German Off Pump Coronary Artery Bypass in Elderly Study

Heart Disease Clinical Trial

— GOPCABE  

Official title:

German Off Pump Coronary Artery Bypass in Elderly Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00719667
• Other study ID #: op 001
• Status: Completed
• Phase: Phase 3
• First received: July 20, 2008
• Last updated: October 17, 2011
• Start date: July 2008
• Est. completion date: October 2011

Study information

• Verified date: October 2011
• Source: German Off Pump Coronary Artery Bypass in Elderly Study Group
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

Comparison of two operative techniques (on-pump vs off-pump)of coronary revascularisation of the best treatment concept for patients older or 75 years old.

Hypothesis: The coronary bypass operation without use of the heart-lung machine (off-pump=OPCAB) reduces the combined endpoint in comparison with the conventional coronary bypass operation (on-pump).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• older or 75 years

• indication for elective bypass operation

• patient has signed written consent before randomization

Exclusion Criteria:

• previous heart surgery

• patient unable to give informed consent

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Disease

Intervention

Other:
• coronary artery bypass grafting
on pump off pump

Locations

Country	Name	City	State
Germany	Herzchirurgie Neustadt/Saale	Neustadt/Saale	Bayern
Germany	Universität Regensburg	Regensburg	Bayern

Sponsors (3)

Lead Sponsor	Collaborator
German Off Pump Coronary Artery Bypass in Elderly Study Group	Deutsche Gesellschaft für Herz-, Thorax- und Gefäßchirurgie, Institut für Klinisch-Kardiovaskuläre Forschung GmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality		1 month and 12 month	Yes
Primary	Myocardial infarction		1 month and 12 month	No
Primary	Stroke		1 month and 12 month	No
Primary	Any revascularisation		1 month and30 month	No
Primary	renal failure		1 month and 12 month	No
Secondary	ventilation time		post op	No
Secondary	blood transfusion		post op	No
Secondary	length of stay in intensive-care unit		post op	No