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

NCT06521047 · tracked via the Priya Life Science UK tracker

Sponsor

CellProthera

Phase

Observational

Started

2024-07-20

Last updated

2024-09-25

Condition(s) studied

Acute Myocardial Infarction

Investigational drug(s) / intervention(s)

NA - Observational study

NA - Observational study: Observational study, data collection only.

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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 : * 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 informed consent

Primary outcome measure(s)

Comparison of the safety and efficacy of patients included in the Protheracytes arm versus the Standard of care arm — Through study completion, an average of 10 year
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

Trial sites (10)

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

Other trials for the same condition

Selatogrel Outcome Study in Suspected Acute Myocardial Infarction Enrolling by invitation

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06521047 on ClinicalTrials.gov ↗ ← All trials in the UK