Study of Carotid Occlusion and Neurocognition

Sponsor

Columbia University (Other)

Overall Status

Completed

CT.gov ID

NCT00390481

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

294

Enrollment

Location

Arms

Duration (Months)

3.2

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Carotid Artery Diseases	Procedure: EC-IC Bypass in the COSS study	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

294 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON)

Study Start Date :

Nov 1, 2004

Actual Primary Completion Date :

Jun 1, 2012

Actual Study Completion Date :

Jun 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Other: 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.
No Intervention: Control Best Medical Therapy

Arm

Intervention/Treatment

Other: 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.

No Intervention: Control

Best Medical Therapy

Outcome Measures

Primary Outcome Measures

Cognitive Functioning on Neuropsychological assessment measures [2 years]

Secondary Outcome Measures

Quality of Life and Disability [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Enrollment into Carotid Occlusion Surgery Study

Exclusion Criteria:

Prior diagnosis of dementia

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Columbia University Medical Center	New York	New York	United States	10032

Sponsors and Collaborators

Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator: Randolph S Marshall, MD, Columbia University
Principal Investigator: Joanne R Festa, PhD, Columbia University

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Click here for more information about this study

Publications

None provided.

Responsible Party:

Randolph S. Marshall, Professor at Affil Hosp/Inst, Columbia University

ClinicalTrials.gov Identifier:

NCT00390481

Other Study ID Numbers:

AAAA8456
5R01NS048212

First Posted:

Oct 19, 2006

Last Update Posted:

Jul 30, 2013

Last Verified:

Jul 1, 2013

Keywords provided by Randolph S. Marshall, Professor at Affil Hosp/Inst, Columbia University

Carotid Occlusion

Cognition

Additional relevant MeSH terms:

Carotid Artery Diseases

Study Results

No Results Posted as of Jul 30, 2013