Hôpital Pitié-Salpêtrière
Paris, 75013, France
Location status: Recruiting
NCT Number: NCT04844151
The AMPHIBIA study is an observational ambispective and prospective cohort that aim to describe the histologic, immunologic, biological, imaging, genetic and clinical characteristics of the patients hospitalized for an acute myocarditis and to evaluate their association with prognosis.
Interested in participating?
Request Info15 year and older
All sexes
Observational
Paris, 75013, France
Location status: Recruiting
Acute myocarditis is an inflammatory disease of the heart muscle. Its clinical presentation and its etiologies are multiple and make it a complex disease to treat. Its course also varies, ranging from complete clinical recovery to recurrence of ventricular arrhythmia or progression to chronic dilated heart disease, while being difficult to predict. The long-term prognosis is poorly understood.
Consecutive patients hospitalized in a tertiary university referral center cohort from 2006 to 2041 for an acute myocarditis will be ambispectively or prospectively analyzed. This project will establish a registry including up to 400 patients in the ambispective analysis cohort from 2006 to 2021 and 1000 patients in the prospective analysis cohort during a 20 years inclusion period.
The aim of the study is to describe the characteristics of patients hospitalized for an acute myocarditis and to evaluate their association wih the long term (until 20 years) prognosis.
Features of interest will include :
The collection of clinical, biological and radiological data will represent an unique source allowing research teams in the coming years to access the data necessary to answer various specific questions (pathophysiological, diagnostic, prognostic) relevant to the state of knowledge on this pathology.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: up to 1 years
Defined as a composite of :
Time frame: up to 20 years
Defined as a composite of :
Time frame: up to 20 years
Time frame: up to 20 years
Time frame: up to 20 years
Number of patients with heart transplant
Time frame: up to 20 years
Number of patients with sustained ventricular arrhythmia after discharge
Time frame: up to 20 years
Number of patients with resuscitated cardiac arrest
Time frame: up to 20 years
Number of patients implanted with a longterm mechanical circulatory support
Time frame: up to 20 years
Number of patients hospitalized for myocarditis recurrence
Time frame: up to 20 years
Number of patients with hospitalization for heart failure
Time frame: up to 20 years
Number of patients with a surgery of pericardial drainage
Time frame: up to 20 years
Number of patients with a new onset of supra ventricular arrhythmia
Time frame: up to 20 years
Number of patients with a new high grade atrioventricular block
Time frame: up to 20 years
Number of patients with pericarditis diagnosed by the patient referring physician's
Time frame: up to 20 years
Evaluated by transthoracic echocardiography
Time frame: From the day of admission up to 90 days
Type and duration of therapeutics received during the initial hospital stay
Contact information is provided by the study sponsor or research team.
Assistance Publique - Hôpitaux de Paris
Other
Acronym: AMPHIBIA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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