Eligibility Coronary Artery Bypass NCT01715714 DRKS00000753

ID

23485

Beschrijving

Responsible Party: PD Dr. Oliver J. Liakopoulos, Principal Investigator, University of Cologne ClinicalTrials.gov Identifier: NCT01715714 History of Changes Other Study ID Numbers: Uni-Koeln-1341 2011-001795-19 ( EudraCT Number ) DRKS00000753 ( Registry Identifier: German Clinical Trials Register (DRKS) ) Study First Received: October 18, 2012 Last Updated: May 11, 2016 Statin Recapture Therapy Before Coronary Artery Bypass Grafting (StaRT-CABG) ODM derived from: https://clinicaltrials.gov/ct2/show/NCT01715714

Link

https://clinicaltrials.gov/ct2/show/NCT01715714

Trefwoorden

07-07-17 07-07-17 -

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7 juli 2017

DOI

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Licentie

Creative Commons BY 4.0

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1 Formulieren

StudyEvent: ODM
1. Eligibility Coronary Artery Bypass NCT01715714 DRKS00000753

Name

Type

Description | Question | Decode (Coded Value)

Datatype

Alias

Inclusion Criteria

Item Group

Inclusion Criteria

C1512693 (UMLS CUI-1)

Statin Treatment, Coronary Artery Bypass Surgery

Item

1. Patients on chronic statin treatment (>30 days) scheduled for isolated CABG, including on- or off-pump or repeat (redo's) revascularisation procedures

boolean

C1314135 (UMLS CUI [1])
C0010055 (UMLS CUI [2])

Angina

Item

2. Stable or unstable angina, including non ST-segment-elevation acute coronary syndrome (NSTE-ACS)

boolean

C0002962 (UMLS CUI [1])

Age

Item

3. Age ≥ 18 years

boolean

C0001779 (UMLS CUI [1])

Informed Consent

Item

4. Written informed consent

boolean

C0021430 (UMLS CUI [1])

Exclusion Criteria

Item Group

Exclusion Criteria

C0680251 (UMLS CUI-1)

Control Group

Item

0. Healthy Volunteers

boolean

C0009932 (UMLS CUI [1])

Cardiovascular procedure

Item

1. Any concomitant cardiovascular procedure to CABG (i.e. valve, aortic or carotid surgery)

boolean

C0189573 (UMLS CUI [1])

STEMI

Item

2. Acute ST-segment-elevation myocardial infarction (STEMI)

boolean

C1536220 (UMLS CUI [1])

NSTE-ACS

Item

3. NSTE-ACS with cardiogenic shock warranting emergent salvage surgery within 12 hrs from hospital admission

boolean

C4255010 (UMLS CUI [1,1])
C0948089 (UMLS CUI [1,2])

Atrial fibrillation, Myopathy

Item

4. History of atrial fibrillation or muscle disease (myopathy)

boolean

C0004238 (UMLS CUI [1])
C0026848 (UMLS CUI [2])

Renal or Hepatic Function

Item

5. Current renal (creatinine>2x upper limit of normal (ULN), dialysis, kidney transplant) or hepatic dysfunction (AST/ALT>2x ULN, liver transplant or neoplasm)

boolean

C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])

Drug intake

Item

6. Inability of oral drug intake

boolean

C0420252 (UMLS CUI [1])

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Eligibility Coronary Artery Bypass NCT01715714 DRKS00000753