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Procedure
Single vs Multiple Arterial Grafts for Heart Disease (ROMA:Women Trial)
N/A
Recruiting
Led By Ruth Masterson Creber, RN, PhD
Research Sponsored by Weill Medical College of Cornell University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Isolated coronary artery bypass grafting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up > 48 hours postoperatively, minimum 2.5 year follow-up
Awards & highlights
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).
Who is the study for?
This trial is for women over 18 facing their first heart surgery due to significant coronary artery disease. They must not have had previous cardiac surgeries, recent heart attacks, severe heart failure, or other serious health issues that could limit life expectancy.Check my eligibility
What is being tested?
The study compares the effectiveness of using multiple arterial grafts (MAG) versus a single arterial graft (SAG) in women undergoing bypass surgery. It aims to see if MAG can better prevent major heart and brain events and improve quality of life.See study design
What are the potential side effects?
While specific side effects are not listed, typical risks may include complications from surgery such as infection, bleeding, stroke, or adverse reactions to anesthesia.
ROMA:Women Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had surgery to improve blood flow to my heart.
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I have severe heart artery disease affecting the main or left arteries.
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I am a woman aged 18 or older.
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I am having my first heart surgery.
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I am having my first heart surgery.
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I have had surgery to improve blood flow to my heart.
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I have severe heart artery disease affecting the main or major side arteries.
ROMA:Women Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ > 48 hours postoperatively, minimum 2.5 year follow-up
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~> 48 hours postoperatively, minimum 2.5 year follow-up
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Cerebral Revascularization
Disease
Secondary outcome measures
Death from any cause
Cerebral Revascularization
Cerebral Revascularization
+8 moreOther outcome measures
Other recorded outcomes (safety endpoints)
ROMA:Women Trial Design
2Treatment groups
Experimental Treatment
Group I: Single Arterial Graft (SAG) groupExperimental Treatment1 Intervention
Patients in this group will receive a single arterial graft which will be the left internal thoracic artery. Additional grafts used in this group will all be venous grafts.
Group II: Multiple Arterial Graft (MAG) groupExperimental Treatment1 Intervention
Patients in the group will receive multiple arterial grafts. All patients will receive at least two arterial grafts, the left internal thoracic artery with the addition of either the right internal thoracic artery or the radial artery as the second conduit. Some patients may receive additional arterial grafts consisting of the radial artery, the right internal thoracic artery, or the right gastroepiploic artery.
Find a Location
Who is running the clinical trial?
Duke UniversityOTHER
2,384 Previous Clinical Trials
3,425,322 Total Patients Enrolled
17 Trials studying Coronary Artery Disease
48,795 Patients Enrolled for Coronary Artery Disease
Oxford University Hospitals NHS TrustOTHER
212 Previous Clinical Trials
1,698,929 Total Patients Enrolled
6 Trials studying Coronary Artery Disease
23,976 Patients Enrolled for Coronary Artery Disease
Weill Medical College of Cornell UniversityLead Sponsor
1,061 Previous Clinical Trials
1,314,377 Total Patients Enrolled
14 Trials studying Coronary Artery Disease
43,643 Patients Enrolled for Coronary Artery Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Single Arterial Graft (SAG) group
- Group 2: Multiple Arterial Graft (MAG) group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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.
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