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Tracking Information | |||||
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First Received Date ICMJE | April 23, 2003 | ||||
Last Updated Date | May 18, 2007 | ||||
Start Date ICMJE | January 1999 | ||||
Current Primary Outcome Measures ICMJE | |||||
Original Primary Outcome Measures ICMJE | |||||
Change History | Complete list of historical versions of study NCT00059319 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE | |||||
Original Secondary Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Reduced Manipulation of the Aorta and Neurobehavioral Outcome Trial | ||||
Official Title ICMJE | |||||
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. |
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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. |
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Study Phase | Phase III | ||||
Study Type ICMJE | Interventional | ||||
Study Design ICMJE | Treatment, Randomized | ||||
Condition ICMJE | Coronary Disease | ||||
Intervention ICMJE |
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Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 300 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria ICMJE |
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Gender | Both | ||||
Ages | 50 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID ICMJE | NCT00059319 | ||||
Responsible Party | |||||
Study ID Numbers ICMJE | R01NS37242 | ||||
Study Sponsor ICMJE | National Institute of Neurological Disorders and Stroke (NINDS) | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | National Institute of Neurological Disorders and Stroke (NINDS) | ||||
Verification Date | May 2007 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |