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

CellProthera

Status: Enrolling

Conditions: Acute Myocardial Infarction

Treatments: Other: NA - Observational study

Study type: Observational

Funder types: Industry

Identifiers

NCT06521047

CPT-MI-R01

Details and patient eligibility

About

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.

Enrollment: 48 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

48 participants in 2 patient groups

Standard of Care

Description:

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

Treatment:

Other: NA - Observational study

ProtheraCytes Arm

Description:

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

Treatment:

Other: NA - Observational study