RecruitingOBSERVATIONAL

A Multicentre Observational Study to Assess Long-term Outcome of Participants in the EXCELLENT Clinical Trial

The PERFECT study is an important follow-up to a previous study called EXCELLENT. If you participated in the EXCELLENT study, this new study aims to understand your long-term health over the next 10 years. Researchers want to see how people who received the standard treatment or a new treatment (ProtheraCytes) are doing a decade later. This helps us learn more about the best ways to care for people after a heart attack. It's an 'observational' study, meaning we won't give you any new medication or treatment; we'll simply collect information about your health over time. Your participation is valuable for future heart attack patients.

At a glance

Status

Recruiting

Sponsor

CellProthera

Enrolment target

Start

20 Jul 2024

Estimated completion

15 Mar 2034

Acute Myocardial Infarction

What is this study about?

You might remember taking part in a study called EXCELLENT after you had a heart attack. The PERFECT study is a follow-up to that earlier study. We want to understand how your health has been over the long term, specifically for 10 years after you were first involved in the EXCELLENT study. This kind of follow-up is really important because it helps doctors and researchers see the bigger picture of how treatments work over many years, not just a short period.

In the EXCELLENT study, some people received the usual care for a heart attack, and others received a new treatment called ProtheraCytes. By tracking both groups over a long time, we can compare their health outcomes. This helps us learn more about what made a difference and what might be the best way to help people recover and stay healthy after a heart attack in the future.

This is an 'observational' study. This means you won't be given any new medicines or treatments as part of PERFECT. Instead, we'll be collecting information about your health from your medical records and possibly asking you some questions. Your continued input helps us gain important knowledge that can improve care for countless others who experience heart attacks.

Key takeaways

This study follows people from a previous heart attack study (EXCELLENT).
It helps us understand long-term health after a heart attack for up to 10 years.
No new treatments or medications are given; it's an 'observational' study.
Your participation helps improve care for future heart attack patients.
You can withdraw from the study at any time.

Who may be eligible?

To join the PERFECT study, you must have previously participated in and completed all the visits for the EXCELLENT study. Also, it needs to be less than 10 years since you were first randomly assigned to a treatment group in the EXCELLENT study.

There are a few reasons why you might not be able to join. If you were in the EXCELLENT study's ProtheraCytes group but didn't actually receive the ProtheraCytes treatment, then you would not be eligible for this follow-up study. Also, if you have other serious health conditions that would make it difficult for you to take part or understand what the study involves, you might not be able to join.

The study is open to both men and women, aged 18 and over.

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.

Did you take part in the EXCELLENT study?
Did you complete all your visits for the EXCELLENT study?
Was it less than 10 years ago that you were first assigned a treatment in the EXCELLENT study?
Were you in the ProtheraCytes group in EXCELLENT and did actually receive the treatment?
Are you able to understand what the study involves and give your consent?

Answer every question to see your result.

What does participation involve?

As this is an observational study, taking part is generally quite simple and won't involve major changes to your routine. We won't be giving you any new medicines or treatments.

Your participation will mainly involve us gathering information about your health from your existing medical records over the next 10 years. It may also involve occasional check-ups or questionnaires to see how you are doing, but these will be planned to be as convenient as possible. The total duration of your involvement will be up to 10 years after your original date in the EXCELLENT study.

Potential risks and benefits

The main benefit of taking part is contributing to important medical research that will help improve care for future patients after a heart attack. There are very few direct risks as you won't be undergoing new treatments or procedures. The main potential risk is that sharing your health information, even though it will be kept highly confidential, always carries a very small risk. Remember, you can decide to stop participating in the study at any time, for any reason, without it affecting your medical care.

Locations (10)

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

GHRMSA
Verified postcode
Mulhouse, France· Active not recruiting
CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel
Verified postcode
Dijon, France· Active not recruiting
Institut Jacques Cartier
Verified postcode
Massy, France· Active not recruiting
CHU Montpellier Arnaud-De-Villeneuve
Verified postcode
Montpellier, France· Recruiting
Hôpital Haut Levèque
Verified postcode
Pessac, France· Active not recruiting
Hôpital de Rangueil
Verified postcode
Toulouse, France· Recruiting
Ninewells Hospital & Medical School
Verified postcode
Dundee, United Kingdom· Not yet recruiting
BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way,
Verified postcode
Edgbaston, United Kingdom· Not yet recruiting
University of Edinburgh
Verified postcode
Edinburgh, United Kingdom· Not yet recruiting
Saint Bartholomew's Hospital W Smithfield,
Verified postcode
London, United Kingdom· Not yet recruiting

Common questions

What is the PERFECT study about?

It's a follow-up study to the EXCELLENT study, tracking the long-term health of heart attack patients over 10 years.

Will I receive new treatment in this study?

No, this is an 'observational' study, so you won't get any new medicines or treatments.

How long will I be involved?

Your involvement will last up to 10 years from when you first joined the EXCELLENT study.

Who can join the PERFECT study?

You must have completed the EXCELLENT study and it must be less than 10 years since you joined it.

Can I stop participating if I change my mind?

Yes, you are free to withdraw from the study at any time without it affecting your medical care.

How to find out more

Aude BOLLINGER, MSc

abollinger@cellprothera.com +33-(3)-69-71-97-71 Official trial record

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