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 range

18 Years – 80 Years

Sex

ALL

See this in plain English?

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 * …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Myocarditis Acute trials