Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON)
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.
Investigators
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)