Study of Carotid Occlusion and Neurocognition

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Randolph S. Marshall, Columbia University
ClinicalTrials.gov Identifier:
NCT00390481
First received: October 17, 2006
Last updated: July 29, 2013
Last verified: July 2013
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON)

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Cognitive Functioning on Neuropsychological assessment measures [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of Life and Disability [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 294
Study Start Date: November 2004
Study Completion Date: June 2012
Primary Completion Date: June 2012 (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.
No Intervention: Control
Best Medical Therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Enrollment into Carotid Occlusion Surgery Study

Exclusion Criteria:

  • Prior diagnosis of dementia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00390481

Locations
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: Randolph S Marshall, MD Columbia University
Principal Investigator: Joanne R Festa, PhD Columbia University
  More Information

No publications provided

Responsible Party: Randolph S. Marshall, Professor at Affil Hosp/Inst, Columbia University
ClinicalTrials.gov Identifier: NCT00390481     History of Changes
Other Study ID Numbers: AAAA8456, 5R01NS048212
Study First Received: October 17, 2006
Last Updated: July 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Carotid Occlusion
Cognition

Additional relevant MeSH terms:
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014