Effect of Raised CBF During CEA on Cognition in DM Patients - Full Text View

Sponsor:	Columbia University
Information provided by:	Columbia University
ClinicalTrials.gov Identifier:	NCT00597545

Purpose

The purpose of this study is to determine if we can reduce the incidence of cognitive dysfunction — difficulty in performing certain pencil-paper, memory, finger dexterity and thinking type of tasks called neuropsychometric tests — in patients with adult onset diabetes mellitus (DM) undergoing surgery on the carotid artery (CEA).

We hypothesize that cognitive dysfunction can be decreased in patients with type II DM by augmenting cerebral blood flow with a shunt during carotid endarterectomy compared to patients with Type II DM who are treated with "conventional" management in which a shunt is placed only if the electroencephalogram (EEG) indicates cerebral ischemia.

Condition	Intervention
Carotid Artery Disease Carotid Artery Stenosis Diabetes Cognition	Procedure: Shunt

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Effect of Augmentation of Cerebral Blood Flow on Neuropsychometric Performance After Carotid Endarterectomy in Type II Diabetic Patients

Resource links provided by NLM:

MedlinePlus related topics: Carotid Artery Disease Diabetes Surgery

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

Increase or decrease in cognitive function [ Time Frame: prior to surgery, 1 day post surgery, 1 month post surgery, 6 months post surgery ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	March 2007
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Intervention Details:

We will randomly assign patients to either receive a "shunt" prophylactically if the surgeon determines that it is technically safe, even if conventional management does not indicate it is necessary, or a "shunt" only if it is indicated by EEG, "conventional" management. Subjects in the prophylactic group will receive a shunt even when by standard criteria they would not need to receive one. Randomization will be performed in blocks of four patients each using a randomization table. Using "block" randomization we will increase the probability of an equal number of patients "shunted" or not shunted. The surgeon will be told which group the patient has been randomized into after induction and prior to clamping the carotid artery.

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Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

ability to speak English
no history of permanent neurological impairment, Axis I psychiatric diagnosis or drug abuse.
scheduled for elective carotid endarterectomy for treatment of carotid artery stenosis.
diagnosed with diabetes mellitus or HbA1c value greater than 10%

Exclusion Criteria:

younger than 18 yrs.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00597545

Contacts

Contact: Anna Granat, BA	212-305-8949	a.granat@columbia.edu
Contact: Eric Heyer, M.D., Ph.D.	212-305-9072	ejh3@columbia.edu

Locations

United States, New York
Columbia University, Department of Anesthesiology	Recruiting
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Investigators

Principal Investigator:

Eric J Heyer, M.D., Ph.D.

Columbia University

More Information

No publications provided

Responsible Party:	Columbia University, Department of Anesthesiology ( Eric Heyer, M.D., Ph.D. )
Study ID Numbers:	AAAC3837
Study First Received:	January 9, 2008
Last Updated:	October 10, 2008
ClinicalTrials.gov Identifier:	NCT00597545 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia University:

carotid endarterectomy
Neuropsychological tests
Stroke

Transient ischemia
Hypoperfusion
Ischemia

Additional relevant MeSH terms:

Arterial Occlusive Diseases
Carotid Stenosis
Nervous System Diseases
Vascular Diseases
Central Nervous System Diseases

Cardiovascular Diseases
Brain Diseases
Carotid Artery Diseases
Cerebrovascular Disorders

ClinicalTrials.gov processed this record on February 08, 2010