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

Acute Myocardial Infarction Clinical Trial

— EPERICARDIM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05146492
• Other study ID #: 2019-A02590-57
• Status: Recruiting
• Phase: N/A
• Start date: July 19, 2021
• Est. completion date: July 19, 2024

Study information

• Verified date: November 2021
• Source: Ramsay Générale de Santé
• Contact: Jean-François Oudet
• Phone: 0683346567
• Email: jf.oudet[@]ecten.eu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, microvascular obstruction and intra myocardial hemorrhage found on MRI made beyond one week and before the 3rd month of the constitution of the necrosis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 19, 2024
• Est. primary completion date: January 19, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• Pericardial Effusion

Intervention

Procedure:
• MRI
MRI with gadolinium contrast media injection

Locations

Country	Name	City	State
France	Private Hospital of Parly II-Le Chesnay	Le Chesnay

Sponsors (2)

Lead Sponsor	Collaborator
Ramsay Générale de Santé	European Clinical Trial Experts Network

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	One-year mortality rate of patients with pericardial effusion	One-year mortality rate of patients with pericardial effusion	1 year