Actively Recruiting
A Multicentre Observational Study to Assess Long-term Outcome of Participants in the EXCELLENT Clinical Trial
Led by CellProthera · Updated on 2024-09-25
48
Participants Needed
10
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to observe patients who participated in the EXCELLENT clinical trial for acute myocardial infarction. It focuses on comparing long-term clinical outcomes between those who received standard care and those treated with ProtheraCytes. The study is designed to follow these patients for up to 10 years to gather valuable safety and efficacy data. Participants include those from both the standard of care group and the ProtheraCytes treatment group who have completed their 6-month follow-up in the original EXCELLENT trial. This observational study involves collecting data without additional interventions or treatments. The study duration spans an average of 10 years from the initial randomization in the EXCELLENT trial. During the study, researchers will monitor participants regularly to assess safety and treatment outcomes over the long term. Data collection includes clinical evaluations and tracking of any health changes. The study does not involve new treatments but focuses on observing and comparing patient progress. Participants will continue their usual care outside the study, and their safety will be monitored throughout.
CONDITIONS
Brief Title
A Multicentre Observational Study to Assess Long-term Outcome of Participants in the EXCELLENT Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 10 years
Participants who completed the EXCELLENT trial are observed for long-term outcomes up to 10 years after randomization.
Trial Site Locations
Total: 10 locations
1
GHRMSA
Mulhouse, France, France, 68100
Active, Not Recruiting
2
CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel
Dijon, France, 21079
Active, Not Recruiting
3
Institut Jacques Cartier
Massy, France
Active, Not Recruiting
4
CHU Montpellier Arnaud-De-Villeneuve
Montpellier, France
Actively Recruiting
5
Hôpital Haut Levèque
Pessac, France
Active, Not Recruiting
6
Hôpital de Rangueil
Toulouse, France
Actively Recruiting
7
Ninewells Hospital & Medical School
Dundee, United Kingdom, B15 2GW
Not Yet Recruiting
8
BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way,
Edgbaston, United Kingdom, B15 2GW
Not Yet Recruiting
9
University of Edinburgh
Edinburgh, United Kingdom
Not Yet Recruiting
10
Saint Bartholomew's Hospital W Smithfield,
London, United Kingdom, EC1A 7BE
Not Yet Recruiting
Research Team
A
Aude BOLLINGER, MSc
L
Louise BOUDEAU, PharmD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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