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ROMA:Women Trial Summary
This trial will compare the outcomes of women who receive one arterial graft during CABG surgery (SAG) to those who receive multiple arterial grafts (MAG).
- Coronary Artery Disease
- Heart Disease
- Coronary Artery Bypass Surgery
ROMA:Women Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
ROMA:Women Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
ROMA:Women Trial Design
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Who is running the clinical trial?
- You have had a surgery called coronary artery bypass grafting.You have only had one organ transplant.You had a heart attack within 72 hours before the surgery.Your heart's pumping ability is very low.You have had any recent heart or non-heart surgeries.You have had heart surgery in the past.You have severe problems with your organs like kidneys, liver, or lungs, or any other serious health issues that may make your life shorter than 5 years.You can't use a specific vein for the procedure, or you can't use two specific arteries.You are expected to need a surgery called coronary thrombo-endarterectomy.You are scheduled to have a combination of different procedures to improve blood flow to your heart.You have had a specific type of heart surgery called isolated coronary artery bypass grafting.You have not had any heart surgeries before.You have a serious condition in the main arteries of your heart.You have a significant disease in certain main coronary arteries.
- Group 1: Single Arterial Graft (SAG) group
- Group 2: Multiple Arterial Graft (MAG) group
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Is there still an opportunity to join this research endeavor?
"Evidently, this trial is not currently seeking participants. Initially published on April 1st 2023 and last updated in October 2022, the study has been temporarily suspended from enrolling patients; however, there are 758 other trials actively recruiting at this moment."
In what locations is this scientific experiment being carried out?
"The Cleveland Clinic Foundation in Ohio, Lenox Hill Hospital of New York City, and the University of Colorado in Ohio, Lenox Hill Hospital of New York City, and the University of Colorado at Aurora are amongst the 24 medical centres involved with this clinical trial."
What are the principal aims of this clinical trial?
"The primary outcome of this clinical trial, monitored over a minimum 2.5 year period post-surgery, is the occurrence of death from any cause, stroke, non-procedural myocardial infarction (MI), repeat revascularization and hospital readmission for acute coronary syndrome or heart failure. Secondary measures include non-procedural MI based on the 4th Universal Definition, death due to any source with cardiac causes ruled out where possible, as well as generic quality of life determined by EuroQuol-5D's five dimensions: mobility; self care; usual activity; pain or discomfort; anxiety or depression; anxiety or depression."
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