Study of Carotid Occlusion and Neurocognition
Primary Purpose
Carotid Artery Diseases
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
EC-IC Bypass in the COSS study
Sponsored by
About this trial
This is an interventional treatment trial for Carotid Artery Diseases focused on measuring Carotid Occlusion, Cognition
Eligibility Criteria
Inclusion Criteria:
- Enrollment into Carotid Occlusion Surgery Study
Exclusion Criteria:
- Prior diagnosis of dementia
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
Intervention
Control
Arm Description
EC-IC Bypass
Best Medical Therapy
Outcomes
Primary Outcome Measures
Cognitive Functioning on Neuropsychological assessment measures
Secondary Outcome Measures
Quality of Life and Disability
Full Information
NCT ID
NCT00390481
First Posted
October 17, 2006
Last Updated
July 29, 2013
Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT00390481
Brief Title
Study of Carotid Occlusion and Neurocognition
Official Title
Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
November 2004 (undefined)
Primary Completion Date
June 2012 (Actual)
Study Completion Date
June 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Diseases
Keywords
Carotid Occlusion, Cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
294 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Other
Arm Description
EC-IC Bypass
Arm Title
Control
Arm Type
No Intervention
Arm Description
Best Medical Therapy
Intervention Type
Procedure
Intervention Name(s)
EC-IC Bypass in the COSS study
Intervention Description
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.
Primary Outcome Measure Information:
Title
Cognitive Functioning on Neuropsychological assessment measures
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Quality of Life and Disability
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Enrollment into Carotid Occlusion Surgery Study
Exclusion Criteria:
Prior diagnosis of dementia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randolph S Marshall, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Joanne R Festa, PhD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
12. IPD Sharing Statement
Links:
URL
http://cosstrial.org/coss/homerecon.asp
Description
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Study of Carotid Occlusion and Neurocognition
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