RecruitingOBSERVATIONAL

Risk Characterization of Non-culprit Vessels in Patients Undergoing Primary PCI for ST-elevation MI in Multivessel Disease

This study is for people who've had a specific type of heart attack (STEMI) and have blockages in more than one heart artery. When you have a STEMI, doctors quickly open the most urgent blocked artery. But it's less clear what to do about other narrowed arteries. Some doctors open all of them, but this adds risks. This study wants to find a way to identify which other narrowings are truly dangerous and need to be opened with balloons and stents, and which can be safely treated with medicines. Researchers will use special scans to help make these important decisions.

At a glance

Status

Recruiting

Sponsor

University Hospital Southampton NHS Foundation Trust

Enrolment target

320

Start

20 Jan 2025

Estimated completion

01 Jan 2029

ST Elevation Myocardial Infarction

What is this study about?

Imagine your heart is a house and the arteries are pipes bringing water. A heart attack is like a main pipe suddenly getting completely blocked. Doctors act fast to unblock it and save your house. However, sometimes there are other pipes in your house that are also a bit narrowed. What should the plumbers do about those? Should they fix all of them right away, or only the ones that look like they might cause problems in the future?

Currently, if you have a certain type of heart attack (called a STEMI), doctors quickly open the main blocked artery using a procedure where they put a balloon and a small tube called a stent into your artery. This saves lives and limits damage. But about half of these patients also have other arteries that are narrowed. Some studies have suggested it might be better to fix all these other narrowed arteries at the same time, but this means a more complicated procedure and not all narrowed arteries are equally risky.

This study, called PICNIC, wants to find a smarter way. We want to identify which of those other narrowed arteries are most likely to cause problems later on, like another heart attack or chest pain (angina). By using special imaging from CT scans and looking at things like inflammation, we hope to learn which narrowings are dangerous and only treat those. If successful, this could help doctors make better decisions for each patient, avoiding unnecessary procedures while still protecting your heart.

Key takeaways

This study aims to improve treatment for heart attack patients with multiple narrowed heart arteries.
It's trying to find out which 'other' narrowed arteries are high-risk and need treatment, versus those that don't.
Researchers will use special CT scans and blood tests to identify these high-risk narrowings.
The goal is to help doctors make more personalised decisions for future patients, reducing unnecessary procedures.
Taking part helps advance medical knowledge but does not guarantee direct individual benefit.

Who may be eligible?

This study is looking for adults aged 18 to 85 who have recently had a specific type of heart attack called a STEMI. You must have had the main blocked artery opened by a balloon and stent procedure. You also need to have other arteries that are narrowed by more than 50% but not completely blocked, and these arteries must be big enough (at least 2.5mm).

There are also some reasons why you wouldn't be able to join. For example, if you're very unwell after your heart attack (like being in shock or needing a breathing machine), if you've had previous heart bypass surgery, or if you have certain other serious health problems like active cancer. We also can't include you if you're allergic to the dye used in CT scans, or if you're pregnant.

Importantly, if doctors have already decided to open up those other narrowed arteries before you could join the study, then you wouldn't be able to take part. Also, if the main artery in your heart (left main stem) is very narrowed, or if there's a clot in the other narrowed arteries, you wouldn't be suitable.

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 aged between 18 and 85?
Have you recently had a specific type of heart attack called a STEMI?
Did you have your main blocked artery opened with a balloon and stent (primary angioplasty)?
Do you have other narrowed heart arteries (not completely blocked)?
Are you generally well and not suffering from other serious illnesses like active cancer or severe kidney problems?
Are you not pregnant or allergic to CT scan dye?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will need to give your written consent after your heart attack treatment. The study team will then assess your eligibility. Taking part involves having a special heart CT scan after your main blocked artery has been treated. This scan will help doctors look closely at the other narrowed arteries. We will also take some blood samples to check for signs of inflammation. The study involves keeping track of your health over time, but it doesn't involve extra visits beyond your usual follow-up appointments with your heart doctor. The information gathered will be used to understand which narrowings become problematic in the future. The total duration of your involvement will depend on how long we follow up to see how your other narrowings behave.

Potential risks and benefits

The potential benefits of this study include helping to improve our understanding of heart conditions, which could lead to better and more targeted treatments for future patients like yourself. There's also the possibility that the study findings could directly inform your subsequent care, although this is not guaranteed for individual participants. Potential risks primarily relate to the CT scan, such as exposure to a small amount of radiation, and a very small risk of allergic reaction to the dye. Blood tests carry a minor risk of bruising. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your medical care.

Locations (3)

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

University Hospitals Dorset NHS Foundation Trust
Verified postcode
Bournemouth, United Kingdom· Recruiting
University Hospital Southampton NHS Foundation Trust
Verified postcode
Southampton, United Kingdom· Recruiting
Royal Stoke University Hospital
Verified postcode
Stoke-on-Trent, United Kingdom· Recruiting

Common questions

What is a STEMI heart attack?

A STEMI is a very serious type of heart attack where one of your heart's main arteries is completely blocked, stopping blood flow to a large part of your heart muscle. It needs immediate treatment.

What does 'primary angioplasty' mean?

This is an emergency procedure to open up the blocked heart artery during a STEMI. Doctors use a tiny balloon to push the blockage aside and then often place a small mesh tube called a stent to keep the artery open.

Why is it important to study other narrowed arteries?

While doctors fix the main blockage right away, many heart attack patients have other narrowed arteries. We want to find out which of these other narrowings are truly dangerous and could cause problems later, and which ones are less risky, so we can give you the best treatment.

Will I get extra treatment in this study?

The study's main goal is to understand which narrowed arteries are risky. It uses tests like special CT scans to gather information. It won't directly give you extra treatment beyond what your doctors normally recommend for your condition.

How long will I be involved in the study?

After your initial assessments, your involvement will mostly be about us collecting information from your routine follow-up care. The total time you're 'in the study' depends on how long researchers watch to see how your heart is doing.

How to find out more

Zoe Nicholas

zoe.nicholas@uhs.nhs.uk 02381208538 Official trial record

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