Clinical, Morphological and Functional Aspects in Myocarditis.
|ClinicalTrials.gov Identifier: NCT04217876|
Recruitment Status : Completed
First Posted : January 6, 2020
Last Update Posted : January 6, 2020
|Condition or disease||Intervention/treatment|
|Myocarditis||Diagnostic Test: post-processing analysis of cardiac imaging (strain echocardiography)|
|Study Type :||Observational|
|Actual Enrollment :||200 participants|
|Official Title:||Clinical, Morphological and Functional Aspects in Acute and Chronic Myocarditis.|
|Actual Study Start Date :||December 2016|
|Actual Primary Completion Date :||December 2019|
|Actual Study Completion Date :||December 2019|
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.
- Demonstrating incidence of longitudinal dysfunction of left ventricle in patients with acute myocarditis and preserved ejection fraction. [ Time Frame: 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. [ Time Frame: 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.
- Prognostic role of longitudinal dyfunction. [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04217876
|Milan, Italy, 20089|
|Pisa, Italy, 56126|
|Giovanni D Aquaro|
|Roma, Italy, 00177|
|Principal Investigator:||Gianluca Di Bella||University of Messina, Italy|
|Study Chair:||Mariapaola Campisi, MD||University of Messina, Italy|