RecruitingNAINTERVENTIONAL

Comparison of the Outcomes of Single vs Multiple Arterial Grafts in Women

This study, called ROMA:Women, is looking at how different types of heart bypass surgery affect women. When someone has coronary artery disease, their heart arteries can get blocked, requiring bypass surgery. Doctors can use either a single healthy artery from elsewhere in the body (single grafting) or multiple healthy arteries (multiple grafting) to bypass these blockages. Researchers want to find out if using multiple arteries leads to better health in the long run. They will compare important health events like future heart attacks, strokes, and hospital stays, as well as how happy and healthy women feel in their daily lives. The study aims to recruit 2,300 women to understand which approach offers the best outcomes.

At a glance

Status

Recruiting

Phase

Sponsor

Weill Medical College of Cornell University

Enrolment target

2,300

Start

17 Apr 2023

Estimated completion

01 Mar 2030

Heart Diseases Coronary Artery Disease Coronary Artery Bypass Grafting

What is this study about?

Heart bypass surgery, known as Coronary Artery Bypass Grafting (CABG), is a common operation for people with blocked arteries around their heart. During this surgery, doctors take healthy blood vessels, often from your arm or leg, and attach them to your heart to create new pathways around the blocked areas. This helps blood flow more freely to your heart muscle.

There are two main ways doctors can perform this type of bypass: using just one new healthy artery, or using several new healthy arteries. This study, called ROMA:Women, specifically focuses on women undergoing this surgery. The main idea behind this research is to see if using multiple healthy arteries for the bypass leads to better health results over time compared to using just one. Researchers think that multiple grafts might offer a more lasting solution and improve how women feel after surgery.

To find this out, the study will compare women who receive a single arterial graft with those who receive multiple arterial grafts. They will look at important things like whether women have fewer serious heart-related problems in the future (such as heart attacks or strokes), need fewer repeat procedures, or have to go back to hospital. The study will also carefully check how the surgery affects a woman's quality of life – meaning how well they can do daily activities and how they feel emotionally and physically. They'll also consider if these benefits are consistent across different groups of women, like those of different ages or with conditions like diabetes.

Key takeaways

This study compares two types of heart bypass surgery for women: using one or using multiple clean arteries.
The main goal is to see if using multiple arteries leads to better long-term health and a higher quality of life.
Researchers will track important health events like future heart attacks, strokes, and hospital stays.
They will also measure how surgery impacts physical and mental well-being.
Participants will be women aged 18 and over needing their first heart bypass surgery.
Each participant will be randomly assigned to one of the two surgery types.

Who may be eligible?

This study is looking for women aged 18 and over who need their first heart bypass surgery. You would be considered if you have significant blockages in the main arteries of your heart that require this type of operation.

However, there are certain situations where you wouldn't be able to join. For example, if you're a man, or if this isn't your very first heart surgery, you wouldn't be eligible. Also, if your heart attack happened very recently (within 3 days of needing surgery) or if your heart function is very weak, you might not be able to participate.

Other reasons you might not be able to join include needing another heart operation at the same time as the bypass, having a serious illness that significantly shortens your life expectancy, or if doctors expect you to need a special procedure called coronary thrombo-endarterectomy, or a planned 'hybrid' surgery approach.

Quick self-check

Are you a woman aged 18 or older?
Do you need your first heart bypass surgery?
Do you have significant blockages in your heart arteries?
Have you had a heart attack more than 3 days ago if applicable?
Do you have good general health without other severe conditions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll be randomly assigned to receive either a single or multiple arterial grafts during your heart bypass surgery, much like flipping a coin. You won't get to choose which type of surgery you receive. After your surgery, the research team will regularly check on your health and well-being. This will involve appointments and filling out questionnaires to understand your quality of life, how you're feeling, and if you've experienced any heart-related events like heart attacks or strokes.

These check-ups will continue over several years to understand the long-term effects of the surgery. The study involves your medical team collecting information about your health through your regular hospital visits and possibly asking you to complete specific surveys about your physical and mental health. The exact frequency and duration of follow-up will be explained in detail by the research team if you decide to participate.

Potential risks and benefits

Taking part in this study means you could potentially benefit from receiving a type of heart bypass surgery that might lead to better long-term health outcomes and an improved quality of life, although this is what the study aims to find out. Like any surgery, heart bypass carries risks, including bleeding, infection, and other complications, regardless of whether a single or multiple graft is used. There's also the risk that the type of surgery you receive might not be as effective for you as the other option. You are free to withdraw from the study at any time without giving a reason, and this will not affect the quality of medical care you receive.

Locations (146)

Cedars-Sinai Medical Center
Los Angeles, United States· Recruiting
Pomona Valley Hospital Medical Center
Pomona, United States· Recruiting
University of California, San Francisco
San Francisco, United States· Recruiting
University of Colorado
Aurora, United States· Recruiting
Hartford Hospital
Hartford, United States· Recruiting
Yale University Hospital
New Haven, United States· Recruiting
Emory University
Atlanta, United States· Recruiting
University of Chicago
Chicago, United States· Recruiting
Indiana University
Indianapolis, United States· Recruiting
University of Iowa
Iowa City, United States· Recruiting
Johns Hopkins University
Baltimore, United States· Recruiting
Baystate Health
Springfield, United States· Recruiting

+134 more sites — see the official record for the full list.

Common questions

What is heart bypass surgery?

It's an operation to improve blood flow to your heart by using healthy blood vessels from other parts of your body to bypass blocked arteries.

What does 'single' or 'multiple' arterial grafts mean?

It refers to whether your surgeon uses one healthy artery or several healthy arteries to create new paths for blood flow to your heart.

Why is this study only for women?

This specific study wants to understand the effects of these surgeries particularly in women, as health outcomes can sometimes differ between men and women.

Will I get to choose which type of bypass I have?

No, if you join the study, you'll be randomly assigned to receive either a single or multiple arterial graft, like drawing lots.

What is 'quality of life' in this study?

It means how your surgery affects your overall well-being, including your physical and mental health, and your ability to do daily activities.

How to find out more

Mario Gaudino, Prof/PhD/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.