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

Not Applicable

• Conditions: Pericardial Effusion; Acute Myocardial Infarction
• Interventions: Procedure: MRI

• Registration Number: NCT05146492
• Lead Sponsor: Ramsay Générale de Santé

Brief 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, 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

Not available

Study Timeline

• Study Start: 2021-07-19
• Status Verified: 2021-11
• Study First Submitted: 2021-11-25
• Study First Submitted QC: 2021-11-25
• Last Update Submitted: 2021-11-25
• Study First Posted: 2021-12-06
• Last Update Posted: 2021-12-06
• Primary Completion: 2023-01-19
• Study Completion: 2024-07-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient with acute myocardial infarction without pericardial effusion	MRI	-
Patient with acute myocardial infarction and pericardial effusion	MRI	-

Primary Outcome Measures

Name	Time	Method
One-year mortality rate of patients with pericardial effusion	1 year	One-year mortality rate of patients with pericardial effusion

Trial Locations

Locations (1)

Private Hospital of Parly II-Le Chesnay; 🇫🇷 Le Chesnay, France