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Completed

NCT Number: NCT00719667

German Off Pump Coronary Artery Bypass in Elderly Study

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).

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Key information

Conditions

Heart Disease Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Herzchirurgie Neustadt/Saale, Neustadt/Saale, Bavaria, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

coronary artery bypass grafting

Other

on pump off pump

Primary outcomes

  1. All cause mortality

    Time frame: 1 month and 12 month

  2. Myocardial infarction

    Time frame: 1 month and 12 month

  3. Stroke

    Time frame: 1 month and 12 month

  4. Any revascularisation

    Time frame: 1 month and30 month

  5. renal failure

    Time frame: 1 month and 12 month

Secondary outcomes

  1. ventilation time

    Time frame: post op

  2. blood transfusion

    Time frame: post op

  3. length of stay in intensive-care unit

    Time frame: post op

Sponsors and collaborators

Lead sponsor

German Off Pump Coronary Artery Bypass in Elderly Study Group

Network

Collaborators

  • Deutsche Gesellschaft für Herz-, Thorax- und Gefäßchirurgie
  • Institut für Klinisch-Kardiovaskuläre Forschung GmbH

Registry information

Acronym: GOPCABE

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 22, 2008
Registry last updated
Oct 18, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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