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| Sponsors and Collaborators: |
Columbia University National Institute of Neurological Disorders and Stroke (NINDS) |
|---|---|
| Information provided by: | Columbia University |
| ClinicalTrials.gov Identifier: | NCT00390481 |
Purpose
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).
| Condition | Intervention |
|---|---|
|
Carotid Artery Diseases |
Procedure: EC-IC Bypass in the COSS study |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON) |
| Estimated Enrollment: | 294 |
| Study Start Date: | March 2005 |
| Estimated Study Completion Date: | December 2009 |
| Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Intervention
EC-IC Bypass
|
Procedure: EC-IC Bypass in the COSS study
EC-IC Bypass surgery involves taking an artery from the scalp outside the skull, making a small hole in the skull, and then connecting the scalp artery to a brain artery inside the skull. In this way, the blockage of the carotid artery in the neck is bypassed and more blood can flow to the brain.
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Control: No Intervention
Best Medical Therapy
|
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, we hope to determine whether the EC-IC bypass operation also helps improve or maintain mental functioning.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Kevin Slane, BA | 212 342 1152 | kslane@neuro.columbia.edu |
| Contact: Randolph S Marshall, MD | 212 305 8389 | rsm2@columbia.edu |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York, New York, United States, 10032 | |
| Contact: Randolph S Marshall, MD 212-305-8389 rsm2@columbia.edu | |
| Contact: Joanne R Festa, PhD 212 305 5860 jf2128@columbia.edu | |
| Principal Investigator: | Randolph S Marshall, MD | Columbia University |
| Principal Investigator: | Joanne R Festa, PhD | Columbia University |
More Information
| Responsible Party: | Columbia University ( Randolph S Marshall, MD ) |
| Study ID Numbers: | 5R01NS048212-02, AAAA8456 |
| Study First Received: | October 17, 2006 |
| Last Updated: | July 9, 2008 |
| ClinicalTrials.gov Identifier: | NCT00390481 |
| Health Authority: | United States: Institutional Review Board |
|
Carotid Occlusion Cognition |
|
Vascular Diseases Central Nervous System Diseases Brain Diseases Carotid Artery Diseases Cerebrovascular Disorders |
|
Nervous System Diseases Cardiovascular Diseases |
