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Single vs Multiple Arterial Grafts for Heart Disease (ROMA:Women Trial)
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).
ROMA:Women Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowROMA:Women Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.ROMA:Women Trial Design
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Who is running the clinical trial?
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- I have had heart surgery in the past.I am a woman aged 18 or older.I have had surgery to improve blood flow to my heart.I am male.I do not have severe organ problems or other health issues that could shorten my life to under 5 years.I am scheduled for a combined surgical and non-surgical procedure to improve blood flow.I cannot use my saphenous vein or both my radial and right internal thoracic arteries.I have severe heart artery disease affecting the main or left arteries.I am a woman aged 18 or older.I need an emergency surgery.I had a heart attack less than 3 days before my surgery.I am undergoing or have undergone other heart or non-heart related surgeries.Your heart's pumping ability is too low.I am expected to need surgery to remove blockages from my heart's arteries.I am having my first heart surgery.Only one transplant is allowed.I am having my first heart surgery.I have had surgery to improve blood flow to my heart.I have severe heart artery disease affecting the main or major side 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."
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."
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