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

September 13, 2005
December 3, 2007
March 1998
Not Provided
cognitive decline 5 year after the index treatment
Same as current
Complete list of historical versions of study NCT00189215 on ClinicalTrials.gov Archive Site
  • -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
Same as current
Not Provided
Not Provided
 
Long-Term Cognitive Decline After Coronary Artery Bypass Grafting: is Off-Pump Surgery Beneficial?
Long-Term Cognitive Decline After Coronary Artery Bypass Grafting: is Off-Pump Surgery Beneficial?

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.

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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Prevention
  • Coronary Artery Disease
  • Cardiopulmonary Bypass
  • Cognition Disorders
Device: cardiac stabilizer instead of cardiopulmonary bypass
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
280
December 2005
Not Provided

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
Both
18 Years and older
Not Provided
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
NCT00189215
WOM protocol 98/009-O
Not Provided
Not Provided
UMC Utrecht
International Anesthesia Research Society (IARS)
Study Director: Cor J Kalkman, MD, PhD UMC Utrecht, The Netherlands
UMC Utrecht
March 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP