Effect of Raised CBF During CEA on Cognition in DM Patients
This study is currently recruiting participants.
Verified November 2012 by Columbia University
Sponsor:
Columbia University
Information provided by (Responsible Party):
Eric J. Heyer, MD, PhD, Columbia University
ClinicalTrials.gov Identifier:
NCT00597545
First received: January 9, 2008
Last updated: November 21, 2012
Last verified: November 2012
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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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group 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:
- Neuropsychometric Changes [ Time Frame: Morning of surgery and post-operatively at 1 day, 1 month, and 6 months ] [ Designated as safety issue: No ]Battery of neuropsychometric tests to evaluate a variety of cognitive functions.
| Estimated Enrollment: | 400 |
| Study Start Date: | March 2007 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Conventional Shunt
Subjects will receive a shunt only if it is indicated by EEG, "conventional" management.
|
Procedure: Shunt
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.
|
|
Experimental: Prophylactic Shunt
Subjects in the prophylactic group will receive a shunt even when by standard criteria they would not need to receive one.
|
Procedure: Shunt
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.
|
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00597545
Contacts
| Contact: Joanna L Mergeche, BA | 212-305-8949 | jm3596@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: | 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 |
| Last Updated: | November 21, 2012 |
| 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 Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Vascular Diseases Cardiovascular Diseases Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on May 23, 2013