Clinical, Morphological and Functional Aspects in Myocarditis.

Completed

• Conditions: Myocarditis

• Registration Number: NCT04217876
• Lead Sponsor: University of Messina

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.

Study Timeline

• Study Start: 2016-12
• Status Verified: 2019-12
• Primary Completion: 2019-12
• Study Completion: 2019-12
• Study First Submitted: 2019-12-28
• Study First Submitted QC: 2019-12-31
• Last Update Submitted: 2019-12-31
• Study First Posted: 2020-01-06
• Last Update Posted: 2020-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Demonstrating incidence of longitudinal dysfunction of left ventricle in patients with acute myocarditis and preserved ejection fraction.	Day 0	Longitudinal systolic function (s-1) of the left ventricle will be measured (%) by echocardiography.
Demonstrating effect of myocarditis damage due to myocardial fibrosis on longitudinal function.	Day 0	Longitudinal systolic function (s-1) of the left ventricle will be measured (%) by echocardiography.; Myocardial fibrosis LGE was defined as myocardium with an signal intensity higher than the average signal intensity of the region of interest more than 6 standard deviation in late gadolinium enhancement technique.

Secondary Outcome Measures

Name	Time	Method
Prognostic role of longitudinal dyfunction.	from 6-60 months	cardiac death, resuscitated cardiac arrest, ventricular assist device implantation, cardiac transplantation, appropriate implantable cardioverter defibrillator (ICD) shock, relapse of AM and hospitalization for worsening heart failure

Trial Locations

Locations (4)

Lorenzo Monti; 🇮🇹 Milan, Italy

Alessandro Pingitore; 🇮🇹 Pisa, Italy

Giovanni D Aquaro; 🇮🇹 Pisa, Italy

Giovanni Camastra; 🇮🇹 Roma, Italy