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Reduced Manipulation of the Aorta and Neurobehavioral Outcome Trial

Sponsor
National Institute of Neurological Disorders and Stroke (NINDS) (NIH)
Overall Status
Completed
CT.gov ID
NCT00059319
Collaborator
(none)
300
Enrollment
1
Location

Study Details

Study Description

Brief Summary

The purpose of this trial is to determine whether aortic manipulation in patients undergoing coronary bypass graft surgery leads to increased incidence of microemboli and subsequent impairment of neurobehavioral function.

Condition or Disease Intervention/Treatment Phase
  • Procedure: single aorta clamp with retrograde cardioplegia
  • Procedure: multiple aorta clamps with antegrade cardioplegia
 Phase 3

Detailed Description

Patients who have coronary artery bypass graft (CABG) surgery must have their aorta (the large blood vessel that is attached to the heart) clamped with an instrument. There are two basic ways of manipulating the aorta during surgery. One way is to place a single clamp across the aorta. The other way is to place more than one clamp on the aorta in several places. Both methods are used, but it is not known if one way is better than the other.

The purpose of this study is to compare the two methods of clamping to see if one way is better than the other, and to determine whether patients who undergo reduced manipulation of the aorta have fewer microemboli delivered to the brain during CABG surgery and have a lower incidence of neurobehavioral problems following surgery. Microemboli are tiny fat particles that enter the bloodstream during surgery, circulate to the brain, and block tiny blood vessels, causing brain deficits.

Participants in this trial will be randomly classified into one of two groups: the experimental group will undergo cross clamping of the aorta with a single clamp and be given retrograde cardioplegia for heart protection, and the control group will undergo cross clamping of the aorta with multiple clamps and be given antegrade cardioplegia for heart protection. Neurobehavioral assessments will be accomplished with a comprehensive battery of neurological and neuropsychological tests.

Study Design

Study Type:
Interventional
Allocation:
Randomized
Primary Purpose:
Treatment
Study Start Date :
Jan 1, 1999

Outcome Measures

Primary Outcome Measures

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    • Participants must be English-speaking patients,

    • 50 years of age or older, and

    • undergoing elective CABG surgery.

    • Participants of both genders and all races are eligible.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Wake Forest University Baptist Medical Center Winston Salem North Carolina United States 27157

    Sponsors and Collaborators

    • National Institute of Neurological Disorders and Stroke (NINDS)

    Investigators

    • Principal Investigator: John W. Hammon, M.D., Wake Forest University Health Sciences

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00059319
    Other Study ID Numbers:
    • R01NS037242
    First Posted:
    Apr 24, 2003
    Last Update Posted:
    May 21, 2007
    Last Verified:
    May 1, 2007
    Keywords provided by , ,
    coronary artery bypass graft surgery
    CABG surgery
    neurobehavioral impairment
    aorta clamping
    aorta manipulation
    microemboli
    Additional relevant MeSH terms:
    Coronary Disease

    Study Results

    No Results Posted as of May 21, 2007