Long-term cognitive decline after coronary artery bypass grafting: is off-pump surgery beneficial?
| ISRCTN | ISRCTN69438133 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN69438133 |
| Secondary identifying numbers | N/A |
- Submission date
- 24/04/2005
- Registration date
- 19/09/2005
- Last edited
- 27/09/2017
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Cor J Kalkman
Scientific
Scientific
University Medical Centre Utrecht
Dept of Anesthesiology
Heidelbergln 100
Utrecht
3584 CX
Netherlands
| c.j.kalkman@azu.nl |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | Long-term cognitive decline after coronary artery bypass grafting: is off-pump surgery beneficial? |
| Study acronym | Octopus Study |
| Study objectives | The aim of the present study is to compare the effect of coronary bypass surgery with and without cardiopulmonary bypass on cognitive outcome, five years after surgery. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Coronary artery disease |
| Intervention | Random allocation to on-pump or off-pump coronary artery bypass grafting |
| Intervention type | Other |
| Primary outcome measure | The primary endpoint of the present study is cognitive outcome at five years after surgery. Patients will undergo a battery of ten neuropsychologic tests five years after operation. The tests will be administered by a trained psychologist blinded for treatment allocation. Each individuals performance on the neuropsychologic tests will be compared to his or her performance on the same tests five years earlier, on the day before operation. In accordance to the Statement of Consensus on Assessment of Neurobehavioral Outcomes after Cardiac Surgery the test battery includes tests for motor skills, verbal memory capacity and attention. The principal outcome measure is cognitive decline, defined as a decrease in an individuals performance of at least 20 percent from baseline, in at least 20 percent of the tests. |
| Secondary outcome measures | 1. Quality of life at five years, assessed with the EuroQol10 and ShortForm-3611 questionnaires 2. The occurence of cardiovascular events i.e. mortality, stroke, myocardial infarction and coronary reintervention. Stroke is defined as focal brain injury, detected by standard neurologic examination, persisting for more than 24 hours, combined with an increase in handicap of at least one grade on the Rankin Scale; Myocardial infarction is considered present when two of the following criteria are met: chest discomfort lasting at least 30 minutes, CK-MB/CK ratio >0.1, and the development of abnormal new Q-waves in the electrocardiogram. 3. Anginal status at five years, defined according to the Canadian Cardiovascular Society and Braunwald classification 4. Use of antianginal medication at five years (Beta-blockers, nitrates or calcium entry-blockers) |
| Overall study start date | 01/01/1998 |
| Completion date | 31/12/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 281 |
| Key inclusion criteria | 281 candidates for coronary artery bypass surgery. Patients were eligible if referred for first-time isolated coronary bypass surgery and an off-pump procedure was deemed technically feasible. |
| Key exclusion criteria | 1. Patients were excluded in case of emergency or concomitant major surgery, Q-wave myocardial infarction in the last 6 weeks, or poor left ventricular function. 2. Patients who were unlikely to complete 1-year follow-up, unable to give informed consent, or undergo neuropsychologic testing were excluded. 3. There were no restrictions to age. |
| Date of first enrolment | 01/01/1998 |
| Date of final enrolment | 31/12/2000 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
University Medical Centre Utrecht
Utrecht
3584 CX
Netherlands
3584 CX
Netherlands
Sponsor information
International Anesthesia Research Society (USA)
Research organisation
Research organisation
2 Summit Park Drive, Suite 140
Cleveland
Ohio 44131
United States of America
| iarshq@iars.org | |
"ROR" |
https://ror.org/0252rqe04 |
Funders
Funder type
Research organisation
International Anesthesia Research Society
No information available
Clinical scholar research award 2004
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Other publications | rationale and design of the trial: | 01/12/2000 | Yes | No | |
| Results article | results: | 09/10/2001 | Yes | No | |
| Results article | results: | 20/03/2002 | Yes | No | |
| Results article | results: | 30/01/2003 | Yes | No | |
| Results article | results: | 01/04/2004 | Yes | No | |
| Results article | results: | 21/02/2007 | Yes | No |
Editorial Notes
27/09/2017: internal review.
