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VA Cooperative Studies Program (CSP)

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CSP #517: Randomized On/Off Cardiopulmonary Bypass (ROOBY) Trial & Follow-Up Extension

Main study:
CSP #517: Randomized On/Off Cardiopulmonary Bypass (ROOBY) Trial

Follow-Up Extension: 
CSP #517-FS: ROOBY Trial Follow-Up Extension  

Data Sharing Statement
CSP #517: ROOBY Trial

What's available

Research data

Available Documentation 

  • Data dictionary
  • Study protocol
  • Statistical analysis plan
  • Questionnaires
  • Analytic code

Dates Data are Available 

Expected in 2022 (5 years after publication of CSP #517-FS main manuscript: Five-year outcomes after on-pump and off-pump coronary-artery bypass)

Access Criteria

Investigators associated with VA or non-VA nonprofit, academic, or research institutions may submit a Research Resource Request form to Kousick.Biswas@va.gov.

Investigators may be asked to provide further documentation such as a study proposal. All requests are reviewed for scientific and ethical merit. Access is contingent upon approval by the requestor’s Institutional Review Board (IRB) and, if applicable, a VA Research and Development (R&D) Committee. To gain access, requestors must sign a VA data use agreement. Requestors must be fully compliant with VA data security, privacy, and human subjects requirements.

Study Characteristics
CSP #517: ROOBY Trial

Objectives

To evaluate the impact of an on-pump versus off-pump surgical technique for coronary artery bypass graft (CABG)-only procedures through short-term and long-term patient clinical outcomes and resource utilization

Era of Service

All

Population

  • Patients of VA medical centers scheduled for urgent or elective CABG-only procedures
  • Predominantly male (99.4%)

Study Design 

Single-blind, randomized controlled clinical trial

Intervention 

  • Arm 1, On-pump: CABG procedure performed on a non-beating heart using a heart-lung machine
  • Arm 2, Off-pump: CABG procedure performed on a beating heart without the use of heart lung-machine

Time Period 

February 2002 - May 2008

Setting 

National 

2,203

  • On-pump: 1,099
  • Off-pump: 1,104

Response Rate

N/A

Recruitment Method

Patients who were scheduled for urgent or elective CABG-only procedures were screened for enrollment. Eligible patients whose surgeons were participating in the study and provided consent were enrolled by a site coordinator.

Compensation

None

Data Collected

Primary outcomes

  • 30-day short-term endpoint was a composite of death and major complications (reoperation, new mechanical support, cardiac arrest, coma, stroke, or renal failure)
  • 1-year long-term endpoint was a composite of death from any cause, repeat revascularization procedure between 30 days and 1 year, and nonfatal myocardial infarction between 30 days and 1 year 

Secondary outcomes

  • Completeness of revascularization
  • Graft patency at 1 year
  • Changes in neuropsychological function
  • Traditional clinical outcomes
  • General and disease-specific quality of life
  • Use of system resources (e.g., operating room times, rehospitalization)

Other assessments

  • Demographics
  • Medical history
  • Smoking status
  • Coexisting conditions

Data Collection Method

  • VA death registry (for long-term, 1-year survival status)
  • Angiograms (for secondary endpoints)
  • Neuropsychological testing (for secondary endpoints)

Funding Source

VA Cooperative Studies Program (CSP)

Contact 

Kousick.Biswas@va.gov

Selected Publications 

Novitzky D, Shroyer AL, Collins JF, McDonald GO, Lucke J, Hattler B, Kozora E, Bradham DD, Baltz J, Grover FL; ROOBY Study Group. A study design to assess the safety and efficacy of on-pump versus off-pump coronary bypass grafting: the ROOBY trial. Clin Trials. 2007;4(1):81-91. 

Shroyer AL, Grover FL, Hattler, B, Collins JF, McDonald GO, Kozora E, Lucke JC, Baltz JH, Novitzky D, ROOBY Study Group. On-pump versus off-pump coronary-artery bypass surgery. N Engl J Med. 2009;361(19):1827-37. 

