Half of DM patients had EEG changes and therefore were excluded.
Effect of Augmentation of Cerebral Blood Flow on Neuropsychometric Performance After Carotid Endarterectomy in Type II Diabetic Patients
Sponsor study identifier
interventional
10
1 country
1
Study Start
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 2014
Actual (reported)Click on a node to explore related trials.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
January 9, 2008
Actual (reported)January 18, 2008
Actual (reported)June 2014
Actual (reported)June 2014
Actual (reported)July 13, 2015
Actual (reported)Number of Participants With Improved Neuropsychometric Changes
Battery of neuropsychometric tests to evaluate a variety of cognitive functions.
Post-operatively at 1 day
Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by "conventional" management.
Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt even when by standard criteria they would not need to receive one.
When a shunt is inserted to increase blood flow to the brain
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.
Columbia University, Department of Anesthesiology
New York, New York, 10032, United States
Heyer EJ, Mergeche JL, Bruce SS, Connolly ES. Inflammation and cognitive dysfunction in type 2 diabetic carotid endarterectomy patients. Diabetes Care. 2013 Oct;36(10):3283-6. doi: 10.2337/dc12-2507. Epub 2013 Jun 4.
Eric J Heyer, M.D., Ph.D.
Columbia University
10 participants (actual enrollment reported by the registry).
First Submitted
January 9, 2008
First Posted
January 18, 2008
Study Start
March 2007
Date type not reportedThis date has not been verified as actual or estimated.
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Primary Completion
June 2014
Actual (reported)Study Completion
June 2014
Actual (reported)Last Updated
July 13, 2015
Results First Posted
July 13, 2015
Record last verified: 2015-06
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Source: ClinicalTrials.gov.
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