Pericardial Effusion From Acute Myocardial Infarction: Contributing Factors and Prognosis at One Year (EPERICARDIM) (EPERICARDIM)
Primary Purpose
Acute Myocardial Infarction, Pericardial Effusion
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional health services research trial for Acute Myocardial Infarction
Eligibility Criteria
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.
Sites / Locations
- Private Hospital of Parly II-Le ChesnayRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Patient with acute myocardial infarction without pericardial effusion
Patient with acute myocardial infarction and pericardial effusion
Arm Description
Outcomes
Primary Outcome Measures
One-year mortality rate of patients with pericardial effusion
One-year mortality rate of patients with pericardial effusion
Secondary Outcome Measures
Full Information
NCT ID
NCT05146492
First Posted
November 25, 2021
Last Updated
November 25, 2021
Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
1. Study Identification
Unique Protocol Identification Number
NCT05146492
Brief Title
Pericardial Effusion From Acute Myocardial Infarction: Contributing Factors and Prognosis at One Year (EPERICARDIM)
Acronym
EPERICARDIM
Official Title
Pericardial Effusion From Acute Myocardial Infarction: Contributing Factors and Prognosis at One Year (EPERICARDIM)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
January 19, 2023 (Anticipated)
Study Completion Date
July 19, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ramsay Générale de Santé
Collaborators
European Clinical Trial Experts Network
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction, Pericardial Effusion
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient with acute myocardial infarction without pericardial effusion
Arm Type
Active Comparator
Arm Title
Patient with acute myocardial infarction and pericardial effusion
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
MRI
Intervention Description
MRI with gadolinium contrast media injection
Primary Outcome Measure Information:
Title
One-year mortality rate of patients with pericardial effusion
Description
One-year mortality rate of patients with pericardial effusion
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jean-François Oudet
Phone
0683346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name or Official Title & Degree
Marie-Hélène Barba
Email
mh.barba@ecten.eu
Facility Information:
Facility Name
Private Hospital of Parly II-Le Chesnay
City
Le Chesnay
ZIP/Postal Code
78150
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-François Oudet
Phone
0683346567
Email
jf.oudet@ecten.eu
First Name & Middle Initial & Last Name & Degree
Marie-Hélène Barba
Email
mh.barba@ecten.eu
12. IPD Sharing Statement
Learn more about this trial
Pericardial Effusion From Acute Myocardial Infarction: Contributing Factors and Prognosis at One Year (EPERICARDIM)
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