Effect of Raised CBF During CEA on Cognition in DM Patients

June 19, 2015 updated by: Eric J. Heyer, MD, PhD, Columbia University

Effect of Augmentation of Cerebral Blood Flow on Neuropsychometric Performance After Carotid Endarterectomy in Type II Diabetic Patients

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Based on previous clinical studies, we have found that patients with diabetes mellitus (DM) who are having carotid endarterectomy (CEA) have a four-fold higher incidence of cognitive dysfunction, 1 day and 1 month after surgery, than a control group of elderly diabetic patients having spine surgery.

We hypothesize that this increased incidence is due to sub-cortical ischemia associated with the clamping of the ipsilateral carotid artery, because intra-operatively we rarely see EEG changes, or a significant number of emboli upon clamping or unclamping the carotid artery, or new cortical lesions of ischemia by MRI after surgery. In order to decrease cognitive dysfunction in patients with DM, we propose to randomize them to either i) have a shunt placed across the surgical site assuming it is surgically feasible or ii) be treated by "conventional" management during which time a shunt is placed only in the unlikely event of significant cortical ischemia determined by EEG, which occurs in about 5% of all cases.

The purpose of this study is to determine if patients with adult-onset diabetes mellitus having the surgical procedure called carotid endarterectomy benefit from increasing blood flow to the brain with a "shunt". A "shunt" is 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. Benefit is measured after surgery by comparing performance on a battery of cognitive tests, which test your ability to perform pencil-paper, memory and finger dexterity tests, to performance before surgery.

Patients in the shunt group whom the surgeon at the time of surgical exposure considers too technically difficult to shunt, will not have a shunt inserted but will be treated statistically as if they were shunted (intention to treat). Follow-up evaluations will be performed 1 day, and 1 and 6 months after surgery so that the long-term effect of shunting can be evaluated.

Cerebral injury will be determined in two ways.

First, all patients will be evaluated using a battery of neuropsychometric tests before and after surgery. Patients admitted to the Irving Clinical Research Center (CRC) will have their tests 1 day before, and 1 day, and 1 and 6 months after surgery. Those coming into the hospital on the day of surgery, "Same Day", will be evaluated on the day of surgery. They will be evaluated 1 day, and 1 and 6 months after surgery.

Preoperative neurological and neuropsychological evaluation will be performed. The neuropsychometric tests are not intended to be diagnostic of specific neuropsychiatric disorders, but rather are designed to demonstrate general neuropsychological pathology. These tests can be divided into four types: (1) an evaluation of language, (2) an evaluation of speed of mental processing, (3) an evaluation of ability to learn using a list of words, and (4) an evaluation of visual perception requiring a patient to copy a complex figure. Before the battery is administered we will assess each patient's level of pain while sitting and standing using a 10 point Visual Analog Scale and gauge their mood with a series called the Wong/Baker Faces Rating scale. Patients having spine surgery may have significant pain before surgery which might impair their performance.

We will also be measuring Quality of Life (QOL) in all enrolled patients.

This will be done using two well-known examinations (Telephone Interview for Cognitive Status (TICS) and Centers for Disease Control and Prevention Health-Related Quality-of-Life 14Item Measure (CDC HRQOL14)) and a series of questions investigating how well patients are able to perform activities of daily living (ADLs) and instrumental activities of daily living (IADLs). These tests will be given at two time points, once before the surgery and then one month after surgery. We will look for changes in quality of life that may correlate with neuropsychometric test performance.

Second, peripheral serum samples will be drawn before induction, before crossclamping the carotid artery, 15 minutes after crossclamping the carotid artery and 24 hours after surgery.

Since the purpose of this study is to determine if a change in "conventional" management will improve patient's ability to perform our battery of neuropsychometric tests, 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 its 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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Post-operatively at 1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Columbia University

Investigators

  • Principal Investigator: Eric J Heyer, M.D., Ph.D., Columbia University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

June 1, 2014

Study Completion (Actual)

June 1, 2014

Study Registration Dates

First Submitted

January 9, 2008

First Submitted That Met QC Criteria

January 9, 2008

First Posted (Estimate)

January 18, 2008

Study Record Updates

Last Update Posted (Estimate)

July 13, 2015

Last Update Submitted That Met QC Criteria

June 19, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAAC3837

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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