Not yet recruitingNAINTERVENTIONAL

Evaluation of the Effectiveness of an Interdisciplinary Intervention After Acute Coronary Syndrome on Low-Density Lipoprotein Cholesterol Levels

This study, taking place in France, aims to improve care for people who have recently had a serious heart event, like a heart attack. After such an event, it's very important to lower 'bad' cholesterol (LDL) to prevent future problems. However, many people struggle to reach these target levels. Researchers are comparing two approaches: the usual care patients receive, and a new 'intervention' plan. The new plan adds extra support from a team of healthcare professionals, including specialist nurses, dietitians, and pharmacists, shortly after leaving the hospital. The main goal is to see if this extra support helps more patients achieve healthy LDL cholesterol levels 12 months after their heart event. The study involves 230 adult patients.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Assistance Publique - Hôpitaux de Paris

Enrolment target

230

Start

01 Nov 2025

Estimated completion

01 Nov 2028

Acute Coronary Syndromes (ACS)Acute Coronary Syndromes

What is this study about?

When someone has a serious heart problem, like a heart attack (also known as Acute Coronary Syndrome or ACS), it's a very serious event. Sadly, heart diseases are a leading cause of death worldwide. After a heart attack, it's really important to make changes and take medicines to prevent future problems. A key part of this is getting your 'bad' cholesterol, called LDL cholesterol, down to a healthy level. Doctors recommend a specific target for LDL cholesterol and want to see a big drop from what it was before.

However, it's been noticed that many people find it hard to reach these important cholesterol targets. This could be for various reasons, like getting older, having other health conditions, or not having easy access to all the care they need. For example, in France, not everyone gets to join heart rehabilitation programmes, which are very helpful. Because of these challenges, researchers believe we need to find better ways to support people after a heart attack to help them manage their health.

This study wants to test a new idea. Researchers think that if patients get extra support from a team of different healthcare professionals – like specialist nurses, dietitians, and pharmacists – in addition to their usual care, they might have a better chance of reaching their healthy LDL cholesterol goals. This extra support could include special appointments soon after leaving the hospital. The study will follow people for 12 months to see if this new approach truly makes a difference in their cholesterol levels.

Key takeaways

This study aims to improve care for people after a heart attack.
It compares usual care with a new plan providing extra healthcare support.
The main goal is to help more patients achieve healthy 'bad' cholesterol levels.
The study involves 230 adult patients in France.
Extra support includes specialist nurses, dietitians, and pharmacists.
Participation lasts for 12 months and includes follow-up appointments.

Who may be eligible?

To be part of this study, you need to be an adult who has recently been in hospital for a heart problem like a heart attack (Acute Coronary Syndrome). You also need to understand what the study involves and agree to take part by signing a consent form. It's important that you are covered by a social security scheme.

However, there are reasons why you might not be able to join. For example, if your heart attack caused certain serious complications, or if you have severe issues with thinking or mental health problems that aren't well-controlled. You also can't join if you have ongoing infections or inflammatory conditions, or if physical activity is not possible for you due to an orthopaedic problem.

Also, if you are currently pregnant or breastfeeding, or already taking part in another study looking at lowering cholesterol, you won't be able to join this one. Finally, if you receive state medical assistance or have a legal guardian, 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.

Are you an adult (18 years or older)?
Have you recently been in hospital for a heart attack or similar heart problem?
Can you understand and agree to the study details?
Do you *not* have certain serious heart complications from your recent illness?
Are you *not* pregnant or breastfeeding?
Are you *not* currently taking part in another study to lower cholesterol?

Answer every question to see your result.

What does participation involve?

If you join this study, your care will depend on which group you are in. Some participants will receive 'routine care,' which means your hospital will arrange your follow-up, such as heart rehabilitation and appointments with your GP or heart specialist, as they normally would. Other participants will receive the 'intervention' care. This means you will get your routine care, but you will also have an extra consultation with a team of healthcare professionals about one month after leaving the hospital. Following this, you will have three more consultations with a specially trained nurse (called an Advanced Practice Nurse or IPA) at 3, 6, and 12 months after discharge. The study will track your LDL cholesterol levels over this 12-month period to see if the extra support makes a difference.

Potential risks and benefits

Taking part in any study has potential benefits and risks. For any participant, a possible benefit is more structured follow-up, which could help manage your heart health better. Specifically, those in the 'intervention' group will receive extra support from a healthcare team, which might help them achieve healthier cholesterol levels and potentially reduce future heart problems. There aren't many extra risks beyond what you'd experience with standard medical care, as this study focuses on how care is delivered rather than introducing new medications or procedures. You will also have blood tests for cholesterol, which are routine after a heart problem. Remember, you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (4)

Centre Hospitalier Sud Francilien, Pôle Cardiologie
Verified postcode
Corbeil-Essonnes, France
Hopital Saint Joseph-Saint Luc, Cardiologie
Verified postcode
Lyon, France
CHU Montpellier - Hôpital Arnaud de Villeneuve, Cardiologie
Verified postcode
Montpellier, France
Hôpital Européen Georges Pompidou - AP-HP, Cardiologie
Verified postcode
Paris, France

Common questions

What is 'LDL cholesterol' and why is it important?

'LDL cholesterol' is often called 'bad' cholesterol. High levels can lead to blockages in your arteries, increasing your risk of heart problems. Keeping it low after a heart attack is crucial for your health.

What is an 'Acute Coronary Syndrome' (ACS)?

ACS is a term for serious heart problems, including heart attacks. It means that there's a sudden reduction or blockage of blood flow to the heart.

Will I know which 'care pathway' I'm on?

Yes, you will be told if you are in the 'routine care' group or the 'intervention' group after you join the study. This decision is made randomly, like flipping a coin.

Do I have to live in France to join this study?

Yes, this particular study is taking place in four hospitals in France.

What kind of extra support will I get in the 'intervention' group?

You'll have special consultations after hospital discharge with a team including a nurse, dietitian, and pharmacist, plus follow-up appointments with a specialist nurse at 3, 6, and 12 months.

How to find out more

Youcef SEKOUR

youcef.sekour@aphp.fr 0033(0)156095823 Official trial record

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