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Arterial Grafting for Coronary Artery Disease(ROMA:Women Trial)

St. Boniface General Hospital, Winnipeg, Canada
Targeting 3 different conditionsSingle arterial graft +1 moreN/ARecruitingLed by Stephen Fremes, MDResearch Sponsored by Weill Medical College of Cornell University

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).

Eligible Conditions
  • Coronary Artery Disease
  • Heart Disease
  • Coronary Artery Bypass Surgery

ROMA:Women Trial Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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.

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
Secondary outcome measures
Death from any cause
Cerebral Revascularization
Cerebral Revascularization
+8 more
Other outcome measures
Other recorded outcomes (safety endpoints)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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
2,311 Previous Clinical Trials
3,386,507 Total Patients Enrolled
17 Trials studying Coronary Artery Disease
48,795 Patients Enrolled for Coronary Artery Disease
Oxford University Hospitals NHS TrustOTHER
206 Previous Clinical Trials
2,034,211 Total Patients Enrolled
6 Trials studying Coronary Artery Disease
23,976 Patients Enrolled for Coronary Artery Disease
Weill Medical College of Cornell UniversityLead Sponsor
1,039 Previous Clinical Trials
1,325,168 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 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; anxiety or depression."

Answered by AI
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~1333 spots leftby Mar 2030