Clinical, Morphological and Functional Aspects in Myocarditis.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Clinically suspected infarct-like acute myocarditis 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). |
Diagnostic Test: post-processing analysis of cardiac imaging (strain echocardiography)
A dedicated software package for two-dimensional speckle tracking strain analysis (XStrain™, Esaote, Florence, Italy) was used to quantify both ENDO and EPI strains. Our echocardiographic imaging acquisition protocol for 2DSTE consisted in the acquisition of three consecutive cardiac cycles from non-foreshortened apical views (4, 2, and 3 chambers) obtained during breath hold. Frame-by- frame displacement of ENDO and EPI points was automatically evaluated, generating strain curves for each segment.
The tracking quality was verified for each segment, and subsequent manual adjustments were performed, when required. All data were analyzed with the aid of Fourier techniques, which ensure greater accuracy using the periodicity of the heart motion.
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Outcome Measures
Primary Outcome Measures
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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diagnosis of clinical suspected acute myocarditis (AM)
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diagnosis of AM with cardiac magnetic resonance (CMR) according to Lake Louise criteria (myocardial edema, hyperemia, and LGE).
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Lorenzo Monti | Milan | Italy | 20089 | |
| 2 | Alessandro Pingitore | Pisa | Italy | 56126 | |
| 3 | Giovanni D Aquaro | Pisa | Italy | ||
| 4 | Giovanni Camastra | Roma | Italy | 00177 |
Sponsors and Collaborators
- University of Messina
- Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
- Humanitas Hospital, Italy
- Vannini Hospital Rome
Investigators
- Principal Investigator: Gianluca Di Bella, University of Messina, Italy
- Study Chair: Mariapaola Campisi, MD, University of Messina, Italy
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 11616