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Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass
This study is currently recruiting participants.
Verified by Department of Veterans Affairs, March 2007
Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00032630
  Purpose

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.


Condition Intervention Phase
Ischemic Heart Disease
Procedure: Coronary artery bypass - on-pump
Procedure: Coronary artery bypass - off-pump
Phase III

MedlinePlus related topics: Coronary Artery Bypass Surgery Heart Diseases
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: CSP #517 - Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 2200
Study Start Date: April 2002
Estimated Study Completion Date: November 2008
Detailed Description:

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

  • Elective or Urgent CABG
  • CABG only procedure to be performed
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00032630

Locations
United States, California
Vamc - Palo Alto, Ca Recruiting
Palo Alto, California, United States, 94304
Contact: John Giacomini, M.D.     650-493-5000 ext 65305     john.giacomini@med.va.gov    
Vamc - San Francisco, Ca Recruiting
San Francisco, California, United States, 94121
Contact: Mark Ratcliffe, M.D.     415-221-4810 ext 3451     mark.radcliffe@med.va.gov    
Vamc - Los Angeles, Ca Recruiting
Los Angeles, California, United States, 900073
Contact: Dennis Baker, MD     310-268-3445     dennis.baker@med.va.gov    
United States, Colorado
Vamc - Denver, Co Recruiting
Denver, Colorado, United States, 80220
Contact: Joseph Cleveland, Jr., M.D.     303-266-3855     joseph.cleveland@uchsc.edu    
United States, District of Columbia
Vamc - Washington, Dc Recruiting
Washington, District of Columbia, United States, 20422
Contact: Pendleton Alexander, M.D.     202-745-8626     epalexander@med.va.gov    
United States, Florida
Vamc - Miami, Fl Recruiting
Miami, Florida, United States, 33125
Contact: Richard J Thurer, MD     305-324-4455 ext 3244     richard.thurer@med.va.gov    
Vamc - Gainesville, Fl Recruiting
Gainesville, Florida, United States, 32608
Contact: Felipe Urdaneta, MD     352-376-1611 ext 6013        
Vamc - Tampa, Fl Recruiting
Tampa, Florida, United States, 33612
Contact: Dimitri Novitzky, M.D.     813-259-0626     dimitri.novitzky@med.va.gov    
United States, New Mexico
Vamc - Albuquerque, nm Terminated
Albuquerque, New Mexico, United States, 87108
United States, North Carolina
Vamc - Asheville, Nc Recruiting
Asheville, North Carolina, United States, 28805
Contact: John Lucke, M.D.     828-281-6024     john.lucke@med.va.gov    
Vamc - Durham, Nc Not yet recruiting
Durham, North Carolina, United States, 27705
Contact: Walter G Wolfe, MD            
United States, Ohio
Vamc - Cleveland, Oh Recruiting
Cleveland, Ohio, United States, 44106
Contact: Diana Whittlesey, M.D.     216-791-3800 ext 4288     diana.whittlesey@med.va.gov    
United States, Oregon
Vamc - Portland, or Recruiting
Portland, Oregon, United States, 97201
Contact: Pasala Ravichandran, M.D.     503-220-8262 ext 56916     pasala.ravichandran@med.va.gov    
United States, Pennsylvania
Vamc - Pittsburgh, Pa Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ali M Sonel, MD     412-688-6000 ext 5863     ali.sonel@med.va.gov    
United States, Texas
Vamc - Dallas, Tx Recruiting
Dallas, Texas, United States, 75216
Contact: John Sum-Ping, MD     214-857-1818     John.Sum-Ping@med.va.gov    
Vamc - San Antonio, Tx Recruiting
San Antonio, Texas, United States, 78284
Contact: Gregory Freeman, MD     210-617-5300     gregory.freeman@med.va.gov    
United States, Wisconsin
Vamc - Milwaukee, Wi Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Hossein Almassi, M.D.     414-557-8444     galmassi@mcw.edu    
Sponsors and Collaborators
  More Information

Study ID Numbers: 517
Study First Received: March 27, 2002
Last Updated: March 9, 2007
ClinicalTrials.gov Identifier: NCT00032630  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Heart Diseases
Myocardial Ischemia
Vascular Diseases
Ischemia

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009