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Long-Term Cognitive Decline After Coronary Artery Bypass Grafting: is Off-Pump Surgery Beneficial?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00189215
First Posted: September 16, 2005
Last Update Posted: December 4, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
International Anesthesia Research Society (IARS)
Information provided by:
UMC Utrecht
  Purpose
Coronary artery bypass surgery is associated with postoperative cognitive decline, which has largely been attributed to the use of the heart lung machine. We hypothesized that long-term cognitive outcome may improve by avoiding the heart lung machine. The objective of the present study is to compare the effect of coronary bypass surgery with and without heart lung machine on cognitive and clinical outcome, five years after surgery.

Condition Intervention Phase
Coronary Artery Disease Cardiopulmonary Bypass Cognition Disorders Device: cardiac stabilizer instead of cardiopulmonary bypass Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Long-Term Cognitive Decline After Coronary Artery Bypass Grafting: is Off-Pump Surgery Beneficial?

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • cognitive decline 5 year after the index treatment

Secondary Outcome Measures:
  • -freedom from cardiovascular events (i.e. mortality, stroke, myocardial infarction, re-CABG, or PTCA
  • -recurrence of angina
  • -use of anti-anginal drugs
  • -quality of life (SF-36 and EuroQuol

Estimated Enrollment: 280
Study Start Date: March 1998
Estimated Study Completion Date: December 2005
Detailed Description:

Background:

Coronary artery bypass surgery is associated with postoperative cognitive decline, which has largely been attributed to the use of cardiopulmonary bypass (CPB). A large recent study by Newman et al demonstrated that the incidence of cognitive decline was 24% at six months after surgery, but it increased to 42% at five years. In the recently conducted Octopus Randomized Trial, cognitive decline at three months after surgery was present in 29% of the patients operated with CPB. In the patients operated without CPB, the incidence was 21%, i.e. only slightly better.

Hypothesis:

Improvement of cognitive outcome by avoiding cardiopulmonary bypass will become more apparent five years after surgery, compared to three months after surgery.

Study objectives:

The objective of the present study is to compare the effect of coronary bypass surgery with and without cardiopulmonary bypass on cognitive and clinical outcome, five years after surgery.

Methods:

The 281 participants of the Octopus Study, who were operated on between March 1998 and August 2000 and randomized to off-pump or on-pump coronary bypass surgery, will be invited for an additional assessment of their cognitive and clinical status and quality of life, five years after surgery. Patients will undergo a battery of ten neuropsychologic tests to determine their cognitive status. Clinical status will be assessed by an interview. Questionnaires will be used to measure quality of life.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Criteria

Inclusion Criteria:

  • indication for (first-time) coronary artery bypass surgery
  • off-pump CABG considered technically possible

Exclusion Criteria:

  • concomitant valve surgery
  • unable to complete neuropsychological testing
  • life expectancy less than 1 year
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189215


Locations
Netherlands
University Medical Center, Department of Anesthesiology
Utrecht, Netherlands, 3584 CX
Sponsors and Collaborators
UMC Utrecht
International Anesthesia Research Society (IARS)
Investigators
Study Director: Cor J Kalkman, MD, PhD UMC Utrecht, The Netherlands
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00189215     History of Changes
Other Study ID Numbers: WOM protocol 98/009-O
First Submitted: September 13, 2005
First Posted: September 16, 2005
Last Update Posted: December 4, 2007
Last Verified: March 2005

Keywords provided by UMC Utrecht:
coronary artery disease
cardiopulmonary bypass
cognition disorders

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cognitive Dysfunction
Cognition Disorders
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Neurocognitive Disorders
Mental Disorders