Clinical, Morphological and Functional Aspects in Myocarditis.
- Conditions
- Myocarditis
- Interventions
- Diagnostic Test: post-processing analysis of cardiac imaging (strain echocardiography)
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
- 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.
- Previous heart diseases
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Clinically suspected infarct-like acute myocarditis post-processing analysis of cardiac imaging (strain echocardiography) 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).
- 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)
Giovanni D Aquaro
🇮🇹Pisa, Italy
Giovanni Camastra
🇮🇹Roma, Italy
Alessandro Pingitore
🇮🇹Pisa, Italy
Lorenzo Monti
🇮🇹Milan, Italy