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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

October 17, 2006
July 29, 2013
November 2004
June 2012   (final data collection date for primary outcome measure)
Cognitive Functioning on Neuropsychological assessment measures [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Cognitive Functioning at two years
Complete list of historical versions of study NCT00390481 on ClinicalTrials.gov Archive Site
Quality of Life and Disability [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • PET OEF at 3 months
  • Cognitive Functioning at 3 months
  • Quality of Life and Disability at 2 years
Not Provided
Not Provided
 
Study of Carotid Occlusion and Neurocognition
Randomized Evaluation of Carotid Occlusion and Neurocognition (RECON)

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Carotid Artery Diseases
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.
  • Intervention
    EC-IC Bypass
    Intervention: Procedure: EC-IC Bypass in the COSS study
  • No Intervention: Control
    Best Medical Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
294
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Enrollment into Carotid Occlusion Surgery Study

Exclusion Criteria:

  • Prior diagnosis of dementia
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00390481
AAAA8456, 5R01NS048212
Yes
Randolph S. Marshall, Columbia University
Columbia University
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Randolph S Marshall, MD Columbia University
Principal Investigator: Joanne R Festa, PhD Columbia University
Columbia University
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP