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
Results First Received: June 2, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Prevention
Conditions: Carotid Artery Disease
Carotid Artery Stenosis
Diabetes
Cognitive Dysfunction
Interventions: Procedure: Carotid endarterectomy
Device: Shunt

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Conventional Shunt

Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by "conventional" management.

Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain

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.

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.

Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain

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.


Participant Flow:   Overall Study
    Conventional Shunt     Prophylactic Shunt  
STARTED     4     6  
COMPLETED     4     6  
NOT COMPLETED     0     0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Conventional Shunt

Patients with diabetes mellitus (DM) undergoing carotid endarterectomy will receive a shunt only if it is indicated by EEG, by "conventional" management.

Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain

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.

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.

Carotid endarterectomy: When a shunt is inserted to increase blood flow to the brain

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.

Total Total of all reporting groups

Baseline Measures
    Conventional Shunt     Prophylactic Shunt     Total  
Number of Participants  
[units: participants]
  4     6     10  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     0     0     0  
>=65 years     4     6     10  
Age  
[units: years]
Mean (Full Range)
  68   (64 to 78)     69   (65 to 79)     68.7   (64 to 79)  
Gender  
[units: participants]
     
Female     2     4     6  
Male     2     2     4  
Region of Enrollment  
[units: participants]
     
United States     4     6     10  



  Outcome Measures

1.  Primary:   Number of Participants With Improved Neuropsychometric Changes   [ Time Frame: Post-operatively at 1 day ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Eric J Heyer
Organization: Columbia University
phone: 212-305-9072
e-mail: ejh3@cumc.columbia.edu


Publications of Results:

Responsible Party: Eric J. Heyer, MD, PhD, 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