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

Recruiting

• Conditions: Acute Myocardial Infarction
• Interventions: Other: NA - Observational study

• Registration Number: NCT06521047
• Lead Sponsor: CellProthera

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-20
• Status Verified: 2024-07
• Study First Submitted: 2024-07-09
• Study First Submitted QC: 2024-07-22
• Last Update Submitted: 2024-07-22
• Study First Posted: 2024-07-25
• Last Update Posted: 2024-07-25
• Primary Completion: 2034-03-15
• Study Completion: 2034-03-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 48

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard of Care	NA - Observational study	Patients randomized in the standard of care arm in the EXCELLENT trial who have completed their 6-month follow-up visit
ProtheraCytes Arm	NA - Observational study	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

Primary Outcome Measures

Name	Time	Method
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 Locations

Locations (10)

CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel; 🇫🇷 Dijon, France

Institut Jacques Cartier; 🇫🇷 Massy, France

Hôpital Haut Levèque; 🇫🇷 Pessac, France

CHU Montpellier Arnaud-De-Villeneuve; 🇫🇷 Montpellier, France

GHRMSA; 🇫🇷 Mulhouse, France

Hôpital de Rangueil; 🇫🇷 Toulouse, France

Ninewells Hospital & Medical School; 🇬🇧 Dundee, United Kingdom

BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way,; 🇬🇧 Edgbaston, United Kingdom

University of Edinburgh; 🇬🇧 Edinburgh, United Kingdom

Saint Bartholomew's Hospital W Smithfield,; 🇬🇧 London, United Kingdom