ID

23485

Beschreibung

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

Stichworte

Versionen (1)
  1. 07.07.17 07.07.17 -
Hochgeladen am

7. Juli 2017

DOI

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Creative Commons BY 4.0
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Eligibility Coronary Artery Bypass NCT01715714 DRKS00000753

Englisch

Eligibility Coronary Artery Bypass NCT01715714 DRKS00000753

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI-1
C1512693
1. Patients on chronic statin treatment (>30 days) scheduled for isolated CABG, including on- or off-pump or repeat (redo's) revascularisation procedures
Beschreibung

Statin Treatment, Coronary Artery Bypass Surgery

Datentyp

boolean

Alias
UMLS CUI [1]
C1314135
UMLS CUI [2]
C0010055
2. Stable or unstable angina, including non ST-segment-elevation acute coronary syndrome (NSTE-ACS)
Beschreibung

Angina

Datentyp

boolean

Alias
UMLS CUI [1]
C0002962
3. Age ≥ 18 years
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
4. Written informed consent
Beschreibung

Informed Consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI-1
C0680251
0. Healthy Volunteers
Beschreibung

Control Group

Datentyp

boolean

Alias
UMLS CUI [1]
C0009932
1. Any concomitant cardiovascular procedure to CABG (i.e. valve, aortic or carotid surgery)
Beschreibung

Cardiovascular procedure

Datentyp

boolean

Alias
UMLS CUI [1]
C0189573
2. Acute ST-segment-elevation myocardial infarction (STEMI)
Beschreibung

STEMI

Datentyp

boolean

Alias
UMLS CUI [1]
C1536220
3. NSTE-ACS with cardiogenic shock warranting emergent salvage surgery within 12 hrs from hospital admission
Beschreibung

NSTE-ACS

Datentyp

boolean

Alias
UMLS CUI [1,1]
C4255010
UMLS CUI [1,2]
C0948089
4. History of atrial fibrillation or muscle disease (myopathy)
Beschreibung

Atrial fibrillation, Myopathy

Datentyp

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C0026848
5. Current renal (creatinine>2x upper limit of normal (ULN), dialysis, kidney transplant) or hepatic dysfunction (AST/ALT>2x ULN, liver transplant or neoplasm)
Beschreibung

Renal or Hepatic Function

Datentyp

boolean

Alias
UMLS CUI [1]
C0232804
UMLS CUI [2]
C0232741
6. Inability of oral drug intake
Beschreibung

Drug intake

Datentyp

boolean

Alias
UMLS CUI [1]
C0420252
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Ähnliche Modelle

Eligibility Coronary Artery Bypass NCT01715714 DRKS00000753

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
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])
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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