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Effect of Raised CBF During CEA on Cognition in DM Patients

NCT00597545 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2015-07-13

Study results available
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Summary

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.

Conditions

  • Carotid Artery Disease
  • Carotid Artery Stenosis
  • Diabetes
  • Cognitive Dysfunction

Interventions

PROCEDURE

Carotid endarterectomy

When a shunt is inserted to increase blood flow to the brain

DEVICE

Shunt

A tube inserted below and above the surgical area at the time when the carotid artery is clamped to allow the surgeon to work in a bloodless field and to supplement blood flow to the brain.

Sponsors & Collaborators

Principal Investigators

  • Eric J Heyer, M.D., Ph.D. · Columbia University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2014-06-30
Completion
2014-06-30

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00597545 on ClinicalTrials.gov