German Off Pump Coronary Artery Bypass in Elderly Study

Phase 3

Completed

• Conditions: Heart Disease

• Registration Number: NCT00719667
• Lead Sponsor: German Off Pump Coronary Artery Bypass in Elderly Study Group

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-20
• Study First Submitted QC: 2008-07-21
• Study First Posted: 2008-07-22
• Status Verified: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2011-10-17
• Last Update Posted: 2011-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2000

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
All cause mortality	1 month and 12 month
Myocardial infarction	1 month and 12 month
Stroke	1 month and 12 month
Any revascularisation	1 month and30 month
renal failure	1 month and 12 month

Secondary Outcome Measures

Name	Time	Method
ventilation time	post op
blood transfusion	post op
length of stay in intensive-care unit	post op

Trial Locations

Locations (2)

Herzchirurgie Neustadt/Saale; 🇩🇪 Neustadt/Saale, Bayern, Germany

Universität Regensburg; 🇩🇪 Regensburg, Bayern, Germany