A Multicentre Observational Study to Assess Long-term Outcome of Participants in the EXCELLENT Clinical Trial
PERFECT
1 other identifier
observational
48
2 countries
10
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jul 2024
Longer than P75 for all trials
10 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 9, 2024
CompletedStudy Start
First participant enrolled
July 20, 2024
CompletedFirst Posted
Study publicly available on registry
July 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 15, 2034
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 15, 2034
September 25, 2024
September 1, 2024
9.7 years
July 9, 2024
September 23, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Comparison of the safety and efficacy of patients included in the Protheracytes arm versus the Standard of care arm
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
Through study completion, an average of 10 year
Study Arms (2)
Standard of Care
Patients randomized in the standard of care arm in the EXCELLENT trial who have completed their 6-month follow-up visit
ProtheraCytes Arm
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
Interventions
Observational study, data collection only.
Eligibility Criteria
To be eligible for this observational study, participants must have completed the last visit in the EXCELLENT interventional clinical trial.
You may qualify if:
- Completion of the last visit in the EXCELLENT interventional clinical trial.
- Participation must be within 10 years after the randomization in the EXCELLENT trial
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- CellProtheralead
Study Sites (10)
GHRMSA
Mulhouse, France, 68100, France
CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel
Dijon, 21079, France
Institut Jacques Cartier
Massy, France
CHU Montpellier Arnaud-De-Villeneuve
Montpellier, France
Hôpital Haut Levèque
Pessac, France
Hôpital de Rangueil
Toulouse, France
Ninewells Hospital & Medical School
Dundee, B15 2GW, United Kingdom
BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way,
Edgbaston, B15 2GW, United Kingdom
University of Edinburgh
Edinburgh, United Kingdom
Saint Bartholomew's Hospital W Smithfield,
London, EC1A 7BE, United Kingdom
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- OTHER
- Target Duration
- 10 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 9, 2024
First Posted
July 25, 2024
Study Start
July 20, 2024
Primary Completion (Estimated)
March 15, 2034
Study Completion (Estimated)
March 15, 2034
Last Updated
September 25, 2024
Record last verified: 2024-09