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

This study has been completed.
Sponsor:
Collaborator:
International Anesthesia Research Society (IARS)
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00189215
First received: September 13, 2005
Last updated: December 3, 2007
Last verified: March 2005
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: September 13, 2005
Last Updated: December 3, 2007
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

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

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cognition Disorders
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 30, 2014