Does APOE-e4 Predict Delirium and Cognitive Dysfunction After Surgery?
Patients with the APOE-ε4 genotype are at increased risk of both vascular dementia and peripheral vascular disease. Patients undergoing major vascular surgery are at particularly high risk of delirium and other, more subtle, changes in cognitive function following surgery. The hypothesis of this trial is that the APOE-ε4 genotype is associated with both delirium and postoperative cognitive...
Brief Summary
Official Title: “Does Apolipoprotein E Genotype Predict Delirium and Postoperative Cognitive Dysfunction?”
Patients with the APOE-ε4 genotype are at increased risk of both vascular dementia and peripheral vascular disease. Patients undergoing major vascular surgery are at particularly high risk of delirium and other, more subtle, changes in cognitive function following surgery. The hypothesis of this trial is that the APOE-ε4 genotype is associated with both delirium and postoperative cognitive dysfunction (POCD).
- Study Type: Observational
- Study Design: Observational Model: Cohort, Time Perspective: Prospective
- Study Primary Completion Date: March 2008
Arms, Groups and Cohorts in this Clinical Trial
- : Open Aortic Repair
- Patients 60 years of age and older undergoing open repair of the abdominal aorta
Outcome Measures for this Clinical Trial
Primary Measures
- Delirium as assessed by the Confusion Assessment Method
- Time Frame: 7 days postoperatively
Safety Issue?: Yes
- Time Frame: 7 days postoperatively
Secondary Measures
- POCD as assessed by a battery of 9 neuropsychometric tests
- Time Frame: 7 days postoperatively
Safety Issue?: Yes
- Time Frame: 7 days postoperatively
- POCD as assessed by a battery of 9 neuropsychometric tests
- Time Frame: 3 months postoperatively
Safety Issue?: Yes
- Time Frame: 3 months postoperatively
Criteria for Participation in this Clinical Trial
Inclusion Criteria:
- Age 60 or greater
- Open repair of the abdominal aorta
Exclusion Criteria:
- refusal;
- planned endovascular repair;
- emergency surgery;
- previous diagnosis of dementia, Parkinson's disease, or psychiatric illness;
- active alcohol or substance abuse; and
- physical inability to complete neuropsychometric testing.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 60 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Investigator Information
Lead Investigator: Ottawa Hospital Research Institute Other
Overall Clinical Trial Officials and Contacts
Gregory L Bryson, MD, FRCPC Principal Investigator Department of Anesthesiology, The Ottawa Hospital
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00911677
Study ID Number: OHREB 2004800-01H
ClinicalTrials.gov Identifier: NCT00911677
Health Authority: Canada: Ethics Review Committee
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00911677
