ClinicalTrials.gg
RecruitingNCT06521047PERFECTUpdated Sep 25, 2024

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

An observational study in Acute Myocardial Infarction, sponsored by CellProthera. Recruiting at 10 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-25.

Sponsored by CellProthera · Observational

From the registry’s dates

  • Started Jul 2024; still recruiting 2 years 3 months later.
Study type
Observational
Model
Other
Time perspective
Other
Enrollment
48
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 168 studies in Myocardial Infarction with a site in France — 22 open to participants now, 31 under way, 7 of them phase 3. Myocardial Infarction · France.

Planned enrollment
49th of 54
48 · median 756
Started
2024
with 8 others
Observational
54 of 168
9 open now
Primary completion
2034-03
later than 29 of 30 live
Registered
157th of 168
by date

Among the 168 studies in Myocardial Infarction with a site in France, this one is the 49th largest by planned enrollment of the 54 observational ones that give a count, is one of 9 that started in 2024, is one of 54 observational ones, reaches primary completion later than 29 of the 30 other live ones, and was the 157th registered.

Myocardial Infarction

2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.

Browse Myocardial Infarction studies →

Open to participants now

22 of the 168 studies in Myocardial Infarction with a site in France are open now. Recruiting first, the newest first:

16 more — sign in →

All 22 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 255 Myocardial Infarction studies recruiting now, 172 (67%) set no upper age limit and 26 (10%) stop at 75 or younger; 16 take children under 18; 27 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 168 studies in Myocardial Infarction with a site in France, or all of them as a file.
02

Study summary

The PERFECT study is an observational study designed to follow patients randomised in the EXCELLENT study (NCT02669810) for 10 years.

The aim is to assess the long-term clinical outcomes for patients randomised to the Standard of Care arm or the ProtheraCytes arm.

03

Conditions studied

  • Acute Myocardial Infarction
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

To be eligible for this observational study, participants must have completed the last visit in the EXCELLENT interventional clinical trial.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Completion of the last visit in the EXCELLENT interventional clinical trial.
  • Participation must be within 10 years after the randomization in the EXCELLENT trial

Exclusion criteria

Exclusion criteria :

  • Patients randomized to the ProtheraCytes® group who did not receive the product of the EXCELLENT Trial are excluded.
  • Any other coexisting conditions that will preclude participation in the study or compromise ability to give
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Other
Time perspective
Other
Enrollment
48 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • Standard of Care

    Patients randomized in the standard of care arm in the EXCELLENT trial who have completed their 6-month follow-up visit

    Other: NA - Observational study

  • ProtheraCytes Arm

    Patients randomized in the ProtheraCytes arm in the EXCELLENT trial, who received an injection of ProtheraCytes and who have completed their 6-month follow-up visit

    Other: NA - Observational study

Interventions

  • OtherNA - Observational study

    Observational study, data collection only.

06

What researchers measure

Primary outcomes

  1. Comparison of the safety and efficacy of patients included in the Protheracytes arm versus the Standard of care arm

    The data collected for the efficacity part are cardiovascular markers : NT-Pro-BNP, LVESVI, LVEDVI, LVEF The data collected for the safety are : Occurence of Acute Heart failure, Acute MI, transplantation or MACE. All SAE/AE ongoing at or starting from the participant's last visit of the EXCELLENT clinical trial until 10 years after enrolment

    Time frame: Through study completion, an average of 10 year

07

Study locations

2 of 10 sites recruiting
  • GHRMSA
    Mulhouse, France 68100, France
    Active, not recruiting

    Not enrolling at this site.

  • CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel
    Dijon, 21079, France
    Active, not recruiting

    Not enrolling at this site.

  • Institut Jacques Cartier
    Massy, France
    Active, not recruiting

    Not enrolling at this site.

  • CHU Montpellier Arnaud-De-Villeneuve
    Montpellier, France
    Recruiting
    • François Roubille, MD · Contact
  • Hôpital Haut Levèque
    Pessac, France
    Active, not recruiting

    Not enrolling at this site.

  • Hôpital de Rangueil
    Toulouse, France
    Recruiting
    • Jérôme Roncalli, MD,PhD · Contact
    • Jérôme Roncalli, MD, PhD · Contact
  • Ninewells Hospital & Medical School
    Dundee, B15 2GW, United Kingdom
    Not yet recruiting
    • John Irving, MD · Contact
  • BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way,
    Edgbaston, B15 2GW, United Kingdom
    Not yet recruiting
  • University of Edinburgh
    Edinburgh, United Kingdom
    Not yet recruiting
    • David E Newby, MD PhD · Contact
  • Saint Bartholomew's Hospital W Smithfield,
    London, EC1A 7BE, United Kingdom
    Not yet recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jul 2024 (actual). Primary completion is estimated for Mar 2034, 115 months after the start.

Of 37 industry-sponsored observational studies under Myocardial Infarction, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 32. This study's planned 115 months is above that.

Counting every sponsor, half of 333 studies reached it within 48 months; a quarter within 17 and three quarters within 114.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 9, 2024
First posted
Jul 25, 2024
StartActual
Jul 20, 2024
Primary completionEst.
Mar 15, 2034
CompletionEst.
Mar 15, 2034
Last update
Sep 25, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06521047
Lead sponsor
CellProthera
Responsible party
Sponsor
First posted
Jul 25, 2024
Start date
Jul 20, 2024
Primary completion
Mar 15, 2034 (estimated)
Completion
Mar 15, 2034 (estimated)
Last update
Sep 25, 2024

Study contacts

Aude BOLLINGER, MSc
Contact
abollinger@cellprothera.com
+33-(3)-69-71-97-71
Louise BOUDEAU, PharmD
Contact
lboudeau@cellprothera.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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