NCT00911677

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2005

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2005

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

May 29, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 2, 2009

Completed
Last Updated

June 2, 2009

Status Verified

May 1, 2009

Enrollment Period

2.6 years

First QC Date

May 29, 2009

Last Update Submit

May 29, 2009

Conditions

Keywords

Delirium (MeSH Unique ID D003693)Cognition Disorders (MeSH Unique ID D003072)Postoperative Complications (MeSH Unique ID D011183)Apolipoproteins E (MeSH Unique ID D001057)

Outcome Measures

Primary Outcomes (1)

  • Delirium as assessed by the Confusion Assessment Method

    7 days postoperatively

Secondary Outcomes (2)

  • POCD as assessed by a battery of 9 neuropsychometric tests

    7 days postoperatively

  • POCD as assessed by a battery of 9 neuropsychometric tests

    3 months postoperatively

Study Arms (1)

Open Aortic Repair

Patients 60 years of age and older undergoing open repair of the abdominal aorta

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients 60 years of age or greater undergoing open repair of the abdominal aorta at an academic tertiary care hospital.

You may qualify if:

  • Age 60 or greater
  • Open repair of the abdominal aorta

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital - Civic Campus

Ottawa, Ontario, K1Y 4E9, Canada

Location

Related Publications (2)

  • Bryson GL, Wyand A, Wozny D, Rees L, Taljaard M, Nathan H. A prospective cohort study evaluating associations among delirium, postoperative cognitive dysfunction, and apolipoprotein E genotype following open aortic repair. Can J Anaesth. 2011 Mar;58(3):246-55. doi: 10.1007/s12630-010-9446-6. Epub 2011 Jan 11.

  • Bryson GL, Wyand A, Wozny D, Rees L, Taljaard M, Nathan H. The clock drawing test is a poor screening tool for postoperative delirium and cognitive dysfunction after aortic repair. Can J Anaesth. 2011 Mar;58(3):267-74. doi: 10.1007/s12630-010-9448-4. Epub 2010 Dec 31.

MeSH Terms

Conditions

DeliriumPostoperative Cognitive ComplicationsCognition DisordersPostoperative Complications

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersPathologic ProcessesCognitive Dysfunction

Study Officials

  • Gregory L Bryson, MD, FRCPC

    Department of Anesthesiology, The Ottawa Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 29, 2009

First Posted

June 2, 2009

Study Start

August 1, 2005

Primary Completion

March 1, 2008

Study Completion

May 1, 2009

Last Updated

June 2, 2009

Record last verified: 2009-05

Locations