondary unstable angina and postinfarction unstable angina within one week after acute mi)
Description

secondary and postinfarction unstable angina

Type de données

boolean

Alias
UMLS CUI [1,1]
C0002965
UMLS CUI [1,2]
C0175668
UMLS CUI [2,1]
C0002965
UMLS CUI [2,2]
C1142492
18. inadequate quality of saphenous vein material
Description

Saphenous vein qualitiy

Type de données

boolean

Alias
UMLS CUI [1,1]
C0036186
UMLS CUI [1,2]
C0036186
19. inadequate quality or number of arterial conduits to achieve complete revascularization likely (e.g. chest irradiation, major abdominal surgery)
Description

Coronary artery quality

Type de données

boolean

Alias
UMLS CUI [1,1]
C0205042
UMLS CUI [1,2]
C0332306
20. recent (< 2weeks) cerebrovascular event (tia, rind, stroke)
Description

Cerebrovascular event

Type de données

boolean

Alias
UMLS CUI [1]
C0038454
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Similar models

Eligibility Coronary Artery Disease NCT00317265

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Eligible for myocardial revascularization
Item
1. patient eligible for surgical myocardial revascularization
boolean
C0027056 (UMLS CUI [1,1])
C0013893 (UMLS CUI [1,2])
Age
Item
2. age 70 years or less
boolean
C0001779 (UMLS CUI [1])
Triple vessel coronary disease with coronary artery stenosis
Item
3. triple vessel coronary disease with significant coronary artery stenosis defined as a stenosis of at least 50% in luminal diameter
boolean
C0340285 (UMLS CUI [1,1])
C0242231 (UMLS CUI [1,2])
Angina pectoris or myocardial ischemia
Item
4. patients with stable angina pectoris (canadian cardiovascular society 1, 2, 3, or 4) or unstable angina pectoris (braunwald classification 1b, 2b, 3b) or proven silent myocardial ischemia.
boolean
C1879987 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0340291 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Informed consent
Item
1. no informed consent
boolean
C0021430 (UMLS CUI [1])
ID.6
Item
2. age > 65 years
boolean
Participation status
Item
3. participation in another study with any investigational drug or coronary revascularization procedure
boolean
C2348568 (UMLS CUI [1])
Follow up
Item
4. when follow up over a period of five years is difficult or unlikely
boolean
C1522577 (UMLS CUI [1])
Prognosis limited by comorbidity
Item
5. concomitant non-cardiac disease likely to limit long-term prognosis (e.g. cancer)
boolean
C0033325 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
Coronary artery disease specification
Item
6. one or two vessel coronary disease and isolated left main stenosis
boolean
C1956346 (UMLS CUI [1,1])
C2348235 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
7. estimated left ventricular ejection fraction < 25%
boolean
C0428772 (UMLS CUI [1])
Acute myocardial infarction
Item
8. myocardial infarction within seven days
boolean
C0155626 (UMLS CUI [1])
Major cardiac or non-cardiac surgery
Item
9. need for concomitant major cardiac or non-cardiac surgery (e.g. valve surgery, left ventricular aneurysm, aortic aneurysm, carotid artery desobliteration, etc.)
boolean
C0018821 (UMLS CUI [1])
C0679637 (UMLS CUI [2])
Redo-cardiac surgery
Item
10. redo-cardiac surgery
boolean
C0439617 (UMLS CUI [1,1])
C0018821 (UMLS CUI [1,2])
Insulin dependent diabetes mellitus and COPD
Item
11. presence of the combination of insulin dependent diabetes mellitus and chronic obstructive pulmonary disease requiring therapy
boolean
C0011854 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
Dialysis
Item
12. renal insufficiency requiring dialysis
boolean
C0011946 (UMLS CUI [1])
Severe adiposity and insulin dependent diabetes mellitus
Item
13. presence of the combination of severe adiposity and insulin dependent diabetes mellitus
boolean
C0028756 (UMLS CUI [1,1])
C0011854 (UMLS CUI [1,2])
Severe adiposity and chronic obstructive pulmonary disease
Item
14. presence of the combination of severe adiposity and chronic obstructive pulmonary disease requiring therapy
boolean
C0028756 (UMLS CUI [1,1])
C0024117 (UMLS CUI [1,2])
Hepatic disease
Item
15. severe hepatic disease
boolean
C0023895 (UMLS CUI [1])
Emergent operation for coronary artery disease with signs of ischemia
Item
16. emergent operation for coronary artery disease with signs of ischemia (e.g. failed ptca, ongoing myocardial infarction)
boolean
C0184893 (UMLS CUI [1,1])
C1956346 (UMLS CUI [1,2])
C0151744 (UMLS CUI [1,3])
secondary and postinfarction unstable angina
Item
17. unstable angina pectoris class a and c according to braunwald classification (i.e. secondary unstable angina and postinfarction unstable angina within one week after acute mi)
boolean
C0002965 (UMLS CUI [1,1])
C0175668 (UMLS CUI [1,2])
C0002965 (UMLS CUI [2,1])
C1142492 (UMLS CUI [2,2])
Saphenous vein qualitiy
Item
18. inadequate quality of saphenous vein material
boolean
C0036186 (UMLS CUI [1,1])
C0036186 (UMLS CUI [1,2])
Coronary artery quality
Item
19. inadequate quality or number of arterial conduits to achieve complete revascularization likely (e.g. chest irradiation, major abdominal surgery)
boolean
C0205042 (UMLS CUI [1,1])
C0332306 (UMLS CUI [1,2])
Cerebrovascular event
Item
20. recent (< 2weeks) cerebrovascular event (tia, rind, stroke)
boolean
C0038454 (UMLS CUI [1])
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