Study of Carotid Occlusion and Neurocognition | NCT00390481

Studies
Study of Carotid Occlusion and Neurocognition

NCT00390481

Sponsor

Columbia University

Status

Completed

Last Update Posted

Jul 30, 2013Estimated

Enrollment

294Estimated

Phase

Not Applicable

Conditions

Carotid Artery Diseases

Interventions

EC-IC Bypass in the COSS study

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
5R01NS048212	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2004

Primary Completion Date

Jun 2012Actual

Completion Date

Jun 2012Actual

First Submitted Date

Oct 17, 2006

First Submission Date that Met QC Criteria

Oct 17, 2006

First Posted Date

Oct 19, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2013

Last Update Posted Date

Jul 30, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

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

Lead Sponsor

Columbia UniversityOTHER

Collaborators

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

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

294Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Other	EC-IC Bypass	Procedure: EC-IC Bypass in the COSS study
Control	No Intervention	Best Medical Therapy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EC-IC Bypass in the COSS study	Procedure	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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cognitive Functioning on Neuropsychological assessment measures		2 years

Secondary Outcomes

Measure	Description	Time Frame
Quality of Life and Disability		2 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Enrollment into Carotid Occlusion Surgery Study

Exclusion Criteria:

Prior diagnosis of dementia

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Randolph S Marshall, MD	Columbia University	Principal Investigator
Joanne R Festa, PhD	Columbia University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Columbia University Medical Center		New York	New York	10032	United States

Label	URL
Click here for more information about this study	View source

Condition Browse Module

MeSH Terms

ID	Term
D002340	Carotid Artery Diseases

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

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Browse Branches

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