NCT00597545

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

January 9, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

January 18, 2008

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

July 13, 2015

Completed
Last Updated

July 13, 2015

Status Verified

June 1, 2015

Enrollment Period

7.3 years

First QC Date

January 9, 2008

Results QC Date

June 2, 2015

Last Update Submit

June 19, 2015

Conditions

Carotid Artery DiseaseCarotid Artery StenosisDiabetesCognitive Dysfunction

Keywords

Carotid EndarterectomyNeuropsychological testsStrokeTransient ischemiaHypoperfusionIschemia

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Improved Neuropsychometric Changes

    Battery of neuropsychometric tests to evaluate a variety of cognitive functions.

    Post-operatively at 1 day

Study Arms (2)

Conventional Shunt

ACTIVE COMPARATOR

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

Procedure: Carotid endarterectomyDevice: Shunt

Prophylactic Shunt

EXPERIMENTAL

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 endarterectomyDevice: Shunt

Interventions

Carotid endarterectomyPROCEDURE

When a shunt is inserted to increase blood flow to the brain

Conventional ShuntProphylactic Shunt
ShuntDEVICE

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.

Conventional ShuntProphylactic Shunt

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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%

You may not qualify if:

  • younger than 18 yrs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Columbia University, Department of Anesthesiology

New York, New York, 10032, United States

Location

Related Publications (1)

  • 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.

    PMID: 23735728RESULT

MeSH Terms

Conditions

Carotid Artery DiseasesCarotid StenosisDiabetes MellitusCognitive DysfunctionStrokeIschemia

Interventions

Endarterectomy, Carotid

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesArterial Occlusive DiseasesGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesCognition DisordersNeurocognitive DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

EndarterectomyVascular Surgical ProceduresCardiovascular Surgical ProceduresSurgical Procedures, Operative

Results Point of Contact

Title
Eric J Heyer
Organization
Columbia University
ejh3@cumc.columbia.edu
212-305-9072

Study Officials

  • Eric J Heyer, M.D., Ph.D.

    Columbia University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Clinical, Department of Anethesiology Clinical Operations

Study Record Dates

First Submitted

January 9, 2008

First Posted

January 18, 2008

Study Start

March 1, 2007

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

July 13, 2015

Results First Posted

July 13, 2015

Record last verified: 2015-06

Locations

US(1)