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Procedure

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

N/A

Waitlist Available

Led By Mario Gaudino, 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

Primary isolated CABG patients with disease of the left main coronary artery and/or of the left anterior descending and the circumflex coronary system with or without disease of the right coronary artery.

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up analysis will be performed after 631 events. the investigators assume this will occur at a mean follow-up of 5 years

Awards & highlights

ROMA Trial Summary

This trial is testing whether using multiple arterial grafts (2+) is better than using a single arterial graft for coronary artery bypass surgery in terms of reducing the composite outcome of death from any cause, any stroke, post discharge myocardial infarction and/or repeat revascularization.

Who is the study for?

This trial is for patients with coronary artery disease who need non-emergency heart bypass surgery and haven't had previous cardiac surgeries. It's not for those over 70, with recent heart attacks, severe heart failure, or other serious health issues that could limit life expectancy to under 5 years.Check my eligibility

What is being tested?

The ROMA trial is testing if using multiple arterial grafts in heart bypass surgery is better than a single graft at reducing death, strokes, heart attacks, and the need for more surgery. Patients are randomly assigned to either group in equal numbers across international centers.See study design

What are the potential side effects?

While specific side effects aren't listed here, typical risks of bypass surgery may include bleeding, infection, reactions to anesthesia, blood clots leading to stroke or lung problems; irregular heartbeat; and kidney problems.

ROMA Trial Eligibility Criteria

Inclusion Criteria

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

Select...

I have heart disease affecting specific arteries.

ROMA Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ analysis will be performed after 631 events. the investigators assume this will occur at a mean follow-up of 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~analysis will be performed after 631 events. the investigators assume this will occur at a mean follow-up of 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and analysis will be performed after 631 events. the investigators assume this will occur at a mean follow-up of 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Composite Outcome

Secondary outcome measures

30-day mortality

Heart

Composite Outcome of Death from any cause

+4 more

ROMA Trial Design

2Treatment groups

Experimental Treatment

Group I: Single Arterial 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 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 / 1Eligibility criteria met

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Who is running the clinical trial?

Weill Medical College of Cornell UniversityLead Sponsor

1,054 Previous Clinical Trials

1,312,345 Total Patients Enrolled

11 Trials studying Coronary Artery Disease

40,093 Patients Enrolled for Coronary Artery Disease

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,831 Previous Clinical Trials

47,299,454 Total Patients Enrolled

165 Trials studying Coronary Artery Disease

264,732 Patients Enrolled for Coronary Artery Disease

Canadian Institutes of Health Research (CIHR)OTHER_GOV

1,338 Previous Clinical Trials

25,747,218 Total Patients Enrolled

25 Trials studying Coronary Artery Disease

25,178 Patients Enrolled for Coronary Artery Disease

Media Library

Multiple Arterial Grafting (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT03217006 — N/A

Coronary Artery Disease Research Study Groups: Single Arterial Group, Multiple Arterial Group

Coronary Artery Disease Clinical Trial 2023: Multiple Arterial Grafting Highlights & Side Effects. Trial Name: NCT03217006 — N/A

Multiple Arterial Grafting (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03217006 — N/A

Frequently Asked Questions

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

Is this medical examination open to those in the senior age range?

"This trial is designed to study adults aged between 18 and 70. For those younger or older than that age range, there are 95 clinical trials for minors and 667 studies available for senior citizens."

Answered by AI

How many participants are currently accepted into the research trial?

"Affirmative. The information found on clinicaltrials.gov shows that recruitment for this experiment is ongoing, having been posted on July 1st 2018 and last updated April 19th 2022. 4300 participants are required from 18 different medical facilities to complete the study."

Answered by AI

How many medical facilities are engaged in the research project?

"This trial is presently recruiting from 18 different locations, which include major cities such as Pittsburgh, Boulder, and Springfield. To minimize travel requirements if accepted into the study, it's recommended to select a location near your current residence."

Answered by AI

Is it possible to enroll in this trial?

"This clinical study seeks 4300 individuals aged between 18 and 70 who suffer from coronary artery disease. Additionally, the participants should have primary isolated CABG with involvement of left main coronary artery and/or of the left anterior descending and circumflex coronary system (with or without right coronary artery issues)."

Answered by AI

Are there any opportunities to join this research initiative at the moment?

"Confirmed. Per the clinicaltrials.gov listing, this medical trial is presently recruiting patients with its first posting date as July 1st 2018 and most recent update occurring on April 19th 2022."

Answered by AI

Recent research and studies

CirculationJournal

2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery

Writing Committee Members, L. David Hillis, Peter K. Smith, Jeffrey L. Anderson, John A. Bittl, Charles R. Bridges, John G. Byrne, et al.. 2011. “2011 ACCF/AHA Guideline for Coronary Artery Bypass Graft Surgery”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/cir.0b013e31823c074e.

CirculationJournal

Relationship Between Vein Graft Failure and Subsequent Clinical Outcomes After Coronary Artery Bypass Surgery

Lopes, Renato D., Rajendra H. Mehta, Gail E. Hafley, Judson B. Williams, Michael J. Mack, Eric D. Peterson, Keith B. Allen, et al.. 2012. “Relationship Between Vein Graft Failure and Subsequent Clinical Outcomes After Coronary Artery Bypass Surgery”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.111.040311.

CirculationJournal

Arterial Versus Venous Bypass Grafts in Patients with In-stent Restenosis

Gaudino, Mario, Carlo Cellini, Claudio Pragliola, Carlo Trani, Francesco Burzotta, Giovanni Schiavoni, Giuseppe Nasso, and Gianfederico Possati. 2005. “Arterial Versus Venous Bypass Grafts in Patients with In-stent Restenosis”. Circulation. Ovid Technologies (Wolters Kluwer Health). doi:10.1161/circulationaha.104.512905.

New England Journal of MedicineJournal