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Procedure

Single vs Multiple Arterial Grafts for Heart Disease (ROMA:Women Trial)

N/A
Recruiting
Led By Stephen Fremes, MD
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
Women patients ≥18 years old
Isolated coronary artery bypass grafting
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 below
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I am a woman aged 18 or older.
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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 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 weeks
Treatment ~ Varies
Follow Up ~> 48 hours postoperatively, minimum 2.5 year follow-up
This trial's timeline: 3 weeks for screening, Varies for treatment, and > 48 hours postoperatively, minimum 2.5 year follow-up for reporting.

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 more
Other 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
2,355 Previous Clinical Trials
3,407,041 Total Patients Enrolled
17 Trials studying Coronary Artery Disease
48,795 Patients Enrolled for Coronary Artery Disease
Oxford University Hospitals NHS TrustOTHER
208 Previous Clinical Trials
1,699,515 Total Patients Enrolled
6 Trials studying Coronary Artery Disease
23,976 Patients Enrolled for Coronary Artery Disease
Weill Medical College of Cornell UniversityLead Sponsor
1,052 Previous Clinical Trials
1,327,872 Total Patients Enrolled
11 Trials studying Coronary Artery Disease
42,393 Patients Enrolled for Coronary Artery Disease

Media Library

Multiple arterial grafting (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04124120 — N/A
Coronary Artery Disease Research Study Groups: Single Arterial Graft (SAG) group, Multiple Arterial Graft (MAG) group
Coronary Artery Disease Clinical Trial 2023: Multiple arterial grafting Highlights & Side Effects. Trial Name: NCT04124120 — N/A
Multiple arterial grafting (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04124120 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

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 at Aurora are amongst the 24 medical centres involved with this clinical trial."

Answered by AI

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."

Answered by AI
Recent research and studies
~1333 spots leftby Mar 2030