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

September 23, 2024 updated by: CellProthera

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

48

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Dijon, France, 21079
        • Active, not recruiting
        • CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel
      • Massy, France
        • Active, not recruiting
        • Institut Jacques Cartier
      • Montpellier, France
        • Recruiting
        • CHU Montpellier Arnaud-De-Villeneuve
        • Contact:
          • François Roubille, MD
      • Mulhouse, France, 68100
        • Active, not recruiting
        • GHRMSA
      • Pessac, France
        • Active, not recruiting
        • Hopital Haut Lévêque
      • Toulouse, France
        • Recruiting
        • Hopital de Rangueil
        • Contact:
          • Jérôme Roncalli, MD,PhD
        • Contact:
          • Jérôme Roncalli, MD, PhD
  • United Kingdom
      • Dundee, United Kingdom, B15 2GW
        • Not yet recruiting
        • Ninewells Hospital & Medical School
        • Contact:
          • John Irving, MD
      • Edgbaston, United Kingdom, B15 2GW
        • Not yet recruiting
        • BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way,
        • Contact:
      • Edinburgh, United Kingdom
        • Not yet recruiting
        • University of Edinburgh
        • Contact:
          • David E Newby, MD PhD
      • London, United Kingdom, EC1A 7BE
        • Not yet recruiting
        • Saint Bartholomew's Hospital W Smithfield,
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

To be eligible for this observational study, participants must have completed the last visit in the EXCELLENT interventional clinical trial.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Standard of Care
Patients randomized in the standard of care arm in the EXCELLENT trial who have completed their 6-month follow-up visit
Other: NA - Observational study
Observational study, data collection only.
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
Other: NA - Observational study
Observational study, data collection only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CellProthera

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 20, 2024

Primary Completion (Estimated)

March 15, 2034

Study Completion (Estimated)

March 15, 2034

Study Registration Dates

First Submitted

July 9, 2024

First Submitted That Met QC Criteria

July 22, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

September 25, 2024

Last Update Submitted That Met QC Criteria

September 23, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPT-MI-R01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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