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

NCT05146492 | Unknown

• 1 other identifier: 2019-A02590-57
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Myocardial Infarction; Pericardial Effusion

Outcome Measures

Primary Outcomes (1)

• One-year mortality rate of patients with pericardial effusion

  One-year mortality rate of patients with pericardial effusion

  1 year

Study Arms (2)

Patient with acute myocardial infarction without pericardial effusion

ACTIVE COMPARATOR

Procedure: MRI

Patient with acute myocardial infarction and pericardial effusion

EXPERIMENTAL

Procedure: MRI

Interventions

MRI PROCEDURE

MRI with gadolinium contrast media injection

Patient with acute myocardial infarction and pericardial effusion; Patient with acute myocardial infarction without pericardial effusion

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ramsay Générale de Santé: lead
• European Clinical Trial Experts Network: collaborator

Study Sites (1)

Private Hospital of Parly II-Le Chesnay

Le Chesnay, 78150, France

RECRUITING

MeSH Terms

Conditions

Pericardial Effusion

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Jean-François Oudet

CONTACT

0683346567; jf.oudet@ecten.eu

Marie-Hélène Barba

CONTACT

mh.barba@ecten.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 6, 2021
• Study Start: July 19, 2021
• Primary Completion: January 19, 2023
• Study Completion: July 19, 2024
• Last Updated: December 6, 2021

Record last verified: 2021-11

Locations

FR (1)