We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effect of Raised CBF During CEA on Cognition in DM Patients

This study has been terminated.
(Half of DM patients had EEG changes and therefore were excluded.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00597545
First Posted: January 18, 2008
Last Update Posted: July 13, 2015
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.
Information provided by (Responsible Party):
Eric J. Heyer, MD, PhD, Columbia University
  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 Cognitive Dysfunction Procedure: Carotid endarterectomy Device: Shunt

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Effect of Augmentation of Cerebral Blood Flow on Neuropsychometric Performance After Carotid Endarterectomy in Type II Diabetic Patients

Further study details as provided by Eric J. Heyer, MD, PhD, Columbia University:

Primary Outcome Measures:
  • Number of Participants With Improved Neuropsychometric Changes [ Time Frame: Post-operatively at 1 day ]
    Battery of neuropsychometric tests to evaluate a variety of cognitive functions.


Enrollment: 10
Study Start Date: March 2007
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Conventional Shunt
Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by "conventional" management.
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.
Experimental: Prophylactic Shunt
Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.
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.

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00597545


Locations
United States, New York
Columbia University, Department of Anesthesiology
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

Publications:
Responsible Party: Eric J. Heyer, MD, PhD, Professor of Clinical, Department of Anethesiology Clinical Operations, Columbia University
ClinicalTrials.gov Identifier: NCT00597545     History of Changes
Other Study ID Numbers: AAAC3837
First Submitted: January 9, 2008
First Posted: January 18, 2008
Results First Submitted: June 2, 2015
Results First Posted: July 13, 2015
Last Update Posted: July 13, 2015
Last Verified: June 2015

Keywords provided by Eric J. Heyer, MD, PhD, Columbia University:
Carotid Endarterectomy
Neuropsychological tests
Stroke
Transient ischemia
Hypoperfusion
Ischemia

Additional relevant MeSH terms:
Cognitive Dysfunction
Carotid Artery Diseases
Carotid Stenosis
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases