Study of Carotid Occlusion and Neurocognition

Not Applicable

Completed

• Conditions: Carotid Artery Diseases
• Interventions: Procedure: EC-IC Bypass in the COSS study

• Registration Number: NCT00390481
• Lead Sponsor: Columbia University

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.

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2006-10-17
• Study First Submitted QC: 2006-10-17
• Study First Posted: 2006-10-19
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-29
• Last Update Posted: 2013-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 294

Inclusion Criteria

• Enrollment into Carotid Occlusion Surgery Study

Exclusion Criteria

• Prior diagnosis of dementia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	EC-IC Bypass in the COSS study	EC-IC Bypass

Primary Outcome Measures

Name	Time	Method
Cognitive Functioning on Neuropsychological assessment measures	2 years

Secondary Outcome Measures

Name	Time	Method
Quality of Life and Disability	2 years

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States