Bishawi M, Shroyer AL, Rumsfeld JS, Spertus JA, Baltz JH, Collins JF, Quin JA, Almassi GH, Grover FL, Hattler B, ROOBY Study Group. Changes in health-related quality of life in off-pump versus on-pump cardiac surgery: Veterans Affairs randomized on/off bypass trial. Ann Thorac Surg. 2013;95:1946-51. 

Kozora MA, Kongs S, Collins JF, Hattler B, Baltz J, Hampton M, Grover FL, Novitzky D, Shroyer al. Cognitive outcomes following On-versus Off-pump coronary artery bypass surgery. Annals of Thoracic Surgery. 2010; 90: 1134-1141.

More Information 

Study ClinicalTrials.gov site
ClinicalTrials.gov Identifier: NCT00032630
CSP #517-FS: ROOBY Trial: Follow-Up Extension (below)



  

Data Sharing Statement
CSP #517-FS: ROOBY Trial Follow-Up Extension

What's available

Research data

Available Documentation 

Study protocol & statistical analysis plan available in full text of Five-year outcomes after on-pump and off-pump coronary-artery bypass

Dates Data are Available 

Expected in 2022 (5 years after publication of CSP #517-FS main manuscript: Five-year outcomes after on-pump and off-pump coronary-artery bypass)  

Access Criteria

Investigators associated with VA or non-VA nonprofit, academic, or research institutions may submit a Research Resource Request form to Kousick.Biswas@va.gov.

Investigators may be asked to provide further documentation such as a study proposal. All requests are reviewed for scientific and ethical merit. Access is contingent upon approval by the requestor’s Institutional Review Board (IRB) and, if applicable, a VA Research and Development (R&D) Committee. To gain access, requestors must sign a VA data use agreement. Requestors must be fully compliant with VA data security, privacy, and human subjects requirements.

Study Characteristics
CSP #517-FS: ROOBY Trial Follow-Up Extension

Objectives

To examine the longer-term (5-year) clinical outcomes in patients who had undergone randomization in the original Randomized On/Off Cardiopulmonary Bypass (ROOBY) Trial

Era of Service

All

Population

All participants from the CSP #517: ROOBY Trial who survived to 1 year

Study Design 

Prospective cohort study

Time Period 

October 2013 - October 2017 

Setting

National

2,203 (2,026 included in 5-year mortality and morbidity sensitivity analysis)

Response Rate

Follow-up data available for 99.5% of all patients from original ROOBY Trial

Recruitment Method

There was no contact with any of the ROOBY Trial patients. The study obtained IRB-approved waivers of informed consent and HIPAA authorizations to gather patient data.

Compensation

None

Data Collected

Primary outcomes

  • Death from any cause
  • Composite outcome of major adverse cardiovascular events (MACE), defined as death from any cause, repeat revascularization (CABG or percutaneous coronary intervention), or nonfatal myocardial infarction 

Secondary outcomes

  • Death from cardiac causes
  • Repeat revascularization
  • Nonfatal myocardial infarction
  • Composite outcome of death from cardiac causes, repeat revascularization, or nonfatal myocardial infarction

Data Collection Method

VA and non-VA electronic databases, including but not limited to VA medical records, VA National Data Systems, Medicare, Medicaid, National Death Index

Funding Source

VA Cooperative Studies Program (CSP)

Contact 

Kousick.Biswas@va.gov

Selected Publications 

Shroyer AL, Hattler B, Wagner TH, Collings, Baltz JH, Quin JA, Almassi GH, Kozora E, Bakaeen F, Cleveland JC Jr, Bishawi M, Grover FL, ROOBY-FS Group. Five-year outcomes after on-pump and off-pump coronary-artery bypass. N Engl J Med. 2017 Aug;377(7):623-32.

Quin JA, Hattler B, Shroyer AL, Kemp D, Almassi GH, Bakaeen FG, Carr BM, Bishawi M, Collins JF, Grover FL Wagner TH. Concordance between administrative data and clinical review for mortality in the randomized on/off pump bypass follow-up study (ROOBY-FS). Journal of Cardiac Surgery. 2017; 32: 751-756.

More Information 

Study ClinicalTrials.gov site
ClinicalTrials.gov Identifier: NCT01924442