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Compares treatment options for Coronary Artery Disease
Official title Randomization of Single vs Multiple Arterial Grafts
ClinicalTrials.gov ID: NCT03217006
What this study is testing
- What it's testing
- The primary hypothesis of ROMA is that in patients undergoing primary isolated non-emergent coronary artery bypass surgery (CABG), the use of two or more arterial grafts compared to a single arterial graft is associated with a reduction in the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization. The secondary hypothesis is that in patients undergoing primary isolated non-emergent CABG, the use of two or more arterial grafts compared to a single arterial graft is associated with improved survival.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Primary isolated CABG patients with disease of the left main coronary artery and/or of the left anterior descending and the circumflex coronary...
You likely can't join if
- Age \> 70 years
- Single graft
- Emergency operation
- Evolving myocardial infarction within 48 hours of surgery
- Left ventricular ejection fraction of \< 35%
- Any concomitant cardiac or non-cardiac procedure
See the full eligibility criteria
- Primary isolated CABG patients with disease of the left main coronary artery and/or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.
- Age \> 70 years
- Single graft
- Emergency operation
- Evolving myocardial infarction within 48 hours of surgery
- Left ventricular ejection fraction of \< 35%
- Any concomitant cardiac or non-cardiac procedure
- Previous cardiac surgery
- Preoperative severe end-organ dysfunction (dialysis, liver failure, respiratory failure), cancer or any co-morbidity that reduce life expectancy to less than 5 years.
- Inability to use the saphenous vein or to use both radial and right internal thoracic arteries
- Anticipated need for coronary thrombo-endarterectomy
- Planned hybrid revascularization
The study team makes the final eligibility decision.
Where it's taking place
- Boulder, Colorado, United States
- Springfield, Massachusetts, United States
- Lincoln, Nebraska, United States
- Omaha, Nebraska, United States
- Brooklyn, New York, United States
- New York, New York, United States
- Cleveland, Ohio, United States
- Pittsburgh, Pennsylvania, United States
- Innsbruck, Austria
- Vienna, Austria
- São Paulo, Brazil
- Hamilton, Canada
- London, Canada
- Montreal, Canada
- Ottawa, Canada
- Québec, Canada
- Toronto, Canada
- Winnipeg, Canada
- Beijing, China
- Changchun, China
+ 32 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boulder, Colorado, United States; Springfield, Massachusetts, United States; Lincoln, Nebraska, United States; Omaha, Nebraska, United States; Brooklyn, New York, United States; New York, New York, United States and 46 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.