Ischemic Heart DiseasePhase 3ROOBYNCT00032630
Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass
A Phase 3 study testing Coronary artery bypass - on-pump and Coronary artery bypass - off-pump in people with Ischemic Heart Disease, run by US Department of Veterans Affairs at 17 sites in United States.
Trial summary
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 Fiscal Year (FY) 1999. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- Coronary artery bypass - on-pump and Coronary artery bypass - off-pump
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,203 participants
- Where
- 17 sitesUnited States
- Study dates
- Apr 2002to Apr 2008
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Elective or Urgent CABG
- CABG only procedure to be performed
Who cannot join
- 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
Show all 10Show fewer
- Clinical Care Team has reservations
- History of on-compliance
- Patient preference for treatment arm
- Inability to provide informed consent
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
New Mexico VA Health Care System, Albuquerque
Albuquerque, New Mexico, 87108-5153
VA Medical Center, Asheville
Asheville, North Carolina, 28805
VA Medical Center, Cleveland
Cleveland, Ohio, 44106
VA North Texas Health Care System, Dallas
Dallas, Texas, 75216
VA Eastern Colorado Health Care System, Denver
Denver, Colorado, 80220
VA Medical Center, Durham
Durham, North Carolina, 27705
North Florida/South Georgia Veterans Health System
Gainesville, Florida, 32608
VA Medical Center, Miami
Miami, Florida, 33125
Zablocki VA Medical Center, Milwaukee
Milwaukee, Wisconsin, 53295-1000
VA Palo Alto Health Care System
Palo Alto, California, 94304-1290
VA Pittsburgh Health Care System
Pittsburgh, Pennsylvania, 15240
VA Medical Center, Portland
Portland, Oregon, 97201
VA South Texas Health Care System, San Antonio
San Antonio, Texas, 78229
VA Medical Center, San Francisco
San Francisco, California, 94121
VA Greater Los Angeles HCS, Sepulveda
Sepulveda, California, 91343
James A. Haley Veterans Hospital, Tampa
Tampa, Florida, 33612
VA Medical Center, DC
Washington D.C., District of Columbia, 20422
About this study
Official title: CSP #517 - Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass
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 Fiscal Year (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.
Read the 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) 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.
- Conditions
- Ischemic Heart Disease
- Being tested
- Coronary artery bypass - on-pump, Coronary artery bypass - off-pump
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary artery bypass - on-pumpProcedure or surgery
CABG procedure performed on heart lung machine
Coronary artery bypass - off-pumpProcedure or surgery
CABG procedure performed without the use of the heart lung machine
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Other | Coronary artery bypass - on-pump Receives: Procedure: Coronary artery bypass - on-pump |
| Arm 2 | Other | Coronary artery bypass - off-pump Receives: Procedure: Coronary artery bypass - off-pump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term End Point
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.
Measured: 30 day
Long-term Composite
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.
Measured: one-year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2002 (estimated)
- Study startApr 2002
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2,203 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Frederick Grover, MD, Study chair, VA Eastern Colorado Health Care System, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00032630
- Sponsor's protocol ID
- 517
- Acronym
- ROOBY
- Status last verified
- Apr 2014
- First submitted
- 27 Mar 2002
- Last updated
- 5 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
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.
PubMed 19890125Wagner 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.
PubMed 23916805Hattler 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.
PubMed 31001997Bishawi 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.
PubMed 29653645Almassi 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.
PubMed 26470910Almassi 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.
PubMed 25442992Hattler 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.
PubMed 22592900Novitzky 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.
PubMed 21978872Zenati 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.
PubMed 21130476
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CSP #517 - Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT00032630
- Acronym / sponsor ID
- ROOBY / 517
- Conditions
- Ischemic Heart Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,203 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Apr 2002
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 28 Mar 2002 (estimated)
- Results
- Posted 10 Jan 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Fiscal Year (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.
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) 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Other | Procedure: Coronary artery bypass - on-pumpCoronary artery bypass - on-pump |
| Arm 2 | Other | Procedure: Coronary artery bypass - off-pumpCoronary artery bypass - off-pump |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Elective or Urgent CABG
- CABG only procedure to be performed
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Coronary artery bypass - on-pumpCABG procedure performed on heart lung machine | Procedure or surgery | Arm 1 |
| Coronary artery bypass - off-pumpCABG procedure performed without the use of the heart lung machine | Procedure or surgery | Arm 2 |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19890125Shroyer 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.
- Results publication: PubMed 23916805Wagner 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.
- Derived from this study: PubMed 31001997Hattler 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.
- Derived from this study: PubMed 29653645Bishawi 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.
- Derived from this study: PubMed 26470910Almassi 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.
- Derived from this study: PubMed 25442992Almassi 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.
- Derived from this study: PubMed 22592900Hattler 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.
- Derived from this study: PubMed 21978872Novitzky 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.
- Derived from this study: PubMed 21130476Zenati 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frederick Grover, MD study chair
VA Eastern Colorado Health Care System, Denver
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Coronary artery bypass - on-pump and Coronary artery bypass - off-pump in people with Ischemic Heart Disease, run by US Department of Veterans Affairs at 17 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Short-term End Point (time frame: 30 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00032630, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2014.