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Reduced Manipulation of the Aorta and Neurobehavioral Outcome Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00059319
First Posted: April 24, 2003
Last Update Posted: May 21, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)
  Purpose
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 Intervention Phase
Coronary Disease Procedure: single aorta clamp with retrograde cardioplegia Procedure: multiple aorta clamps with antegrade cardioplegia Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Estimated Enrollment: 300
Study Start Date: January 1999
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00059319


Locations
United States, North Carolina
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
  More Information

ClinicalTrials.gov Identifier: NCT00059319     History of Changes
Other Study ID Numbers: R01NS037242 ( U.S. NIH Grant/Contract )
First Submitted: April 23, 2003
First Posted: April 24, 2003
Last Update Posted: May 21, 2007
Last Verified: May 2007

Keywords provided by National Institute of Neurological Disorders and Stroke (NINDS):
coronary artery bypass graft surgery
CABG surgery
neurobehavioral impairment
aorta clamping
aorta manipulation
microemboli

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases