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NCT01924442 · ClinicalTrials.gov registry record
ROOBY Trial Follow-up Extension
A clinical trial, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- 2,203
- Enrollment target
NCT01924442: Completed study, sponsored by VA Office of Research and Development.
NCT01924442 is a clinical trial that has completed, run by VA Office of Research and Development. The registered enrollment target is 2,203 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01924442 has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- 2,203 participants
- Enrollment target
Study Summary
The Department of Veterans Affairs "Randomized On/Off Bypass" (ROOBY) Trial (CSP #517) was funded in 2001. ROOBY was designed to compare the short-term (30-day) and intermediate-term (1-year) outcomes for patients undergoing off-pump versus on-pump coronary artery bypass graft (CABG) procedures. The ROOBY trial reported a significantly higher 1-year adverse composite outcome rate (i.e., all-cause death, non-fatal myocardial infarction (MI) and/or repeat revascularization) for off-pump versus on-pump patients. ROOBY documented that a higher percentage of off-pump patients received fewer grafts than originally planned (i.e., off-pump patients were less completely revascularized) as compared to on-pump patients. Across all anatomic regions of the heart, the 1-year graft patency rates were significantly lower for off-pump CABG patients. Based on these ROOBY trial initial findings, critically important clinical questions related to the long-term efficacy, stability and durability of the off-pump versus on-pump techniques have been raised. Extending the original ROOBY trial, this CSP #517 follow-up study (CSP 517-FS) will evaluate the longer-term impact of off-pump versus on-pump surgical approaches upon the future occurrence of major adverse cardiovascular events (MACE).
Primary Outcome
Five-year mortality was initially assessed by matching the participants in the follow-up study to data in the VA Vital Status File and the National Death Index, which provided cause-of-death codes according to the International Classification of Diseases, 10th Revision.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,203 participants |
| Start Date | 2013-10-01 |
| Est. Completion | 2018-09-30 |
What the finished NCT01924442 record still lists
NCT01924442 is an observational study that tracks outcomes without assigning an intervention. Its 2,203 participants enrollment target places it among the larger protocols in the corpus.
The record links to 0 conditions, and to 0 interventions.
NCT01924442 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01924442 about?
NCT01924442 is a clinical study titled "ROOBY Trial Follow-up Extension". The Department of Veterans Affairs "Randomized On/Off Bypass" (ROOBY) Trial (CSP #517) was funded in 2001. ROOBY was designed to compare the short-term (30-day) and intermediate-term (1-year) outcomes for patients undergoing off-pump versus on-pump coronary artery bypass graft (CABG) procedures. The...
What is the current status of trial NCT01924442?
This trial is currently completed. The enrollment target is 2,203 participants. The study started on 2013-10-01. Estimated completion is 2018-09-30.
Who is sponsoring clinical trial NCT01924442?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
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