search
Back to results

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

Primary Purpose

Coronary Artery Disease, Cardiopulmonary Bypass, Cognition Disorders

Status
Completed
Phase
Phase 4
Locations
Netherlands
Study Type
Interventional
Intervention
cardiac stabilizer instead of cardiopulmonary bypass
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Artery Disease focused on measuring coronary artery disease, cardiopulmonary bypass, cognition disorders

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All Sexes

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

Sites / Locations

  • University Medical Center, Department of Anesthesiology

Outcomes

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

Full Information

First Posted
September 13, 2005
Last Updated
December 3, 2007
Sponsor
UMC Utrecht
Collaborators
International Anesthesia Research Society (IARS)
search

1. Study Identification

Unique Protocol Identification Number
NCT00189215
Brief Title
Long-Term Cognitive Decline After Coronary Artery Bypass Grafting: is Off-Pump Surgery Beneficial?
Official Title
Long-Term Cognitive Decline After Coronary Artery Bypass Grafting: is Off-Pump Surgery Beneficial?
Study Type
Interventional

2. Study Status

Record Verification Date
March 2005
Overall Recruitment Status
Completed
Study Start Date
March 1998 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
UMC Utrecht
Collaborators
International Anesthesia Research Society (IARS)

4. Oversight

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Cardiopulmonary Bypass, Cognition Disorders
Keywords
coronary artery disease, cardiopulmonary bypass, cognition disorders

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
280 (false)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
cardiac stabilizer instead of cardiopulmonary bypass
Primary Outcome Measure Information:
Title
cognitive decline 5 year after the index treatment
Secondary Outcome Measure Information:
Title
-freedom from cardiovascular events (i.e. mortality, stroke, myocardial infarction, re-CABG, or PTCA
Title
-recurrence of angina
Title
-use of anti-anginal drugs
Title
-quality of life (SF-36 and EuroQuol

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cor J Kalkman, MD, PhD
Organizational Affiliation
UMC Utrecht, The Netherlands
Official's Role
Study Director
Facility Information:
Facility Name
University Medical Center, Department of Anesthesiology
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
11146152
Citation
van Dijk D, Nierich AP, Eefting FD, Buskens E, Nathoe HM, Jansen EW, Borst C, Knape JT, Bredee 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. doi: 10.1016/s0197-2456(00)00103-3.
Results Reference
background
PubMed Identifier
11903027
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 randomized trial. JAMA. 2002 Mar 20;287(11):1405-12. doi: 10.1001/jama.287.11.1405.
Results Reference
result
PubMed Identifier
12556542
Citation
Nathoe HM, van Dijk D, Jansen EW, Suyker WJ, Diephuis JC, van Boven WJ, de la Riviere 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 Engl J Med. 2003 Jan 30;348(5):394-402. doi: 10.1056/NEJMoa021775.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs