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

R

Ramsay Générale de Santé

Status

Enrolling

Conditions

Pericardial Effusion
Acute Myocardial Infarction

Treatments

Procedure: MRI

Study type

Interventional

Funder types

Other

Identifiers

NCT05146492
2019-A02590-57

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Health Services Research

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Patient with acute myocardial infarction without pericardial effusion
Active Comparator group
Treatment:
Procedure: MRI
Patient with acute myocardial infarction and pericardial effusion
Experimental group
Treatment:
Procedure: MRI

Trial contacts and locations

1

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Central trial contact

Jean-François Oudet; Marie-Hélène Barba

Data sourced from clinicaltrials.gov

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