RecruitingNAINTERVENTIONAL

Randomization of Single vs Multiple Arterial Grafts

This research study, called ROMA, is looking into how best to perform a type of heart surgery called coronary artery bypass surgery (CABG). During this surgery, doctors use healthy blood vessels (grafts) to bypass blocked ones in your heart. The study wants to find out if using two or more of these special arterial grafts is better than using just one. They will compare these two approaches to see if using more grafts can reduce serious problems like death, stroke, future heart attacks, or the need for more heart procedures. It's a large, international study involving many patients to make sure the results are accurate and helpful for future heart patients.

At a glance

Status

Recruiting

Phase

Sponsor

Weill Medical College of Cornell University

Enrolment target

4,300

Start

07 Jan 2018

Estimated completion

01 Jan 2030

Coronary Artery Disease Heart Diseases

What is this study about?

Imagine your heart has blood vessels (like tiny pipes) that deliver blood. If these pipes get blocked, your heart doesn't get enough blood, which can lead to problems. Coronary artery bypass surgery (CABG) is a way to create new paths for blood to flow around these blockages, using healthy blood vessels taken from elsewhere in your body, called grafts.

For many years, doctors have known that certain types of grafts, especially those taken from an artery in the chest (called the internal thoracic artery), tend to work better and last longer than other grafts, like vein grafts. More recently, studies have suggested that using two or more of these high-quality arterial grafts, instead of just one, might offer even better long-term benefits for patients. However, we need a very robust study to confirm this definitively.

That's where the ROMA study comes in. It's a major research project set up to directly compare these two approaches: using one arterial graft versus using two or more. The main goal is to see if using more arterial grafts can help patients live longer, reduce the chance of having a stroke or another heart attack after surgery, or avoid needing more heart procedures in the future. The study hopes to provide clear answers to help doctors decide the best way to perform this important surgery.

Key takeaways

This study compares using one vs. two or more arterial grafts in heart bypass surgery.
It aims to find out if more grafts lead to better long-term health outcomes.
Participation involves being randomly assigned to one of the two surgery approaches.
The study focuses on reducing death, stroke, heart attacks, or future procedures.
It's for adults 18-70 needing their first non-emergency bypass surgery.
Long-term follow-up is a key part of participating in the study.

Who may be eligible?

This study is for adults generally aged 18 to 70 who need their first-ever heart bypass surgery. This surgery must be planned and not for an emergency situation. You would be considered if you have blockages in certain main heart arteries, specifically the left main artery, the left anterior descending artery, or the circumflex system, possibly with issues in the right coronary artery too.

There are several reasons you might not be able to join. For example, if you are over 70, if you need emergency surgery, or if you've recently had a heart attack (within 48 hours) as this can make surgery more complicated. Also, if you've already had heart surgery before, or if you have other serious health problems like kidney, liver, or breathing failure, or certain types of cancer that significantly shorten your life expectancy, you wouldn't be eligible.

Additionally, patients with very weak heart muscle (a low 'ejection fraction' below 35%), or those who need other types of heart or non-heart procedures at the same time as the bypass surgery, would not be included. If for some reason doctors can't use certain grafts (like the leg vein, or both radial and right internal thoracic arteries), or if you need a specific procedure called 'coronary thrombo-endarterectomy', or if you're planning a 'hybrid' revascularization surgery, you would also be excluded.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 70 years old?
Do you need your first-ever planned heart bypass surgery?
Do you have blockages in main heart arteries, not just minor ones?
Do you have good overall health, without serious other conditions like kidney failure or certain cancers?
Have you not had a recent heart attack (within the last two days)?

Answer every question to see your result.

What does participation involve?

If you decide to participate in the ROMA study, you would be randomly assigned to one of two groups: either receiving a single arterial graft or receiving multiple arterial grafts during your heart bypass surgery. This decision is made by chance, much like flipping a coin. You wouldn't know which group you're in until after the surgery, but the medical team performing the surgery would know. Your doctors will follow your health very closely after the operation to see how you are recovering and how well the grafts are working. This will involve regular check-ups and possibly some tests. The study plans to follow patients for several years to understand the long-term benefits of each type of graft, so this is a long-term commitment. The total duration of follow-up for each participant is not specified, but typically large studies like this involve monitoring for five to ten years or more.

Potential risks and benefits

Like any medical procedure, especially surgery, there are potential benefits and risks. The potential benefit of participating is that you might receive a surgical approach (multiple arterial grafts) that *could* lead to better long-term results, such as living longer or having fewer heart-related problems. However, this is what the study aims to find out, so there's no guarantee. Regarding risks, there are general risks associated with any heart bypass surgery, such as infection, bleeding, or complications from anaesthesia. Using multiple grafts might involve a slightly longer operation or recovery time for some. You have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (59)

University of Colorado
Verified postcode
Boulder, United States· Recruiting
Baystate Health
Verified postcode
Springfield, United States· Recruiting
Nebraska Heart Hospital
Verified postcode
Lincoln, United States· Recruiting
University of Nebraska Medical Center
Verified postcode
Omaha, United States· Recruiting
NewYork-Presbyterian Brooklyn Methodist Hospital
Verified postcode
Brooklyn, United States· Recruiting
Icahn School of Medicine, Mount Sinai
Verified postcode
New York, United States· Recruiting
Weil Cornell Medical College Department of Cardiothoracic Surgery
Verified postcode
New York, United States· Recruiting
Lenox Hill Hospital (Northwell)
Verified postcode
New York, United States· Recruiting
NewYork-Presbyterian Queens
Verified postcode
New York, United States· Recruiting
Cleveland Clinic Foundation
Verified postcode
Cleveland, United States· Recruiting
Allegheny General Hospital (Cardiovascular Institute)
Verified postcode
Pittsburgh, United States· Recruiting
Innsbruck (Medical University) Austria
Verified postcode
Innsbruck, Austria· Recruiting

Common questions

What is an 'arterial graft'?

An arterial graft is a healthy blood vessel, usually taken from your chest or arm, used to bypass a blocked heart artery. They tend to last longer than vein grafts.

What is 'heart bypass surgery'?

Heart bypass surgery (CABG) is an operation to create new paths for blood to flow around blocked arteries in your heart, improving blood supply.

Will I get to choose if I have one or more grafts?

No, in this study, you will be randomly assigned to either receive one or multiple arterial grafts. This is like a lottery to ensure fair comparison.

What are the main things the study is looking for?

The study wants to see if using more arterial grafts reduces the chance of death, stroke, future heart attacks, or needing more heart procedures over time.

How long will I be involved in the study?

The study will follow your health for several years after your surgery to understand the long-term effects of the different grafting approaches.

How to find out more

Mario Gaudino, MD

mfg9004@med.cornell.edu 212.746.1812 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.