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

NCT00189215 | Completed Phase 4

• 1 other identifier: WOM protocol 98/009-O
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease; Cardiopulmonary Bypass; Cognition Disorders

Keywords

coronary artery disease; cardiopulmonary bypass; cognition disorders

Outcome Measures

Primary Outcomes (1)

• cognitive decline 5 year after the index treatment

Secondary Outcomes (4)

• -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

Interventions

cardiac stabilizer instead of cardiopulmonary bypass DEVICE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• indication for (first-time) coronary artery bypass surgery
• off-pump CABG considered technically possible

You may not qualify if:

• concomitant valve surgery
• unable to complete neuropsychological testing
• life expectancy less than 1 year

Sponsors & Collaborators

• UMC Utrecht: lead
• International Anesthesia Research Society (IARS): collaborator

Study Sites (1)

University Medical Center, Department of Anesthesiology

Utrecht, Utrecht, 3584 CX, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 11146152 BACKGROUND

• 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.

  PMID: 11903027 RESULT

• 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.

  PMID: 12556542 RESULT

MeSH Terms

Conditions

Coronary Artery Disease; Cognition Disorders

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Cor J Kalkman, MD, PhD

  UMC Utrecht, The Netherlands

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 16, 2005
• Study Start: March 1, 1998
• Study Completion: December 1, 2005
• Last Updated: December 4, 2007

Record last verified: 2005-03

Locations

NL (1)