Acute Myocardial Infarction
Conditions
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.
Interventions
OTHERNA - Observational study
Observational study, data collection only.
Sponsors
CellProthera
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
France, United Kingdom
Contacts
Primary ContactAude BOLLINGER, MSc
Backup ContactLouise BOUDEAU, PharmD
Outcome results
None listed