CompletedNot Applicable

CMR Evaluation of Myocardial Inflammation Persistence After Acute Myocarditis: Prognostic Relevance

Italy80 participantsStarted 2016-12-06

Plain-language summary

Patients with acute myocarditis (AM) usually experience spontaneous healing, but a considerable percentage of them evolve towards chronic long-term cardiac impairment. The evolution towards dilated cardiomyopathy (DCM) occurs in a subtle manner, frequently after an initial recover that mimics complete healing. Differences in the course of the disease may reflect the course of underlying myocardial inflammation related to viral clearance or persistence and to the following autoimmune response. Cardiac magnetic resonance (CMR) mapping parameters have been developed for the quantification of edema and necrosis, showing high diagnostic accuracy. No mapping parameter has been developed for the assessment of the third Lake Louise criteria, namely the hyperemia, and, furthermore, their prognostic role is not completely understood. The study hypothesis is that the early-enhanced T1 mapping parameter may have great diagnostic accuracy for myocarditis, and that a short-term monitoring with a complete CMR protocol at 2 month after symptoms onset may identify the subgroup of patients at high risk of progression towards DCM. The results of this study will help to significantly improve diagnostic performances of CMR and may help to manage patients with AM.

Who can participate

Age range18 Years – 80 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Presence of at least 1 of the subsequent clinical features \[12\]: * Acute chest pain (pericarditic, or pseudo-ischaemic) * New-onset dyspnoea at rest or during exercise * Fatigue with or without left/right heart failure signs * Palpitation or unexplained arrhythmia symptoms or syncope or aborted sudden cardiac death * Unexplained cardiogenic shock * Associated with at least 1 of the subsequent diagnostic criteria \[12\]: * Newly abnormal 12 lead ECG and/or Holter and/or stress testing, any of the following: I to III degree atrioventricular block, or bundle branch block, ST/T wave change, sinus arrest, ventricular tachycardia or fibrillation and asystole, atrial fibrillation, reduced R wave height, intraventricular conduction delay, abnormal Q waves, low voltage, frequent premature beats, supraventricular tachycardia * Myocardial injury markers (elevated troponin T/Troponin I) * New, otherwise unexplained left ventricular (LV) and/or right ventricular (RV) functional and/or structural abnormalities on cardiac imaging (echo/angio/CMR) compatible with acute myocarditis and excluding other diseases * Signed informed consent Exclusion Criteria: * History of cardiomyopathies * Coronary artery disease (coronary catheterization or CT angiography will be performed when coronary artery disease need to be excluded in consideration of signs and symptoms) * ICD or pacemaker * Inability to hold breath or to lay down for 45 min * Claustrophobia * …

What they're measuring

Improvement in CMR diagnosis with early enhanced T1 mapping and early changes in CMR parameters reflecting inflammation activity

Timeframe: Baseline; 2 month

MACE and left ventricular remodelling

Timeframe: Inclusion; 2 month

Trial details

NCT IDNCT03525639

SponsorAntonio Esposito

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-12-31