RecruitingNAINTERVENTIONAL

Trans-coronary Cooling and Dilution for Cardioprotection During Revascularisation for ST-elevation Myocardial Infarction

When someone has a heart attack, doctors use a procedure called primary PCI to open the blocked artery in the heart. While this treatment saves lives, opening the artery can sometimes cause further damage to the heart muscle. In the past, cooling the whole body was explored to protect the heart, but it had drawbacks like discomfort and delays. This new study is exploring a different approach: gently cooling the heart directly through the same thin tube used for the primary PCI procedure. This cooling uses room-temperature liquid to see if it can protect the heart muscle without the problems of whole-body cooling. This initial study will help us understand if this new method is practical and safe, and how well it helps blood flow. If successful, it could lead to bigger studies and potentially better outcomes for heart attack patients.

At a glance

Status

Recruiting

Phase

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Enrolment target

Start

01 Nov 2023

Estimated completion

01 Jan 2026

Myocardial Infarction Reperfusion Injury, Myocardial

What is this study about?

Imagine your heart is a house and one of its main water pipes suddenly gets blocked. This is similar to what happens during a heart attack (doctors call it a myocardial infarction) when an artery supplying blood to your heart muscle gets blocked. This blockage means part of your heart doesn't get enough oxygen, leading to damage.

When you go to the hospital with a heart attack, doctors quickly do a procedure called primary PCI. This involves putting a thin tube into your arm or groin, guiding it to your heart, and then using a balloon and a small mesh tube called a stent to open up the blocked artery. This is a very effective way to restore blood flow. However, sometimes when the blood flow suddenly returns, it can cause a bit more damage to the heart muscle, much like turning on a tap too quickly after a long blockage can cause a sudden rush. This extra damage is what doctors want to try and prevent.

Researchers are looking into whether gently cooling the heart directly during the primary PCI procedure can help protect it from this extra damage. Instead of cooling the whole body, which can be uncomfortable and slow down treatment, this study uses the existing tube to deliver room-temperature liquid straight to the heart. This approach has already shown some promise in a small number of patients as a safe and practical method. This current study is a pilot, meaning it’s a smaller first step. It aims to confirm that the treatment is practical for more patients and to see how well it helps restore blood flow. If this pilot study goes well, it could lead to much larger studies to see if this treatment can definitely reduce the amount of heart muscle damaged during a heart attack.

Key takeaways

This study explores a new way to protect heart muscle during a heart attack.
It uses gentle, direct heart cooling instead of whole-body cooling.
The cooling is delivered through the same tube used for standard heart attack treatment.
This is an initial, smaller study to check if the new method is safe and practical.
Participation involves special measurements during your procedure and an MRI scan.
It aims to make heart attack treatment even more effective at protecting your heart.

Who may be eligible?

This study is for people who have recently had a specific type of heart attack called an ST-elevation myocardial infarction (STEMI). To be considered, your heart attack symptoms must have started less than 12 hours before coming to the hospital. Also, when doctors look at your heart arteries, they need to see that the main artery causing the heart attack is blocked.

There are some reasons why you might not be able to join the study. For example, if you have severe asthma, are pregnant, or have other serious health problems that mean you are not expected to live longer than a year, then this study might not be suitable for you.

Quick self-check

Did your heart attack symptoms start less than 12 hours ago?
Are you pregnant?
Do you have severe asthma?
Have you been told you have a serious medical condition with less than a year to live?

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

What does participation involve?

If you are invited to join this study, your participation will begin during your usual heart attack treatment. After doctors have identified the blocked artery, you might be randomly chosen to receive the new cooling treatment, or you might receive the standard care. The cooling treatment involves gently infusing a room-temperature saline solution through the same small tube already in your heart. During the procedure, a special wire will be used to continually measure the temperature and pressure inside your artery.

A few days after your heart attack treatment, you will likely have an MRI scan of your heart to get a detailed picture of any damage. Doctors will also take blood samples at different times to look at important markers related to heart health. There are no extra hospital visits required beyond your usual care for a heart attack. The total duration of your participation in the study measurements will be during your hospital stay and the follow-up MRI scan, which typically happens a few days later.

Potential risks and benefits

Participating in this study might offer the potential benefit of reducing the amount of heart muscle damage you experience after a heart attack. However, it's important to remember that this is a new treatment being tested, and we don't yet know for sure if it will be more effective than standard care. As with any medical procedure, there are always some potential risks, though the cooling method uses room temperature liquid and the same equipment already used in standard treatment. The study is designed to be as safe as possible. You are absolutely free to withdraw from the study at any time, for any reason, and this will not affect the quality of your medical care.

Locations (1)

Harefield Hospital
Uxbridge, United Kingdom· Recruiting

Common questions

What is primary PCI?

Primary PCI is a common procedure for heart attacks. Doctors use a thin tube, balloon, and stent to open a blocked heart artery and restore blood flow.

Why do doctors want to cool the heart?

Even after opening a blocked artery, sometimes the heart muscle can still be damaged. Cooling is being investigated as a way to protect the heart from this extra damage.

Is this whole-body cooling?

No, this study is different. It's testing if gently cooling only the heart directly through a tube, using room-temperature liquid, can help, avoiding the discomfort of cooling the whole body.

What will happen if I join the study?

You'll either receive the new cooling treatment during your PCI, or standard care. Special measurements will be taken during the procedure, and you'll likely have an MRI scan and blood tests afterwards.

Will my heart attack treatment be delayed?

No, the study aims to integrate the new cooling method seamlessly into your existing treatment, without causing delays to opening your blocked artery.

How to find out more

Miles C Dalby, MD

m.dalby@rbht.nhs.uk +441895 823737 Official trial record

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