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Clinical Trials/NCT00390481
NCT00390481
Completed
Not Applicable

Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON)

Columbia University1 site in 1 country294 target enrollmentNovember 2004

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carotid Artery Diseases
Sponsor
Columbia University
Enrollment
294
Locations
1
Primary Endpoint
Cognitive Functioning on Neuropsychological assessment measures
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

To determine the relationship between cognitive functioning and blood flow in the brain among patients randomized to either extracranial-intracranial (EC-IC) bypass or medical therapy alone in the Carotid Occlusion Surgery Study (COSS).

Detailed Description

The Carotid Occlusion Surgery Study (COSS) evaluates whether a surgical operation, EC-IC bypass surgery, can reduce the chance of a stroke in someone who has complete blockage in one main artery in the neck that supplies blood to the brain (the carotid artery). The operation bypasses the blockage so more blood can flow to the brain. Only people with decreased blood flow to the brain, as demonstrated on a PET (positron emission tomographic) scan, are randomized into the COSS study. Among patients randomized into the COSS study, RECON will evaluate whether restoring the blood flow to the brain (with EC-IC bypass surgery) will also improve mental functioning. Participants in both the surgical and medical groups of the COSS study will participate in the RECON study. By comparing the mental functioning of the participants in both treatment groups over the course of 2 years, the investigators hope to determine whether the EC-IC bypass operation also helps improve or maintain mental functioning.

Registry
clinicaltrials.gov
Start Date
November 2004
End Date
June 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Randolph S. Marshall

Professor at Affil Hosp/Inst

Columbia University

Eligibility Criteria

Inclusion Criteria

  • Enrollment into Carotid Occlusion Surgery Study

Exclusion Criteria

  • Prior diagnosis of dementia

Outcomes

Primary Outcomes

Cognitive Functioning on Neuropsychological assessment measures

Time Frame: 2 years

Secondary Outcomes

  • Quality of Life and Disability(2 years)

Study Sites (1)

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