Recruiting NCT06521047
A Multicentre Observational Study to Assess Long-term Outcome of Participants in the EXCELLENT Clinical Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NA - Observational study.
- Who it may be relevant to
- Registry conditions: Acute Myocardial Infarction. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France, United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other NA - Observational study
Observational study, data collection only.
Primary outcome measures
- Comparison of the safety and efficacy of patients included in the Protheracytes arm versus the Standard of care arm [Time frame: Through study completion, an average of 10 year]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 6 centers
- GHRMSA — Mulhouse
- CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel — Dijon
- Institut Jacques Cartier — Massy
- CHU Montpellier Arnaud-De-Villeneuve — Montpellier
- Hôpital Haut Levèque — Pessac
- Hôpital de Rangueil — Toulouse
United Kingdom · 4 centers
- Ninewells Hospital & Medical School — Dundee
- BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way, — Edgbaston
- University of Edinburgh — Edinburgh
- Saint Bartholomew's Hospital W Smithfield, — London
Identifiers
NCT: NCT06521047 · CPT-MI-R01