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Study of Carotid Occlusion and Neurocognition

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Columbia University

Status

Completed

Conditions

Carotid Artery Diseases

Treatments

Procedure: EC-IC Bypass in the COSS study

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT00390481
AAAA8456
5R01NS048212 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment

294 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Enrollment into Carotid Occlusion Surgery Study

Exclusion criteria

  • Prior diagnosis of dementia

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

294 participants in 2 patient groups

Intervention
Other group
Description:
EC-IC Bypass
Treatment:
Procedure: EC-IC Bypass in the COSS study
Control
No Intervention group
Description:
Best Medical Therapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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