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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

Must not have

Inability to use the saphenous vein or to use both radial and right internal thoracic arteries

Anticipated need for coronary thrombo-endarterectomy

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

No Placebo-Only Group

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I have heart disease affecting specific arteries.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot use my saphenous vein or both my radial and right internal thoracic arteries.

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I am expected to need surgery to remove blockages from my heart's arteries.

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I am undergoing or have undergone other heart or non-heart related surgeries.

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I do not have severe organ problems or other conditions that would shorten my life to under 5 years.

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I am scheduled for a combined surgical and non-surgical procedure to improve blood flow.

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I need an emergency surgery.

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I have not had a heart attack within 2 days before surgery.

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I have had heart surgery in the past.

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I am over 70 years old.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Composite Outcome

Secondary study objectives

30-day mortality

Heart

Composite Outcome of Death from any cause

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 10Eligibility criteria met