Not yet recruitingNAINTERVENTIONAL

Digital MEDIcal TWIN for the Prediction of Arrhythmic Sudden Cardiac Death After a Myocardial Infarction

This research study, called TWIN-SCD STEMI, is looking for better ways to figure out which patients are at high risk of sudden cardiac arrest after a heart attack. Currently, doctors use a measurement called Left Ventricular Ejection Fraction (LVEF) to decide if someone needs a special device called a defibrillator. However, this method isn't always accurate. Many people who get the device don't actually need it, and some who do need it aren't identified. This study hopes to create a new, more accurate prediction tool by looking at various health information, including scans and other tests, from people who have recently had a heart attack. The goal is to help doctors make more informed decisions about preventing sudden cardiac arrest.

At a glance

Status

Not yet recruiting

Phase

Sponsor

University Hospital, Bordeaux

Enrolment target

1,000

Start

15 Apr 2026

Estimated completion

31 Dec 2034

Sudden Cardiac Death Myocardial Infarction

What is this study about?

When someone has a heart attack, it can sometimes lead to a very serious problem called sudden cardiac arrest. This happens when the heart's electrical system goes haywire and stops pumping blood effectively. In some cases, a special device called a defibrillator can be implanted to reset the heart if this happens. Doctors currently decide who needs this device based on a measurement of how well the heart pumps, called the Left Ventricular Ejection Fraction (LVEF).

However, this current method isn't perfect. For example, many people who receive a defibrillator never actually need it, and having the device comes with its own potential risks. On the other hand, many cases of sudden cardiac arrest happen in people whose LVEF looks normal enough that they wouldn't be offered a defibrillator based on current guidelines. This means we're either giving devices to people who might not need them, or missing people who could benefit.

This study is trying to develop a better way to predict who is truly at risk of sudden cardiac arrest after their first heart attack. Researchers will look at many different pieces of information, including your medical history, blood tests, detailed heart scans like CT and MRI, and electrical recordings of your heart. By putting all this information together, they hope to create a more accurate prediction tool. Ultimately, this could help doctors make more precise decisions about who needs a defibrillator, potentially saving lives and avoiding unnecessary procedures for others.

Key takeaways

New research aims to improve predictions for sudden cardiac arrest after a heart attack.
Current methods for identifying at-risk patients aren't perfect.
The study will use various tests, including scans and electrical recordings.
Goal is to create a more accurate prediction tool for future patient care.
Your participation could help save lives in the future.

Who may be eligible?

To be considered for this study, you must have experienced a specific type of heart attack called an ST-segment elevation myocardial infarction (STEMI) within the last six months. You also need to be able to understand the study and agree to participate by signing a consent form, and be covered by health insurance.

There are also some reasons why you wouldn't be able to join. These include having very poor kidney function or another serious illness that doctors believe would shorten your life to less than a year. If you are pregnant, breastfeeding, or planning to become pregnant within two years, you cannot participate. Also, if you are unable to understand what the study involves or are under legal protection, you would not be eligible.

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 I had a STEMI heart attack in the last 6 months?
Am I able to understand and sign a consent form?
Do I have health insurance coverage?
Am I pregnant or planning to be pregnant soon?
Do I have severe kidney problems or other serious illnesses?
Am I under legal protection?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the researchers will collect various pieces of information about you. This will include details from your medical history, blood tests, and advanced imaging scans of your heart, such as a Cardiac CT scan and MRI scans to look at any scarring. You will also have electrical recordings of your heart using a 12-lead ECG and a 24-hour Holter ECG, which records your heart rhythm over a day. A procedure called programmed ventricular stimulation might also be performed. This study aims to gather this information to build a new prediction model, and researchers will follow your health for one or two years to see if the new model is accurate in predicting potential heart rhythm problems.

Potential risks and benefits

Taking part in this study may offer the potential benefit of helping researchers develop better ways to prevent life-threatening heart problems for future patients, although there's no direct guarantee of personal benefit to you. Potential risks are associated with the tests involved, such as radiation exposure from CT scans, and the slight risks involved with any medical procedure. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

CHU de Bordeaux, Hôpital Cardiologique du Haut-Lévêque
Verified postcode
Pessac, France

Common questions

What is sudden cardiac arrest?

Sudden cardiac arrest is when your heart suddenly stops beating effectively due to an electrical problem, which can be life-threatening.

What is a defibrillator?

A defibrillator is a small device implanted in your chest that can deliver an electric shock to restart your heart if it goes into a dangerous rhythm.

What is an LVEF measurement?

LVEF stands for Left Ventricular Ejection Fraction. It's a measurement that tells doctors how well the main pumping chamber of your heart is working.

Will I get a defibrillator if I join this study?

This study is about predicting who might need a defibrillator in the future. The decision to get a defibrillator will still be made by your doctor, based on current medical guidelines and your individual health.

What is a heart attack?

A heart attack occurs when blood flow to a part of your heart is blocked, usually by a blood clot, causing damage to the heart muscle.

How to find out more

Edouard GERBAUD, MD

edouard.gerbaud@chu-bordeaux.fr +33(0)524549188 Official trial record

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