Acute Myocardial InfarctionEPERICARDIMNCT05146492
Pericardial Effusion From Acute Myocardial Infarction: Contributing Factors and Prognosis at One Year (EPERICARDIM)
A study testing MRI in people with Acute Myocardial Infarction and Pericardial Effusion, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
Trial summary
This study aims to clarify, in patients with more or less abundant pericardial effusion in the acute phase of a myocardial infarction, the correlation between the existence of this effusion during the acute phase with clinical parameters, biological, angiographic, therapeutic and with transmurality, extent… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Acute Myocardial Infarction, Pericardial Effusion
- What is being tested?
- MRI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 19 Jul 2021to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient between 18 and 90 years old
- Patient admitted to the acute or semi-recent phase (within the next fifteen days) of a myocardial infarction (primary or recurrent myocardial infarction) documented by a significant enzymatic release of troponin (threshold value at 100) in the course of: chest pain or shock, or flare-up of heart failure (left or global) or successfully resuscitated cardiac arrest, or paroxysmal ventricular arrhythmia with or without sus shift of the ST segment on the input trace, with or without Q wave of necrosis formed. This IDM may or may not be complicated by a more or less abundant pericardial effusion of more than 10 mm in the left parasternal, which may in the extreme be the cause of tamponade;
- Subject affiliated or beneficiary of a social security scheme;
- Patient having signed the free and informed consent.
Who cannot join
- Patient with a pericardial detachment of less than 10 mm, or only systolic;
- Patient who had a break-in during the primary angioplasty guide or complicated coronary dissection extravasation with secondary pericardial effusion;
- Patient with advanced chronic renal failure
- Patient unable to perform an MRI (with a defibrillator or pacemaker).
- Known allergy to contrast agents, in particular gadolinium
- claustrophobic patient;
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- Protected patient: adult under guardianship or other legal protection, deprived of liberty by judicial or administrative decision;
- Pregnant or breastfeeding woman;
- Patient hospitalized without consent.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to clarify, in patients with more or less abundant pericardial effusion in the acute phase of a myocardial infarction, the correlation between the existence of this effusion during the acute phase with clinical parameters, biological, angiographic, therapeutic and with transmurality, extent, microvascular obstruction and intra myocardial hemorrhage found on MRI made beyond one week and before the 3rd month of the constitution of the necrosis.
- Conditions
- Acute Myocardial Infarction, Pericardial Effusion
- Being tested
- MRI
- Medical subject headings
- Pericardial Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIProcedure or surgery
MRI with gadolinium contrast media injection
| Study group | Role | What they receive |
|---|---|---|
| Patient with acute myocardial infarction without pericardial effusion | Active comparator | Not described Receives: Procedure: MRI |
| Patient with acute myocardial infarction and pericardial effusion | Experimental | Not described Receives: Procedure: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year mortality rate of patients with pericardial effusion
One-year mortality rate of patients with pericardial effusion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start19 Jul 2021
- Primary completion31 Jan 2024
- Study completion29 Feb 2024
Why it stopped: recruitment difficulty
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.
- More trials run by GCS Ramsay Santé pour l'Enseignement et la RechercheThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146492
- Sponsor's protocol ID
- 2019-A02590-57
- Acronym
- EPERICARDIM
- Status last verified
- Jul 2026
- First submitted
- 25 Nov 2021
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pericardial Effusion From Acute Myocardial Infarction: Contributing Factors and Prognosis at One Year (EPERICARDIM)
- ClinicalTrials.gov ID
- NCT05146492
- Acronym / sponsor ID
- EPERICARDIM / 2019-A02590-57
- Conditions
- Acute Myocardial Infarction, Pericardial Effusion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: recruitment difficulty
- Enrolment
- 3 participants (actual)
- Lead sponsor
- GCS Ramsay Santé pour l'Enseignement et la RechercheUniversity, hospital or other
- Collaborators
- European Clinical Trial Experts Network
- Study start
- 19 Jul 2021 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 29 Feb 2024 (actual)
- First posted
- 6 Dec 2021 (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.
This study aims to clarify, in patients with more or less abundant pericardial effusion in the acute phase of a myocardial infarction, the correlation between the existence of this effusion during the acute phase with clinical parameters, biological, angiographic, therapeutic and with transmurality, extent, microvascular obstruction and intra myocardial hemorrhage found on MRI made beyond one week and before the 3rd month of the constitution of the necrosis.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient with acute myocardial infarction without pericardial effusion | Active comparator | Procedure: MRI |
| Patient with acute myocardial infarction and pericardial effusion | Experimental | Procedure: MRI |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patient between 18 and 90 years old
- Patient admitted to the acute or semi-recent phase (within the next fifteen days) of a myocardial infarction (primary or recurrent myocardial infarction) documented by a significant enzymatic release of troponin (threshold value at 100) in the course of: chest pain or shock, or flare-up of heart failure (left or global) or successfully resuscitated cardiac arrest, or paroxysmal ventricular arrhythmia with or without sus shift of the ST segment on the input trace, with or without Q wave of necrosis formed. This IDM may or may not be complicated by a more or less abundant pericardial effusion of more than 10 mm in the left parasternal, which may in the extreme be the cause of tamponade;
- Subject affiliated or beneficiary of a social security scheme;
- Patient having signed the free and informed consent.
Key exclusion criteria (9 listed)
- Patient with a pericardial detachment of less than 10 mm, or only systolic;
- Patient who had a break-in during the primary angioplasty guide or complicated coronary dissection extravasation with secondary pericardial effusion;
- Patient with advanced chronic renal failure
- Patient unable to perform an MRI (with a defibrillator or pacemaker).
- Known allergy to contrast agents, in particular gadolinium
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 |
|---|---|---|
| MRIMRI with gadolinium contrast media injection | Procedure or surgery | Patient with acute myocardial infarction and pericardial effusion, Patient with acute myocardial infarction without pericardial effusion |
Primary outcome
One-year mortality rate of patients with pericardial effusion
Time frame: 1 year
One-year mortality rate of patients with pericardial effusion
Results and safety
The study was stopped early (reason given: recruitment difficulty). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Acute Myocardial Infarction and Pericardial Effusion, run by GCS Ramsay Santé pour l'Enseignement et la Recherche at 1 site in France.
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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study was stopped early (reason given: recruitment difficulty). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year mortality rate of patients with pericardial effusion (time frame: 1 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 16 Jul 2026.