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Outcomes Following Myocardial Revascularization: On and Off Cardiopulmonary Bypass (ROOBY)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00032630
First received: March 27, 2002
Last updated: April 18, 2014
Last verified: April 2014
Results First Received: August 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Treatment
Condition: Ischemic Heart Disease
Interventions: Procedure: Coronary artery bypass - on-pump
Procedure: Coronary artery bypass - off-pump

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
From February 2002 to May 2007, a total of 9663 patients who were scheduled for urgent or elective Coronary Artery Bypass Graft (CABG) were screened for enrollment. Of these, 7460 patients were excluded, mostly because of diffusely diseased or small coronary arteries. Overall,1099 patients were randomized to on-pump and 1104 randomized to off-pump

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
On Pump Coronary artery bypass performed on a non beating heart using a heart-lung machine
Off Pump Coronary artery bypass performed on a beating heart with no heart-lung machine

Participant Flow:   Overall Study
    On Pump     Off Pump  
STARTED     1099     1104  
COMPLETED     1050     1061  
NOT COMPLETED     49     43  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
On Pump Coronary artery bypass performed on a non beating heart using a heart-lung machine
Off Pump Coronary artery bypass performed on a beating heart with no heart-lung machine
Total Total of all reporting groups

Baseline Measures
    On Pump     Off Pump     Total  
Number of Participants  
[units: participants]
  1099     1104     2203  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     699     671     1370  
>=65 years     400     433     833  
Age  
[units: years]
Mean ± Standard Deviation
  62.5  ± 8.5     63.0  ± 8.5     62.74  ± 8.49  
Gender  
[units: participants]
     
Female     6     7     13  
Male     1093     1097     2190  
Region of Enrollment  
[units: participants]
     
United States     1099     1104     2203  



  Outcome Measures
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1.  Primary:   Short-term End Point   [ Time Frame: 30 day ]

2.  Primary:   Long-term Composite   [ Time Frame: one-year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Frederick Grover, MD
Organization: VA Medical Center, Denver, Colorado
phone: 303-393-2863
e-mail: Frederick.Grover@ucdenver.edu


Publications of Results:
Publications automatically indexed to this study:

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00032630     History of Changes
Other Study ID Numbers: 517
Study First Received: March 27, 2002
Results First Received: August 8, 2013
Last Updated: April 18, 2014
Health Authority: United States: Federal Government