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Completed

NCT Number: NCT00189215

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Medical Center, Department of Anesthesiology

Utrecht, 3584 CX, Netherlands

About this study

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.

Who can participate

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

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

Treatment and study plan

cardiac stabilizer instead of cardiopulmonary bypass

Device

Primary outcomes

  1. cognitive decline 5 year after the index treatment

Secondary outcomes

  1. -freedom from cardiovascular events (i.e. mortality, stroke, myocardial infarction, re-CABG, or PTCA

  2. -recurrence of angina

  3. -use of anti-anginal drugs

  4. -quality of life (SF-36 and EuroQuol

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • International Anesthesia Research Society (IARS)

Registry information

Important dates

Study start
1998
Study completion
2005
First posted
Sep 16, 2005
Registry last updated
Dec 4, 2007

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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