ID

13620

Description

The Stent or Surgery (SoS) Trial; ODM derived from: https://clinicaltrials.gov/show/NCT00475449

Link

https://clinicaltrials.gov/show/NCT00475449

Keywords

Versions (1)
  1. 2/20/16 2/20/16 -
Uploaded on

February 20, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00475449

English

Eligibility Coronary Artery Disease NCT00475449

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
written informed consent.
Description

written informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
patient has typical angina pectoris - stable or unstable symptoms.
Description

angina pectoris

Data type

boolean

Alias
UMLS CUI [1]
C0002962
atherosclerotic coronary artery disease demonstrated with selective coronary angiography with a significant lesion present in at least two of the principal epicardial vessel systems.
Description

atherosclerotic coronary artery disease

Data type

boolean

Alias
UMLS CUI [1]
C0010054
revascularisation procedure clinically indicated.
Description

revascularisation indicated

Data type

boolean

Alias
UMLS CUI [1,1]
C0581603
UMLS CUI [1,2]
C1444656
nominated trial surgeon accepts the patient for cabg.
Description

cabg

Data type

boolean

Alias
UMLS CUI [1,1]
C0010055
UMLS CUI [1,2]
C1444656
nominated trial interventionist accepts the patient for ptca and stent.
Description

ptca and stent indicated

Data type

boolean

Alias
UMLS CUI [1,1]
C2936173
UMLS CUI [1,2]
C1444656
at least one identified lesion suitable and targeted for primary stent implantation.
Description

stent indicated

Data type

boolean

Alias
UMLS CUI [1,1]
C0038257
UMLS CUI [1,2]
C1444656
a procedure for the completion of either revascularisation strategy can be performed within 6 weeks of randomisation.
Description

revascularisation strategy can be performed within 6 weeks of randomisation

Data type

boolean

Alias
UMLS CUI [1]
C1321605
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
previous cabg procedure or other thoracotomy.
Description

previous cabg procedure or other thoracotomy

Data type

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2]
C0039991
previous coronary interventional procedure (of any type).
Description

previous coronary intervention

Data type

boolean

Alias
UMLS CUI [1]
C1532338
intervention on any cardiac valve scheduled for the index revascularisation procedure.
Description

intervention on cardiac valve scheduled for revascularisation procedure

Data type

boolean

Alias
UMLS CUI [1]
C3274795
excision or other intervention on the myocardium scheduled for the index revascularisation procedure.
Description

intervention on the myocardium scheduled for the revascularisation procedure

Data type

boolean

Alias
UMLS CUI [1]
C0027061
intervention on the great vessels, carotid arteries or aorta scheduled for the index revascularisation procedure.
Description

intervention on the great vessels scheduled for the revascularisation procedure

Data type

boolean

Alias
UMLS CUI [1]
C1292969
absent autologous graft material.
Description

absent autograft material

Data type

boolean

Alias
UMLS CUI [1]
C0559189
non-cardiac disease influencing survival.
Description

disease influencing survival

Data type

boolean

Alias
UMLS CUI [1]
C0009488
acute myocardial infarction in the 48 hours preceding the proposed revascularisation procedure.
Description

acute myocardial infarction

Data type

boolean

Alias
UMLS CUI [1]
C0155626
participation in any other study that would involve deviation from the routine local management of a revascularisation procedure.
Description

participation in any other study

Data type

boolean

Alias
UMLS CUI [1]
C2348568
allergy to anti-platelet agents in local use.
Description

allergy to locally used anti-platelet agents

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C2963157
language or other communication barrier.
Description

communication barriers

Data type

boolean

Alias
UMLS CUI [1]
C1321605
follow-up for two years not possible / patient unreliable.
Description

follow up limited

Data type

boolean

Alias
UMLS CUI [1]
C1321605
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Similar models

Eligibility Coronary Artery Disease NCT00475449

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
written informed consent
Item
written informed consent.
boolean
C0021430 (UMLS CUI [1])
angina pectoris
Item
patient has typical angina pectoris - stable or unstable symptoms.
boolean
C0002962 (UMLS CUI [1])
atherosclerotic coronary artery disease
Item
atherosclerotic coronary artery disease demonstrated with selective coronary angiography with a significant lesion present in at least two of the principal epicardial vessel systems.
boolean
C0010054 (UMLS CUI [1])
revascularisation indicated
Item
revascularisation procedure clinically indicated.
boolean
C0581603 (UMLS CUI [1,1])
C1444656 (UMLS CUI [1,2])
cabg
Item
nominated trial surgeon accepts the patient for cabg.
boolean
C0010055 (UMLS CUI [1,1])
C1444656 (UMLS CUI [1,2])
ptca and stent indicated
Item
nominated trial interventionist accepts the patient for ptca and stent.
boolean
C2936173 (UMLS CUI [1,1])
C1444656 (UMLS CUI [1,2])
stent indicated
Item
at least one identified lesion suitable and targeted for primary stent implantation.
boolean
C0038257 (UMLS CUI [1,1])
C1444656 (UMLS CUI [1,2])
revascularisation strategy can be performed within 6 weeks of randomisation
Item
a procedure for the completion of either revascularisation strategy can be performed within 6 weeks of randomisation.
boolean
C1321605 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
previous cabg procedure or other thoracotomy
Item
previous cabg procedure or other thoracotomy.
boolean
C0010055 (UMLS CUI [1])
C0039991 (UMLS CUI [2])
previous coronary intervention
Item
previous coronary interventional procedure (of any type).
boolean
C1532338 (UMLS CUI [1])
intervention on cardiac valve scheduled for revascularisation procedure
Item
intervention on any cardiac valve scheduled for the index revascularisation procedure.
boolean
C3274795 (UMLS CUI [1])
intervention on the myocardium scheduled for the revascularisation procedure
Item
excision or other intervention on the myocardium scheduled for the index revascularisation procedure.
boolean
C0027061 (UMLS CUI [1])
intervention on the great vessels scheduled for the revascularisation procedure
Item
intervention on the great vessels, carotid arteries or aorta scheduled for the index revascularisation procedure.
boolean
C1292969 (UMLS CUI [1])
absent autograft material
Item
absent autologous graft material.
boolean
C0559189 (UMLS CUI [1])
disease influencing survival
Item
non-cardiac disease influencing survival.
boolean
C0009488 (UMLS CUI [1])
acute myocardial infarction
Item
acute myocardial infarction in the 48 hours preceding the proposed revascularisation procedure.
boolean
C0155626 (UMLS CUI [1])
participation in any other study
Item
participation in any other study that would involve deviation from the routine local management of a revascularisation procedure.
boolean
C2348568 (UMLS CUI [1])
allergy to locally used anti-platelet agents
Item
allergy to anti-platelet agents in local use.
boolean
C0020517 (UMLS CUI [1,1])
C2963157 (UMLS CUI [1,2])
communication barriers
Item
language or other communication barrier.
boolean
C1321605 (UMLS CUI [1])
follow up limited
Item
follow-up for two years not possible / patient unreliable.
boolean
C1321605 (UMLS CUI [1])
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