Reduced Manipulation of the Aorta and Neurobehavioral Outcome Trial

This study has been completed.
Sponsor:
Information provided by:
National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier:
NCT00059319
First received: April 23, 2003
Last updated: May 18, 2007
Last verified: May 2007
  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

Resource links provided by NLM:


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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059319

Locations
United States, North Carolina
Wake Forest University Baptist Medical Center
Winston Salem, North Carolina, United States, 27157
Sponsors and Collaborators
Investigators
Principal Investigator: John W. Hammon, M.D. Wake Forest School of Medicine
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00059319     History of Changes
Other Study ID Numbers: R01NS37242
Study First Received: April 23, 2003
Last Updated: May 18, 2007
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on July 23, 2014