Clinical trial NCT04217876: Clinical, Morphological and Functional Aspects in Myocarditis.
Official title: Clinical, Morphological and Functional Aspects in Acute and Chronic Myocarditis.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myocarditis
Keywords: echocardiography
cardiac magnetic resonance
myocarditis
Lead sponsor: University of Messina
Sponsor class: OTHER
Collaborators: name: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
name: Humanitas Hospital, Italy
name: Vannini Hospital Rome
First posted: 2020-01-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive in-patients with a definite CMR diagnosis of AM having a follow-up CMR examination including cine CMR, T1, T2 weighted and LGE images.

Brief summary: Cardiac magnetic resonance (CMR) is accurate to identify acute myocardial damage (edema, hyperemia, and/or fibrosis) due to acute myocarditis (AM). Recently, two-dimensional strain echocardiography was also validated in order to provide important information on myocardial dysfunction in patients with AM, even if no wall motion abnormalities are detected. No data are available about incidence of longitudinal myocardial dysfunction and its prognostic role in AM.

Detailed description: In this study, the investigators will analyze the effect of acute myocarditis-induced damage on LV myocardial deformation and remodeling both in the acute myocarditis phase and follow-up period (about 2 years later). The investigators will use a combined approach including strain echocardiography to asses left ventricular myocardial deformation and late gadolinium enhancement (LGE)cardiac magnetic resonance for the assessment of left ventricular damage.

Eligibility criteria: Inclusion Criteria:

* diagnosis of clinical suspected acute myocarditis (AM)
* diagnosis of AM with cardiac magnetic resonance (CMR) according to Lake Louise criteria (myocardial edema, hyperemia, and LGE).
* absence of coronary artery diseases confirmed by coronary angiography or computed tomography in all patients with the exception of those younger than 30 years with a low risk of coronary artery disease.

Exclusion Criteria:

* Previous heart diseases

Primary outcomes:
measure: Demonstrating incidence of longitudinal dysfunction of left ventricle in patients with acute myocarditis and preserved ejection fraction.
timeFrame: Day 0
measure: Demonstrating effect of myocarditis damage due to myocardial fibrosis on longitudinal function.
timeFrame: Day 0
Secondary outcomes:
measure: Prognostic role of longitudinal dyfunction.
timeFrame: from 6-60 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Lorenzo Monti
city: Pisa
country: Italy
facility: Alessandro Pingitore
city: Pisa
country: Italy
facility: Giovanni D Aquaro
city: Roma
country: Italy
facility: Giovanni Camastra
Study officials:
affiliation: University of Messina, Italy
name: Gianluca Di Bella
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Messina, Italy
name: Mariapaola Campisi, MD
role: STUDY_CHAIR
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