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

November 25, 2021 updated by: Ramsay Générale de Santé
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Le Chesnay, France, 78150
        • Recruiting
        • Private Hospital of Parly II-Le Chesnay

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patient with acute myocardial infarction without pericardial effusion
Procedure: MRI
MRI with gadolinium contrast media injection
Experimental: Patient with acute myocardial infarction and pericardial effusion
Procedure: MRI
MRI with gadolinium contrast media injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
One-year mortality rate of patients with pericardial effusion
Time Frame: 1 year
One-year mortality rate of patients with pericardial effusion
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramsay Générale de Santé

Collaborators

European Clinical Trial Experts Network

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 19, 2021

Primary Completion (Anticipated)

January 19, 2023

Study Completion (Anticipated)

July 19, 2024

Study Registration Dates

First Submitted

November 25, 2021

First Submitted That Met QC Criteria

November 25, 2021

First Posted (Actual)

December 6, 2021

Study Record Updates

Last Update Posted (Actual)

December 6, 2021

Last Update Submitted That Met QC Criteria

November 25, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A02590-57

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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