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Procedure

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

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Isolated coronary artery bypass grafting

Primary (first time) cardiac surgery procedure

Must not have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up> 48 hours postoperatively, minimum 2.5 year follow-up

Awards & highlights

No Placebo-Only Group

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

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You have had a specific type of heart surgery called isolated coronary artery bypass grafting.

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You have not had any heart surgeries before.

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You have a serious condition in the main arteries of your heart.

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

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

+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.

0 / 3Eligibility criteria met

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

Recent research and studies

The Journal of Thoracic and Cardiovascular SurgeryJournal

Two Internal Thoracic Artery Grafts Are Better Than One

Lytle, Bruce W., Eugene H. Blackstone, Floyd D. Loop, Penny L. Houghtaling, John H. Arnold, Rami Akhrass, Patrick M. McCarthy, and Delos M. Cosgrove. 1999. “Two Internal Thoracic Artery Grafts Are Better Than One”. The Journal of Thoracic and Cardiovascular Surgery. Elsevier BV. doi:10.1016/s0022-5223(99)70365-x.

Journal of the American College of CardiologyJournal

2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery

Hillis, L. David, Peter K. Smith, Jeffrey L. Anderson, John A. Bittl, Charles R. Bridges, John G. Byrne, Joaquin E. Cigarroa, et al.. 2011. “2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery”. Journal of the American College of Cardiology. Elsevier BV. doi:10.1016/j.jacc.2011.08.009.

The Annals of Thoracic SurgeryJournal

Patencies of 2,127 Arterial to Coronary Conduits over 15 Years

Tatoulis, James, Brian F Buxton, and John A Fuller. 2004. “Patencies of 2,127 Arterial to Coronary Conduits over 15 Years”. The Annals of Thoracic Surgery. Elsevier BV. doi:10.1016/s0003-4975(03)01331-6.

European Journal of Cardio-Thoracic SurgeryJournal