RecruitingNAINTERVENTIONAL

Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease

This UK study, called COMPLETE-2, is looking at the best way to treat people who have had a heart attack and also have other narrowed arteries. After the main blockage causing the heart attack is fixed, doctors often treat these other narrowed arteries as well. This trial compares two approaches: one uses special small wires to measure blood flow and guide treatment, while the other relies on standard X-ray pictures of the arteries. The aim is to see if one method is safer or more effective in preventing future heart problems like another heart attack, or even death. Participants will be followed up over several years.

At a glance

Status

Recruiting

Phase

Sponsor

Population Health Research Institute

Enrolment target

5,100

Start

22 Jun 2023

Estimated completion

01 Jun 2028

Acute Myocardial Infarction Coronary Artery Disease

What is this study about?

When someone has a heart attack, it's usually because one of the main arteries supplying blood to their heart becomes blocked. Doctors perform a procedure called PCI (Percutaneous Coronary Intervention) to open up this blockage quickly. However, many people who have a heart attack also have other narrowed arteries in their heart that weren't the cause of the heart attack itself. Doctors often decide to treat these other narrowed arteries too, to try and prevent future problems.

This study, called COMPLETE-2, aims to find the best way to treat these extra narrowed arteries. It's comparing two common methods. One method, called 'physiology-guided', uses special wires placed inside the arteries. These wires can measure blood pressure and flow, helping doctors decide if a narrowing is significant enough to cause problems and needs to be treated. The other method, 'angiography-guided', relies on standard X-ray pictures (angiograms) to visually assess the narrowings.

The main goal is to see if one of these approaches leads to better long-term results for patients. This includes looking at things like whether it reduces the chance of another heart attack, needing more heart procedures, or sadly, death from heart-related causes. The study also looks at safety, comparing the risk of complications such as serious bleeding or problems with the heart stent when using each method.

Key takeaways

The study compares two common methods for treating extra narrowed arteries after a heart attack.
It aims to find out which method is safer and more effective in preventing future heart problems.
Participation involves ongoing follow-up for five years.
You would receive either physiology-guided or angiography-guided treatment for non-culprit lesions.
This research helps improve care for people who have had a heart attack and have other blocked arteries.

Who may be eligible?

This study is looking for adults who have recently had a heart attack (either a STEMI or a NSTEMI type) and successfully had the main blockage fixed. You would also need to have other narrowed heart arteries that doctors believe could be treated with a procedure called PCI.

There are certain reasons why you wouldn't be able to join. For example, if you've already had a major heart bypass surgery, or if the doctors can't clearly identify which artery caused your heart attack. Also, if your heart attack was thought to be due to something other than the usual narrowing of arteries, like a tear in the artery wall.

Crucially, you wouldn't be eligible if you're expected to live for less than two years due to other health issues, or if there are other practical reasons that would make it difficult for you to take part in a long-term study.

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.

Have you recently had a heart attack (STEMI or NSTEMI)?
Has the main blockage from your heart attack already been successfully treated?
Do your doctors believe you have other narrowed heart arteries that can be treated?
Are you able to attend follow-up appointments for approximately five years?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of the two treatment groups: either having your extra narrowed arteries treated with guidance from special blood flow measurements, or with guidance from standard X-ray pictures. Both are established medical procedures.

You would have regular follow-up appointments, which may involve health checks and possibly further tests, over a period of five years. The medical team will keep a close eye on your health and any heart-related events during this time. You won't start any new medication specifically for the study, but your existing heart medications will be carefully managed as usual by your doctors.

Potential risks and benefits

Taking part in a study like this helps improve our understanding of heart attack treatment, potentially benefiting many future patients. However, there are potential risks associated with any medical procedure, including the heart procedures involved in this study, such as bleeding, infection, or issues with the heart stent. There's also the chance that the treatment method you receive might not be the most effective for you individually. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (113)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

UCLA
Verified postcode
Los Angeles, United States· Recruiting
University of California, San Francisco
Verified postcode
San Francisco, United States· Recruiting
Cardiovascular Research Institute of Kansas
Verified postcode
Wichita, United States· Recruiting
The Johns Hopkins University School of Medicine
Verified postcode
Baltimore, United States· Recruiting
University of Michigan
Verified postcode
Ann Arbor, United States· Recruiting
Metropolitan Cardiology Consultants / Metropolitan Heart and Vascular Institute (MCC/MHVI)
Verified postcode
Coon Rapids, United States· Recruiting
RWJ Barnabas Health
Verified postcode
Jersey City, United States· Recruiting
Bassett Medical Center
Verified postcode
Cooperstown, United States· Recruiting
VA New York Harbor HealthCare System
Verified postcode
New York, United States· Recruiting
NYU Grossman School of Medicine
Verified postcode
New York, United States· Recruiting
Montefiore Medical Center
Verified postcode
The Bronx, United States· Recruiting
Cleveland Clinic
Verified postcode
Cleveland, United States· Recruiting

Common questions

What is a heart attack (MI)?

A heart attack happens when blood flow to a part of the heart is blocked, often by a clot, causing damage to the heart muscle. STEMI and NSTEMI are two types of heart attacks.

What is PCI?

PCI (Percutaneous Coronary Intervention) is a procedure to open narrowed or blocked heart arteries, usually by inserting a small balloon and sometimes a stent (a tiny mesh tube) to keep the artery open.

What does 'multi-vessel disease' mean?

It means you have narrowing or blockages in more than one of the main arteries that supply blood to your heart.

What's the difference between physiology-guided and angiography-guided treatment?

Physiology-guided treatment uses special wires to measure blood flow and pressure to precisely decide which narrowings need treatment. Angiography-guided relies on visual assessment from X-ray pictures.

How long will I be involved in the study?

If you participate, you will be followed up by the study team for five years after your treatment.

How to find out more

COMPLETE-2 Project Office

complete-2@phri.ca (905) 521-2100 Official trial record

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