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Outcomes following myocardial revascularization: on and off cardiopulmonary bypass Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Outcomes following myocardial revascularization: on and off cardiopulmonary bypass conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Outcomes following myocardial revascularization: on and off cardiopulmonary bypass Clinical research trials and Outcomes following myocardial revascularization: on and off cardiopulmonary bypass health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Outcomes following myocardial revascularization: on and off cardiopulmonary bypass. Outcomes following myocardial revascularization: on and off cardiopulmonary bypass Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Outcomes following myocardial revascularization: on and off cardiopulmonary bypass clinical trial. Human subjects often get the best healthcare available for their Outcomes following myocardial revascularization: on and off cardiopulmonary bypass condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "O" Clinical Trials Conditions > Outcomes following myocardial revascularization: on and off cardiopulmonary bypass  Outcomes following myocardial revascularization: on and off cardiopulmonary bypass
Outcomes following myocardial revascularization: on and off cardiopulmonary bypass
For Condition: Ischemic Heart Disease
Status: Recruiting
Sponsor(s): Department of Veterans Affairs , Department of Veterans Affairs Cooperative Studies Program
Synopsis: Ischemic heart disease is one of the most frequent diagnoses in the VA system. Moreover, 5,819 coronary artery bypass graft (CABG-only) procedures were performed in the VA in FY 1999. Throughout VA and non-VA cardiac surgery programs nationwide, myocardial revascularization is now being performed using two surgical techniques. One technique is performed with cardiopulmonary bypass (CPB) usually with cardioplegic arrest ("on-pump") and the other without CPB on a beating heart ("off-pump"). The overall purpose of this proposed randomized, controlled, clinical trial is to rigorously evaluate the impact of using an on-pump versus off-pump surgical technique for coronary artery bypass graft (CABG-only) procedures (performed with a traditional median sternotomy incision) upon patient clinical outcomes and resource utilization.
Details: Primary Hypotheses: The study has two primary hypotheses to evaluate the impact of using an off-pump versus an on-pump surgical technique for CABG procedures. One is a short term objective to assess the immediate impact of the two surgical techniques while the second assesses the long-term impact of the two techniques: 1) Short-Term Null Hypothesis: For patients having CABG-only procedures performed, there will be no difference in the short-term composite clinical outcome (30 day death or major morbidity) between patients randomized to the on-pump and off-pump procedures, 2) Long-Term Null Hypothesis: For patients undergoing CABG-only procedures, there will be no difference in long-term clinical outcome as measured by one year mortality and/or acute myocardial infarction prior to one year and/or a subsequent revascularization procedure within one year between patients randomized to the on-pump and off-pump procedures. Secondary Hypotheses: Major secondary objectives are to determine if there are differences in patients undergoing CABG-only procedures using the on-pump and off-pump techniques for 1) long-term completeness of revascularization, 2) one year graft patency and stenosis rates as determined by angiography at one year, and 3) short-term completeness of revascularization. Other secondary objectives are to evaluate the two surgical techniques on 1) changes in neuropsychological function, 2) traditional clinical outcomes, 3) general and disease specific quality of life, and 4) useof system resources. Intervention: Patients requiring an elective or urgent CABG-only (no other procedures to be done) surgical procedure will be randomized to either the off-pump procedure or to the on-pump procedure. Primary Outcomes: The short-term primary outcome measure is a composite measure of death, repeat cardiac surgery, new technical support, cardiac arrest, coma, prolonged stroke and/or renal failure requiring dialyses occurring within 30 days of surgery or prior to discharge, whichever is latest. The long-term primary outcome measure is a composite of death, acute myocardial infarction, and/or subsequent revascularization procedure prior to one year post-surgery. Study Abstract: Ischemic heart disease is one of the most frequent diagnoses in the VA system. Moreover, 5,819 coronary artery bypass graft (CABG-only) procedures were performed in the VA in FY 1999. Throughout VA and non-VA cardiac surgery programs nationwide, myocardial revascularization is now being performed using two surgical techniques. One technique is performed with cardiopulmonary bypass (CPB) usually with cardioplegic arrest ("on-pump") and the other without CPB on a beating heart ("off-pump"). The overall purpose of this proposed randomized, controlled, clinical trial is to rigorously evaluate the impact of using an on-pump versus off-pump surgical technique for coronary artery bypass graft (CABG-only) procedures (performed with a traditional median sternotomy incision) upon patient clinical outcomes and resource utilization.
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: - Elective or Urgent CABG - CABG only procedure to be performed
Total Enrollment: 2200
Location and Contact Information:
Vamc - Asheville, Nc *Recruiting*
Asheville, North Carolina, 28805
United States
Recruiting John Lucke 828-281-6024
Vamc - Cleveland, Oh *Recruiting*
Cleveland, Ohio, 44106
United States
Recruiting Diana Whittlesey 216-791-3800
Vamc - Miami, Fl *Recruiting*
Miami, Florida, 33125
United States
Recruiting Richard Thurer 305-324-4455
Vamc - San Antonio, Tx *Recruiting*
San Antonio, Texas, 78284
United States
Recruiting Gregory Freeman 210-617-5300
Vamc - Portland, Or *Suspended*
Portland, Oregon, 97201
United States
Suspended
Vamc - Milwaukee, Wi *Recruiting*
Milwaukee, Wisconsin, 53226
United States
Recruiting Hossein Almassi 414-557-8444
Vamc - Denver, Co *Recruiting*
Denver, Colorado, 80220
United States
Recruiting Joseph Cleveland 303-266-3855
Vamc - Tampa, Fl *Recruiting*
Tampa, Florida, 33612
United States
Recruiting Dimitri Novitzky 813-259-0626
Vamc - Dallas, Tx *Recruiting*
Dallas, Texas, 75216
United States
Recruiting Philip Greilich 214-857-1817
Vamc - Washington, Dc *Recruiting*
Washington D.C., District of Columbia, 20422
United States
Recruiting Pendleton Alexander 202-745-8626
Vamc - San Francisco, Ca *Recruiting*
San Francisco, California, 94121
United States
Recruiting Mark Ratcliffe 415-221-4810
Vamc - Palo Alto, Ca *Recruiting*
Palo Alto, California, 94304
United States
Recruiting John Giacomini 650-493-5000
Vamc - Los Angeles, Ca *Recruiting*
Los Angeles, California, 900073
United States
Recruiting Edward Livingston 310-268-3525
Vamc - Pittsburgh, Pa *Recruiting*
Pittsburgh, Pennsylvania, 15213
United States
Recruiting Ali Sonel 412-688-6000
Vamc - Albuquerque, Nm *Recruiting*
Albuquerque, New Mexico, 87108
United States
Recruiting Sarah Vernon 505-265-1711
Vamc - Gainesville, Fl *Recruiting*
Gainesville, Florida, 32608
United States
Recruiting Felipe Urdaneta 352-376-1611
Additional Information:
Study ID Numbers: 517;
Study Start Date: April 2002
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00032630
Other Ischemic Heart Disease Studies:
1. Warfarin versus Aspirin in Reduced Cardiac Ejection Fraction (WARCEF) Trial
2. Quality of Life in Patients with Chronic Ischemic Heart Disease
3. Outcomes following myocardial revascularization: on and off cardiopulmonary bypass
Related Studies:
Other Ischemic Heart Disease Clinical Trials
Other Pennsylvania Clinical Trials
Other Pittsburgh Clinical Trials
Outcomes following myocardial revascularization: on and off cardiopulmonary bypass
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