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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00189215
• Other study ID #: WOM protocol 98/009-O
• Status: Completed
• Phase: Phase 4
• First received: September 13, 2005
• Last updated: December 3, 2007
• Start date: March 1998
• Est. completion date: December 2005

Study information

• Verified date: March 2005
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 280
• Est. completion date: December 2005
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Cognition Disorders
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Device:
• cardiac stabilizer instead of cardiopulmonary bypass

Locations

Country	Name	City	State
Netherlands	University Medical Center, Department of Anesthesiology	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
UMC Utrecht	International Anesthesia Research Society (IARS)

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

Nathoe HM, van Dijk D, Jansen EW, Suyker WJ, Diephuis JC, van Boven WJ, de la Rivière AB, Borst C, Kalkman CJ, Grobbee DE, Buskens E, de Jaegere PP; Octopus Study Group. A comparison of on-pump and off-pump coronary bypass surgery in low-risk patients. N — View Citation

Van Dijk D, Jansen EW, Hijman R, Nierich AP, Diephuis JC, Moons KG, Lahpor JR, Borst C, Keizer AM, Nathoe HM, Grobbee DE, De Jaegere PP, Kalkman CJ; Octopus Study Group. Cognitive outcome after off-pump and on-pump coronary artery bypass graft surgery: a — View Citation

van Dijk D, Nierich AP, Eefting FD, Buskens E, Nathoe HM, Jansen EW, Borst C, Knape JT, Bredée JJ, Robles de Medina EO, Grobbee DE, Diephuis JC, de Jaegere PP. The Octopus Study: rationale and design of two randomized trials on medical effectiveness, safety, and cost-effectiveness of bypass surgery on the beating heart. Control Clin Trials. 2000 Dec;21(6):595-609. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	cognitive decline 5 year after the index treatment
Secondary	-freedom from cardiovascular events (i.e. mortality, stroke, myocardial infarction, re-CABG, or PTCA
Secondary	-recurrence of angina
Secondary	-use of anti-anginal drugs
Secondary	-quality of life (SF-36 and EuroQuol