All Cause Mortality Clinical Trial
Official title:
CSP #517-FS - ROOBY Trial Extension (Randomized on Pump and Off Pump Bypass Surgery: Long Term Follow-up)
NCT number | NCT01924442 |
Other study ID # | 517-FS |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2013 |
Est. completion date | September 30, 2018 |
Verified date | March 2019 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 2203 |
Est. completion date | September 30, 2018 |
Est. primary completion date | September 1, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - All patients that survived to 1 year enrolled in the ROOBY Trial Exclusion Criteria: - None |
Country | Name | City | State |
---|---|---|---|
United States | Northport VA Medical Center, Northport, NY | Northport | New York |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Long-term All Cause Mortality Between On-pump and Off-pump Patients. | 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. | 5 Years | |
Secondary | Long-term Major Adverse Cardiovascular Event (MACE) Between On-pump and Off-pump Patients | Secondary outcomes included the 5-year rates of death from cardiac causes, repeat revascularization and nonfatal myocardial infarction. | 5 years |
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