Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass (ROOBY)
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| ClinicalTrials.gov Identifier: NCT00032630 |
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Recruitment Status :
Completed
First Posted : March 28, 2002
Results First Posted : January 10, 2014
Last Update Posted : May 5, 2014
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Ischemic Heart Disease | Procedure: Coronary artery bypass - on-pump Procedure: Coronary artery bypass - off-pump | Phase 3 |
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) use of 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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2203 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | CSP #517 - Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass |
| Study Start Date : | April 2002 |
| Actual Primary Completion Date : | April 2008 |
| Actual Study Completion Date : | April 2008 |
| Arm | Intervention/treatment |
|---|---|
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Arm 1
Coronary artery bypass - on-pump
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Procedure: Coronary artery bypass - on-pump
CABG procedure performed on heart lung machine |
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Arm 2
Coronary artery bypass - off-pump
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Procedure: Coronary artery bypass - off-pump
CABG procedure performed without the use of the heart lung machine |
- Short-term End Point [ Time Frame: 30 day ]Short-term end point was a composite of death or major complications (reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure requiring dialysis) occuring within 30 days after surgery or before discharge, whichever was later.
- Long-term Composite [ Time Frame: one-year ]Long-term composite endpoint was death from any cause within 1 year, nonfatal myocardial infarction between 30 days and 1 year, or repeat revascularization between 30 days and 1 year.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Elective or Urgent CABG
- CABG only procedure to be performed
Exclusion Criteria:
- Patient's surgeon is not a participant that meets study off-pup criteria
- Valve or Valve/CABG procedure
- Emergent, hemodynamically unstable, or in cardiogenic shock preoperatively
- Moderate, moderate, to severe, or severe valvular disease
- Enrolled in another therapeutic or interventional study
- Majority of diffusely diseased distal vessels
- Clinical Care Team has reservations
- History of on-compliance
- Patient preference for treatment arm
- Inability to provide informed consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00032630
Show 17 study locations
| Study Chair: | Frederick Grover, MD | VA Eastern Colorado Health Care System, Denver |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | US Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00032630 |
| Other Study ID Numbers: |
517 |
| First Posted: | March 28, 2002 Key Record Dates |
| Results First Posted: | January 10, 2014 |
| Last Update Posted: | May 5, 2014 |
| Last Verified: | April 2014 |
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Heart Diseases Myocardial Ischemia Coronary Artery Disease Cardiovascular Diseases |
Vascular Diseases Coronary Disease Arteriosclerosis Arterial Occlusive Diseases |