Effect of Raised CBF During CEA on Cognition in DM Patients
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Status:
This study is currently recruiting participants.
Purpose:
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".
Interventions:
Shunt
The use of a silicon tube, or shunt, as a temporary bypass can reduce the length of time that blood flow to the brain is interrupted during the operation
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Year Started:
2007
Design:
Interventional, Prevention, Randomized, Double Blind (Subject, Investigator), Uncontrolled, Single Group Assignment, Efficacy Study.
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.
Patient Involvement:
First, all patients will be evaluated using a battery of neuropsychometric tests before and after surgery. 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. They will be evaluated on the day of surgery. They will be evaluated 1 day, and 1 and 6 months after surgery.
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.
Primary Outcome:
Increase or decrease in cognitive function.
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Source of Information:
ClinicalTrials.gov
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Web Links and Publications:
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This information last updated on: 10/16/2009
Reviewed on: 09/14/2009.
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