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Clinical, Morphological and Functional Aspects in Myocarditis.

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ClinicalTrials.gov Identifier: NCT04217876
Recruitment Status : Completed
First Posted : January 6, 2020
Last Update Posted : January 6, 2020
Sponsor:
Collaborators:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Humanitas Hospital, Italy
Vannini Hospital Rome
Information provided by (Responsible Party):
Gianluca Di Bella, University of Messina

Tracking Information
First Submitted Date December 28, 2019
First Posted Date January 6, 2020
Last Update Posted Date January 6, 2020
Actual Study Start Date December 2016
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 31, 2019)
  • 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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: December 31, 2019)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Clinical, Morphological and Functional Aspects in Myocarditis.
Official Title Clinical, Morphological and Functional Aspects in Acute and Chronic Myocarditis.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Consecutive in-patients with a definite CMR diagnosis of AM having a follow-up CMR examination including cine CMR, T1, T2 weighted and LGE images.
Condition Myocarditis
Intervention 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.

Study Groups/Cohorts 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).
Intervention: Diagnostic Test: post-processing analysis of cardiac imaging (strain echocardiography)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 31, 2019)
200
Original Actual Enrollment Same as current
Actual Study Completion Date December 2019
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT04217876
Other Study ID Numbers 11616
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Gianluca Di Bella, University of Messina
Study Sponsor University of Messina
Collaborators
  • 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
PRS Account University of Messina
Verification Date December 2019