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Study of Carotid Occlusion and Neurocognition

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00390481
Recruitment Status : Completed
First Posted : October 19, 2006
Last Update Posted : July 30, 2013
Information provided by (Responsible Party):

October 17, 2006
October 19, 2006
July 30, 2013
November 2004
June 2012   (Final data collection date for primary outcome measure)
Cognitive Functioning on Neuropsychological assessment measures [ Time Frame: 2 years ]
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 ]
  • 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.
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
5R01NS048212 ( U.S. NIH Grant/Contract )
Not Provided
Not Provided
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