Clinical, Morphological and Functional Aspects in Myocarditis.

University of Messina

Status: Completed

Conditions: Myocarditis

Treatments: Diagnostic Test: post-processing analysis of cardiac imaging (strain echocardiography)

Study type: Observational

Funder types: Other

Identifiers

NCT04217876

11616 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 1 patient group

Clinically suspected infarct-like acute myocarditis

Description:

Diagnosis of infarct-like AM was based on five criteria: (a) history of flu-like symptoms within 8 weeks prior admission; (b) new onset of symptoms such as fatigue/breathlessness, chest pain, mild dyspnea, and/or palpitation; (c) ischemic ECG pattern (ST-segment elevation and/or T-wave anomalies); (d) increase of inflammatory markers (non-high- sensitivity CRP \> 8 mg/L and/or white blood cell count \> 11.000/mm3) and cardiac enzymes; and (e) preserved global systolic function (EF \> 50%). We excluded patients with New York Heart Association (NYHA) functional heart classifications II-IV, LVEF \< 50% and those patients with electrocardiographic evidence of bradyarrhythmias (≥second-degree atrioventricular block) or tachyarrhythmias (ventricular or supraventricular arrhythmias).

Treatment:

Diagnostic Test: post-processing analysis of cardiac imaging (strain echocardiography)