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NCT Number: NCT06521047

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

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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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GHRMSA, Mulhouse, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NA - Observational study

Other

Observational study, data collection only.

Primary outcomes

  1. 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

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

CellProthera

Industry

Registry information

Acronym: PERFECT

Important dates

Study start
2024
Primary completion
2034
Study completion
2034
First posted
Jul 25, 2024
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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