Acute Myocardial InfarctionPERFECTNCT06521047
A Multicentre Observational Study to Assess Long-term Outcome of Participants in the EXCELLENT Clinical Trial
An observational study of Acute Myocardial Infarction, run by CellProthera at 10 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- NA - Observational study
- Type of treatment
- Injection or infusion
- How many people
- 48 participants
- Where
- 10 sitesin 2 countries
- Study dates
- 20 Jul 2024to 15 Mar 2034
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: To be eligible for this observational study, participants must have completed the last visit in the EXCELLENT interventional clinical trial.
Who may be able to join
- Completion of the last visit in the EXCELLENT interventional clinical trial.
- Participation must be within 10 years after the randomization in the EXCELLENT trial
Who cannot join
- 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
Trial locations and contacts
10 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
Louise BOUDEAU, PharmD contact
10 sites in 2 countries
France6 sites, 2 recruiting
- Active, not recruiting
CHU DIJON Hôpital François Mitterrand 14 rue Gaffarel
Dijon, 21079
- Active, not recruiting
Institut Jacques Cartier
Massy
- Recruiting
CHU Montpellier Arnaud-De-Villeneuve
Montpellier
François Roubille, MD
- Active, not recruiting
GHRMSA
Mulhouse, France, 68100
- Active, not recruiting
Hôpital Haut Levèque
Pessac
- Recruiting
Hôpital de Rangueil
Toulouse
Jérôme Roncalli, MD,PhD
Jérôme Roncalli, MD, PhD
United Kingdom4 sites, 4 recruiting
- Not yet recruiting
Ninewells Hospital & Medical School
Dundee, B15 2GW
John Irving, MD
- Not yet recruiting
BIRMINGHAM, Queen Elizabeth Hospital ,Mindelsohn Way,
Edgbaston, B15 2GW
Sohail KHAN, MD, +44.121 371 4624, Sohail.Khan@uhb.nhs.uk
- Not yet recruiting
University of Edinburgh
Edinburgh
David E Newby, MD PhD
- Not yet recruiting
Saint Bartholomew's Hospital W Smithfield,
London, EC1A 7BE
Anthony MATHUR, MD, PhD, +44 20 3416 5000, a.mathur@qmul.ac.uk
About this study
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.
- Conditions
- Acute Myocardial Infarction
- Being tested
- NA - Observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NA - Observational studyOther
Observational study, data collection only.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Patients randomized in the standard of care arm in the EXCELLENT trial who have completed their 6-month follow-up visit Receives: Other: NA - Observational study | |
| 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 Receives: Other: NA - Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Through study completion, an average of 10 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start20 Jul 2024
- Primary completion15 Mar 2034 (estimated)
- Study completion15 Mar 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 48 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- CellProthera
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06521047
- Sponsor's protocol ID
- CPT-MI-R01
- Acronym
- PERFECT
- Status last verified
- Sep 2024
- First submitted
- 9 Jul 2024
- Last updated
- 25 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre Observational Study to Assess Long-term Outcome of Participants in the EXCELLENT Clinical Trial
- ClinicalTrials.gov ID
- NCT06521047
- Acronym / sponsor ID
- PERFECT / CPT-MI-R01
- Conditions
- Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- CellProtheraIndustry (pharma, biotech, devices)
- Study start
- 20 Jul 2024 (actual)
- Primary completion
- 15 Mar 2034 (estimated)
- Study completion
- 15 Mar 2034 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of Care | – | Other: NA - Observational studyPatients randomized in the standard of care arm in the EXCELLENT trial who have completed their 6-month follow-up visit |
| ProtheraCytes Arm | – | Other: NA - Observational studyPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- To be eligible for this observational study, participants must have completed the last visit in the EXCELLENT interventional clinical trial.
Key inclusion criteria (2 listed)
- Completion of the last visit in the EXCELLENT interventional clinical trial.
- Participation must be within 10 years after the randomization in the EXCELLENT trial
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NA - Observational studyObservational study, data collection only. | Other | ProtheraCytes Arm, Standard of Care |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Louise BOUDEAU, PharmD contact
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Myocardial Infarction, run by CellProthera at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in France, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aude BOLLINGER, MSc (+33-(3)-69-71-97-71, abollinger@cellprothera.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.