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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NA - Observational study | Other | Observational study, data collection only. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion criteria :
Exclusion criteria :
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To be eligible for this observational study, participants must have completed the last visit in the EXCELLENT interventional clinical trial.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Aude BOLLINGER, MSc | Contact | +33-(3)-69-71-97-71 | abollinger@cellprothera.com | |
| Louise BOUDEAU, PharmD | Contact | lboudeau@cellprothera.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GHRMSA | Active, not recruiting | Mulhouse | France | 68100 | France | |
| CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel |
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| Active, not recruiting |
| Dijon |
| 21079 |
| France |
| Institut Jacques Cartier | Active, not recruiting | Massy | France |
| CHU Montpellier Arnaud-De-Villeneuve | Recruiting | Montpellier | France |
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| Hôpital Haut Levèque | Active, not recruiting | Pessac | France |
| Hôpital de Rangueil | Recruiting | Toulouse | France |
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| Ninewells Hospital & Medical School | Not yet recruiting | Dundee | B15 2GW | United Kingdom |
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| BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way, | Not yet recruiting | Edgbaston | B15 2GW | United Kingdom |
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| University of Edinburgh | Not yet recruiting | Edinburgh | United Kingdom |
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| Saint Bartholomew's Hospital W Smithfield, | Not yet recruiting | London | EC1A 7BE | United Kingdom |
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