RecruitingNAINTERVENTIONAL

A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)

This study, called "The Optimal Trial," is looking at the best way to treat heart arteries that have become hardened and narrow due to a build-up of calcium. Doctors are comparing two different approaches to plan a procedure called PCI, which opens up blocked arteries. One approach uses detailed CT scans (called CCTA) to help doctors understand the calcium better before the procedure. The other approach uses a small internal ultrasound (called IVUS), which is a common method now. The main goal is to see if using the CT scan information can make the procedure more efficient and improve how the stent sits in the artery, without compromising patient safety or long-term heart health compared to the current standard of care.

At a glance

Status

Recruiting

Phase

Sponsor

Fundación EPIC

Enrolment target

700

Start

22 Dec 2025

Estimated completion

01 Jan 2030

Cardiovascular Diseases Myocardial Ischemia Heart Diseases Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Coronary Artery Disease

What is this study about?

This study is about finding the best way to treat a common heart problem called Coronary Artery Disease. This happens when the blood vessels supplying your heart get hardened and narrowed, often due to calcium build-up. This can lead to chest pain (angina) and, in some cases, a heart attack. If you have this condition, doctors might recommend a procedure called Percutaneous Coronary Intervention (PCI) to open up the blocked artery, often by putting in a small tube called a stent.

The "Optimal Trial" is looking at two different strategies doctors use to prepare for and perform this PCI procedure, especially when there's a lot of calcium in the artery. One strategy uses very detailed CT scans (Coronary CT Angiography, or CCTA) to get a clear picture of the calcium before the procedure. This helps doctors plan the best way to tackle the hardened artery. The other strategy, which is currently a standard approach, uses a tiny ultrasound device (Intravascular Ultrasound, or IVUS) inserted inside the artery during the procedure to guide them.

The main aim of this study is to see if using the advanced CT scan information beforehand can make the PCI procedure more effective and efficient for doctors, helping them get a better result with the stent. Importantly, they also want to make sure that this new CT-guided approach is just as safe and has similar good outcomes for patients in the long run as the current IVUS-guided method. It's about finding out if this detailed, non-invasive imaging can lead to better treatment.

Key takeaways

This study compares two ways to plan heart artery procedures.
It aims to find the best method for treating hardened arteries.
One method uses advanced CT scans, the other uses internal ultrasound.
The study wants to see if CT scans improve procedure efficiency and safety.
Participation involves a heart procedure and about a year of follow-up.

Who may be eligible?

To join this study, you would need to be an adult between 18 and 85 years old. You should have a clear diagnosis of heart problems like chest pain (angina) or silent ischemia (where your heart isn't getting enough blood but you don't feel pain), which your doctor believes can be helped by a procedure to open up your arteries (PCI). Your arteries also need to be a certain size, and you must agree to take part by signing a consent form.

There are also some reasons why you wouldn't be able to join. For example, if you've recently had a very serious type of heart attack (STEMI), have severe and uncontrolled irregular heartbeats, or if your blood pressure is very unstable. Other reasons include being on kidney dialysis, having a very narrow main heart artery, or if you've already had a stent in the artery being studied. You also might not be eligible if you have certain other serious health conditions or are undergoing extensive surgery soon after the heart procedure.

Quick self-check

Are you between 18 and 85 years old?
Do you have a heart condition needing a procedure to open blocked arteries?
Do you *not* have a very serious recent heart attack (STEMI) or actively unstable heart rhythm?
Have you *not* had a stent in the specific artery being studied before?
Are you able to agree and sign a consent form to participate?

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

What does participation involve?

If you join the study, you'll be randomly assigned to one of two groups. One group will have their heart procedure planned using advanced CT scans, and the other will have it planned using internal ultrasound, which is the usual way. You will undergo the PCI procedure as planned. Doctors will also inspect how the stent sits using the internal ultrasound. After your procedure, you'll have follow-up visits or checks for about 12 months to make sure everything is going well. The total duration of your active participation, including these follow-up checks, is expected to be about a year.

Potential risks and benefits

Taking part in this study might offer the benefit of receiving a heart procedure guided by potentially more advanced planning. There's also the chance to help doctors learn more about the best ways to treat hardened arteries, which could benefit many patients in the future. However, as with any medical procedure, there are potential risks associated with PCI and imaging, including the standard risks of the procedure itself, and potentially rare complications from the imaging techniques used. You will be fully informed of these before deciding to participate. Remember, you can withdraw from the study at any time without affecting your medical care.

Locations (13)

Bringham and Women's Hospital
Boston, United States· Not yet recruiting
Minneapolis Heart Institute
Minneapolis, United States· Not yet recruiting
HACKENSACK MERIDIAN HEALTH, Inc
Jersey City, United States· Not yet recruiting
Columbia University Irving Medical Center/NewYork-Presbyterian Hospital
New York, United States· Not yet recruiting
Weill Medical College of Cornell University
New York, United States· Not yet recruiting
Hospital Universitari Vall Hebron
Barcelona, Spain· Recruiting
Hospital Universitario de Leon
León, Spain· Recruiting
Hospital Universitario La Paz
Madrid, Spain· Recruiting
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom· Not yet recruiting
St Bartholomew's Hospital (Barts Health NHS Trust)
London, United Kingdom· Not yet recruiting
St George's University Hospitals NHS Foundations Trust
London, United Kingdom· Not yet recruiting
Newcastle Hospitals NHS Foundations Trust
Newcastle, United Kingdom· Not yet recruiting

+1 more sites — see the official record for the full list.

Common questions

What is Coronary Artery Disease?

It's a condition where the blood vessels that supply your heart become narrowed and hardened, often due to a build-up of fatty deposits and calcium, making it harder for blood to reach your heart.

What is a PCI procedure?

PCI stands for Percutaneous Coronary Intervention. It's a keyhole procedure where a doctor inserts a tiny balloon to open up a blocked heart artery, often followed by placing a small mesh tube called a stent to keep it open.

What's the difference between CT scans and IVUS?

A CT scan (CCTA) is an external scan that takes detailed pictures of your heart arteries before the procedure. IVUS (Intravascular Ultrasound) is a tiny ultrasound device that doctors use inside your artery during the procedure to see what's happening up close.

Will I know which treatment group I'm in?

Because it's a 'randomized' study, you won't choose your group; it will be decided by chance, like flipping a coin. You and your doctors may know which approach is being used for your care.

How long will I be involved in the study?

Your involvement, including follow-up checks after your procedure, will last for about 12 months.

How to find out more

CAROLINA FOCELLA

cfocella@crf.org 001 917 753 6695 Official trial record

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