Active not recruitingNAINTERVENTIONAL

Impact of Preoperative FFR on Arterial Bypass Graft Functionality

This study is investigating how a measurement called Fractional Flow Reserve (FFR), taken before heart bypass surgery, might predict the success of arterial grafts. Heart bypass surgery, known as CABG, helps improve blood flow to the heart. Doctors want to understand if knowing the FFR measurement beforehand can tell them how well these new arteries will work six months after the operation. Patients with multiple blocked or narrowed heart arteries will have an FFR test, then undergo bypass surgery using arterial grafts. Six months later, they will have another test to see how well the grafts are working. This could help doctors make better decisions about treatment.

At a glance

Status

Active not recruiting

Phase

Sponsor

Ottawa Heart Institute Research Corporation

Enrolment target

120

Start

01 Nov 2015

Estimated completion

01 Nov 2028

Heart Disease

What is this study about?

This study is designed to help doctors understand more about heart bypass surgery, specifically focusing on the new blood vessels, called grafts, that are used. When someone has blocked heart arteries, bypass surgery creates new pathways for blood to flow around the blockages, restoring healthy blood supply to the heart muscle.

Before bypass surgery, doctors can perform a test called Fractional Flow Reserve (FFR). This test helps measure how well blood is flowing through the heart arteries. Researchers want to find out if this FFR measurement, taken before surgery, can predict how successfully these new grafts will work six months after the operation. They are particularly interested in arterial grafts, which are often preferred for their long-term benefits.

By understanding this connection, doctors hope to get a clearer picture of how to best help patients with heart disease. The aim is to improve the long-term success of bypass surgery and ensure patients get the most effective treatment possible. This research could help doctors make more informed decisions about planning your heart surgery.

Key takeaways

This study aims to understand how successful arterial bypass grafts are in heart surgery.
It uses a test called FFR before surgery to see if it can predict graft success.
Participants will have heart bypass surgery using arterial grafts.
A follow-up test six months later will check graft function.
The research could help doctors improve future heart bypass treatments.

Who may be eligible?

This study is looking for adults aged 18 or older who have multiple blocked or narrowed heart arteries and are scheduled for their first heart bypass surgery (CABG). You must be having arterial grafts as part of your surgery, whether it's performed with or without a heart-lung machine.

However, there are reasons why you might not be able to take part. For example, if you've already had bypass surgery or a procedure called a PCI in the last six months, or if you need other major surgery (like a valve repair) at the same time as your bypass, you won't be eligible. Also, if you have severe kidney problems, a history of significant bleeding, or severe heart failure, this study might not be suitable for you.

Women who are pregnant or trying to get pregnant cannot participate. Other conditions, like certain blood disorders, being in another clinical trial, or having a serious illness that limits your life expectancy, would also prevent you from joining. The research team will discuss all these points with you to see if the study is a good fit.

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 18 years old or older?
Are you scheduled for your first heart bypass surgery (CABG) for multiple blocked arteries?
Will your surgeon be using arterial grafts during your bypass surgery?
Have you not had a heart procedure like PCI or another bypass in the last 6 months?
Are you able to attend follow-up appointments, including a health check and angiogram, 6 months after surgery?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have specific tests during your diagnostic workup before your bypass surgery. This includes a heart angiogram and an FFR measurement. You will then proceed with your planned heart bypass surgery, where arterial grafts will be used. Six months after your surgery, you will have another angiogram to check how well your new grafts are working. The total study duration for each participant is approximately six months, covering the period from your initial tests to your follow-up angiogram.

Potential risks and benefits

Taking part in this study involves having an FFR test before your surgery and a follow-up angiogram six months afterwards. While these are common medical procedures, all medical procedures carry some small risks, such as bleeding, infection, or discomfort. You will be closely monitored by medical professionals. The potential benefit is that your participation could contribute to a better understanding of heart bypass surgery, which may help future patients. You have the right to withdraw from the study at any time without affecting your medical care.

Locations (2)

Clinique Saint-Luc Bouge
Verified postcode
Bouge, Belgium
University of Ottawa Heart Institute
Verified postcode
Ottawa, Canada

Common questions

What is FFR?

FFR stands for Fractional Flow Reserve. It's a test doctors use to measure blood flow in your heart arteries and see if blockages are stopping enough blood from getting to your heart.

What is a 'bypass graft'?

A bypass graft is a new blood vessel, taken from another part of your body (like your leg or arm), that surgeons use to create a new path for blood to flow around a blocked heart artery.

Why use 'arterial grafts'?

Arterial grafts are often used in bypass surgery because they tend to last longer than grafts made from veins, helping blood flow well for many years.

Will this study change my surgery?

No, your bypass surgery will proceed as planned by your medical team. This study is observing the results of standard care combined with an FFR test.

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