- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00032630
Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass (ROOBY)
CSP #517 - Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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California
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Palo Alto, California, Estados Unidos, 94304-1290
- VA Palo Alto Health Care System
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San Francisco, California, Estados Unidos, 94121
- VA Medical Center, San Francisco
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Sepulveda, California, Estados Unidos, 91343
- VA Greater Los Angeles HCS, Sepulveda
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Colorado
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Denver, Colorado, Estados Unidos, 80220
- VA Eastern Colorado Health Care System, Denver
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District of Columbia
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Washington, District of Columbia, Estados Unidos, 20422
- VA Medical Center, DC
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Florida
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Gainesville, Florida, Estados Unidos, 32608
- North Florida/South Georgia Veterans Health System
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Miami, Florida, Estados Unidos, 33125
- VA Medical Center, Miami
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Tampa, Florida, Estados Unidos, 33612
- James A. Haley Veterans Hospital, Tampa
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New Mexico
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Albuquerque, New Mexico, Estados Unidos, 87108-5153
- New Mexico VA Health Care System, Albuquerque
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North Carolina
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Asheville, North Carolina, Estados Unidos, 28805
- VA Medical Center, Asheville
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Durham, North Carolina, Estados Unidos, 27705
- VA Medical Center, Durham
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Ohio
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Cleveland, Ohio, Estados Unidos, 44106
- VA Medical Center, Cleveland
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Oregon
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Portland, Oregon, Estados Unidos, 97201
- VA Medical Center, Portland
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15240
- VA Pittsburgh Health Care System
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Texas
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Dallas, Texas, Estados Unidos, 75216
- VA North Texas Health Care System, Dallas
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San Antonio, Texas, Estados Unidos, 78229
- VA South Texas Health Care System, San Antonio
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53295-1000
- Zablocki VA Medical Center, Milwaukee
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: Arm 1
Coronary artery bypass - on-pump
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CABG procedure performed on heart lung machine
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Otro: Arm 2
Coronary artery bypass - off-pump
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CABG procedure performed without the use of the heart lung machine
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Short-term End Point
Periodo de tiempo: 30 day
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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.
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30 day
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Long-term Composite
Periodo de tiempo: one-year
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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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one-year
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Frederick Grover, MD, VA Eastern Colorado Health Care System, Denver
Publicaciones y enlaces útiles
Publicaciones Generales
- Shroyer AL, Grover FL, Hattler B, Collins JF, McDonald GO, Kozora E, Lucke JC, Baltz JH, Novitzky D; Veterans Affairs Randomized On/Off Bypass (ROOBY) Study Group. On-pump versus off-pump coronary-artery bypass surgery. N Engl J Med. 2009 Nov 5;361(19):1827-37. doi: 10.1056/NEJMoa0902905.
- Wagner TH, Hattler B, Bishawi M, Baltz JH, Collins JF, Quin JA, Grover FL, Shroyer AL; VA #517 Randomized On/Off Bypass (ROOBY) Study Group. On-pump versus off-pump coronary artery bypass surgery: cost-effectiveness analysis alongside a multisite trial. Ann Thorac Surg. 2013 Sep;96(3):770-7. doi: 10.1016/j.athoracsur.2013.04.074. Epub 2013 Aug 2.
- Hattler B, Carr BM, Messenger J, Spertus J, Ebrahimi R, Bishawi M, Quin JA, Almassi GH, Collins JF, Kozora E, Grover FL, Shroyer ALW. Clinical and Angiographic Predictors of Patient-Reported Angina 1 Year After Coronary Artery Bypass Graft Surgery. Circ Cardiovasc Qual Outcomes. 2019 Apr;12(4):e005119. doi: 10.1161/CIRCOUTCOMES.118.005119.
- Bishawi M, Hattler B, Almassi GH, Spertus JA, Quin JA, Collins JF, Grover FL, Shroyer AL; VA #517 Randomized On/Off Bypass (ROOBY) Study Group. Preoperative factors associated with worsening in health-related quality of life following coronary artery bypass grafting in the Randomized On/Off Bypass (ROOBY) trial. Am Heart J. 2018 Apr;198:33-38. doi: 10.1016/j.ahj.2017.12.014. Epub 2017 Dec 24.
- Almassi GH, Carr BM, Bishawi M, Shroyer AL, Quin JA, Hattler B, Wagner TH, Collins JF, Ravichandran P, Cleveland JC, Grover FL, Bakaeen FG; Veterans Affairs #517 Randomized On/Off Bypass (ROOBY) Study Group. Resident versus attending surgeon graft patency and clinical outcomes in on- versus off-pump coronary artery bypass surgery. J Thorac Cardiovasc Surg. 2015 Dec;150(6):1428-35, 1437.e1; discussion 1435-7. doi: 10.1016/j.jtcvs.2015.08.124. Epub 2015 Sep 18. Erratum In: J Thorac Cardiovasc Surg. 2016 Mar;151(3):895-6. J Thorac Cardiovasc Surg. 2016 Mar;151(3):895-896.
- Almassi GH, Wagner TH, Carr B, Hattler B, Collins JF, Quin JA, Ebrahimi R, Grover FL, Bishawi M, Shroyer AL; VA #517 Randomized On/Off Bypass (ROOBY) Study Group. Postoperative atrial fibrillation impacts on costs and one-year clinical outcomes: the Veterans Affairs Randomized On/Off Bypass Trial. Ann Thorac Surg. 2015 Jan;99(1):109-14. doi: 10.1016/j.athoracsur.2014.07.035. Epub 2014 Nov 6.
- Hattler B, Messenger JC, Shroyer AL, Collins JF, Haugen SJ, Garcia JA, Baltz JH, Cleveland JC Jr, Novitzky D, Grover FL; Veterans Affairs Randomized On/Off Bypass (ROOBY) Study Group. Off-Pump coronary artery bypass surgery is associated with worse arterial and saphenous vein graft patency and less effective revascularization: Results from the Veterans Affairs Randomized On/Off Bypass (ROOBY) trial. Circulation. 2012 Jun 12;125(23):2827-35. doi: 10.1161/CIRCULATIONAHA.111.069260. Epub 2012 May 16.
- Novitzky D, Baltz JH, Hattler B, Collins JF, Kozora E, Shroyer AL, Grover FL. Outcomes after conversion in the Veterans Affairs randomized on versus off bypass trial. Ann Thorac Surg. 2011 Dec;92(6):2147-54. doi: 10.1016/j.athoracsur.2011.05.122. Epub 2011 Oct 5.
- Zenati MA, Shroyer AL, Collins JF, Hattler B, Ota T, Almassi GH, Amidi M, Novitzky D, Grover FL, Sonel AF. Impact of endoscopic versus open saphenous vein harvest technique on late coronary artery bypass grafting patient outcomes in the ROOBY (Randomized On/Off Bypass) Trial. J Thorac Cardiovasc Surg. 2011 Feb;141(2):338-44. doi: 10.1016/j.jtcvs.2010.10.004. Epub 2010 Dec 3.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 517
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