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

NCT03525639 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-05-01

No results posted yet for this study

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.

Conditions

  • Myocarditis Acute
  • Myocardial Inflammation

Interventions

DIAGNOSTIC_TEST

Cardiac Magnetic Resonance

Additional CMR study 2 month after the initial diagnosis of acute myocarditis to assess myocardial inflammation persistence (2-month-CMR).

Sponsors & Collaborators

  • Ministry of Health, Italy

    collaborator OTHER_GOV

  • Antonio Esposito

    lead OTHER

Principal Investigators

  • Antonio Esposito · IRCCS San Raffaele

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-06
Primary Completion
2020-12-31
Completion
2021-02-20

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03525639 on ClinicalTrials.gov