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:
Information provided by (Responsible Party):
Eric J. Heyer, MD, PhD, Columbia University
ClinicalTrials.gov Identifier:
NCT00597545
First received: January 9, 2008
Last updated: June 19, 2015
Last verified: June 2015
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
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:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Number of Participants With Improved Neuropsychometric Changes [ Time Frame: Post-operatively at 1 day ] [ Designated as safety issue: No ]
    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

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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 9, 2008
Results First Received: June 2, 2015
Last Updated: June 19, 2015
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:
Carotid Artery Diseases
Carotid Stenosis
Cognition Disorders
Arterial Occlusive Diseases
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 29, 2015