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Pericardial Effusion From Acute Myocardial Infarction: Contributing Factors and Prognosis at One Year (EPERICARDIM)

NCT ID: NCT05146492

Last Updated: 2021-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-19

Study Completion Date

2024-07-19

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myocardial Infarction Pericardial Effusion

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Patient with acute myocardial infarction without pericardial effusion

Group Type ACTIVE_COMPARATOR

MRI

Intervention Type PROCEDURE

MRI with gadolinium contrast media injection

Patient with acute myocardial infarction and pericardial effusion

Group Type EXPERIMENTAL

MRI

Intervention Type PROCEDURE

MRI with gadolinium contrast media injection

Interventions

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MRI

MRI with gadolinium contrast media injection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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;
* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Clinical Trial Experts Network

OTHER

Sponsor Role collaborator

Ramsay Générale de Santé

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Private Hospital of Parly II-Le Chesnay

Le Chesnay, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Jean-François Oudet

Role: CONTACT

Phone: 0683346567

Email: [email protected]

Marie-Hélène Barba

Role: CONTACT

Email: [email protected]

Facility Contacts

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Jean-François Oudet

Role: primary

Marie-Hélène Barba

Role: backup

Other Identifiers

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2019-A02590-57

Identifier Type: -

Identifier Source: org_study_id