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Compares treatment options for Heart Diseases
Official title Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women
ClinicalTrials.gov ID: NCT04124120
What this study is testing
- What it's testing
- The central hypothesis of ROMA:Women is that the use of multiple arterial grafting (MAG) will improve clinical outcomes and quality of life (QOL) compared to single arterial grafting (SAG). The specific aims of ROMA:Women are: Aim 1: Determine the impact of MAG vs SAG on major adverse cardiac and cerebrovascular events in women undergoing coronary artery bypass grafting (CABG).
- 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 and older, women only
You may be able to join if
- Women patients ≥18 years old.
- Isolated coronary artery bypass grafting.
- Primary (first time) cardiac surgery procedure.
- Significant disease of the left main coronary artery or of the left anterior descending and the circumflex coronary system with or without disease of...
You likely can't join if
- Male gender
- Single graft
- Emergency operation
- Myocardial infarction within 72 hours of surgery
- Left ventricular ejection fraction \< 35%
- Any concomitant cardiac or non-cardiac procedure
See the full eligibility criteria
- Women patients ≥18 years old.
- Isolated coronary artery bypass grafting.
- Primary (first time) cardiac surgery procedure.
- Significant disease of the left main coronary artery or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.
- Male gender
- Single graft
- Emergency operation
- Myocardial infarction within 72 hours of surgery
- Left ventricular ejection fraction \< 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 reduces 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
- Los Angeles, California, United States
- Pomona, California, United States
- San Francisco, California, United States
- Aurora, Colorado, United States
- Hartford, Connecticut, United States
- New Haven, Connecticut, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Indianapolis, Indiana, United States
- Iowa City, Iowa, United States
- Baltimore, Maryland, United States
- Springfield, Massachusetts, United States
- Worcester, Massachusetts, United States
- Ann Arbor, Michigan, United States
- Royal Oak, Michigan, United States
- St Louis, Missouri, United States
- Lincoln, Nebraska, United States
- Omaha, Nebraska, United States
- Englewood, New Jersey, United States
- Newark, New Jersey, United States
+ 114 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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 female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Pomona, California, United States; San Francisco, California, United States; Aurora, Colorado, United States; Hartford, Connecticut, United States; New Haven, Connecticut, United States and 128 more location(s). Enter your location above to see the nearest site and check your eligibility.
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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.