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Sponsored by: |
National Heart, Lung, and Blood Institute (NHLBI) |
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Information provided by: | National Heart, Lung, and Blood Institute (NHLBI) |
ClinicalTrials.gov Identifier: | NCT00000604 |
To compare three accepted modes of myocardial preservation, warm, tepid, and cold blood cardioplegia, coinciding with normothermic (37 degrees centigrade), tepid (32 degrees centigrade) and hypothermic (8 to 10 degrees centigrade) cardiopulmonary bypass (CPB) to define differences in neurologic function in coronary artery bypass graft (CABG) patients.
Condition | Intervention | Phase |
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Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Neurologic Manifestations |
Procedure: cardiopulmonary bypass Procedure: heart arrest, induced |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Study Start Date: | January 1994 |
Estimated Study Completion Date: | December 1996 |
BACKGROUND:
A pilot study of warm versus cold perfusion and preservation was completed in 32 patients prior to the ongoing study. The findings of the pilot study showed 53 percent of patients had evidence of new neurologic disturbance at postoperative day four. Only the neurologic dysfunction could be correlated with warm versus cold perfusion (37.5 percent warm versus 75 percent cold, P less than 0.05). The changes in neurologic function had abated or clearly improved by one month of follow-up, and the distinction in neurologic dysfunction grading was no longer apparent between the two groups.
DESIGN NARRATIVE:
Patients were randomly assigned to cold, tepid, or warm blood cardioplegia, coinciding with normothermic, tepid, and hypothermic cardiopulmonary bypass. All patients received a standard anesthetic protocol combining narcotic and inhalational anesthesia. Each patient entering the study had extensive clinical data collected prospectively incorporating most aspects of measurable determinants related to myocardial preservation. Additionally, neurologic tests were performed by a blinded neurologist and rated by an objective scoring system, the Mathew scale. The studies were performed preoperatively, on the third or fourth postoperative day, and at one month following surgery. Hematologic data were measured for fibrinolytic potential.
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Patients, referred for elective or urgent coronary revascularization, not having ongoing angina instability, requiring three or more bypass grafts, and under 70 years of age.
Study ID Numbers: | 108 |
Study First Received: | October 27, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00000604 |
Health Authority: | United States: Federal Government |
Arterial Occlusive Diseases Coronary Disease Signs and Symptoms Heart Diseases Myocardial Ischemia |
Vascular Diseases Neurologic Manifestations Arteriosclerosis Ischemia Coronary Artery Disease |
Pathologic Processes Nervous System Diseases Cardiovascular Diseases |