Does APOE-e4 Predict Delirium and Cognitive Dysfunction After Surgery?

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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

Secondary Measures

  • POCD as assessed by a battery of 9 neuropsychometric tests
    • Time Frame: 7 days postoperatively
      Safety Issue?: Yes
  • POCD as assessed by a battery of 9 neuropsychometric tests
    • Time Frame: 3 months postoperatively
      Safety Issue?: Yes

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