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NCT03525639: MIAMI
CMR Evaluation of Myocardial Inflammation Persistence After Acute Myocarditis: Prognostic Relevance
NA trial testing Cardiac Magnetic Resonance in Myocarditis Acute in 80 participants. Completed in 20 February 2021.
31 December 2020
Quick facts
| Lead sponsor | Antonio Esposito |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | diagnostic |
| Enrollment | 80 |
| Start date | 6 December 2016 |
| Primary completion | 31 December 2020 |
| Estimated completion | 20 February 2021 |
| Sites | 3 locations across Italy |
Drugs / interventions tested
- Cardiac Magnetic Resonance
Conditions studied
- Myocarditis Acute — all drugs for Myocarditis Acute →
- Myocardial Inflammation — all drugs for Myocardial Inflammation →
Sponsor
Antonio Esposito
Who can join
Adults 18 to 80, any sex, with Myocarditis Acute or Myocardial Inflammation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03525639
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Cardiac Magnetic Resonance
Trials testing the same drug.
- NCT06020209 — CCT for Comprehensive Risk Stratification Following STEMI · NA · recruiting
- NCT05006443 — Staging Classification of Severe Tricuspid Regurgitation Using Novel Cardiac Imaging Techniques · NA · completed
- NCT04880317 — Validation of Quantitative Myocardial Tissue Characterization Through Non-gated CT · NA · terminated
- NCT03415789 — Intraventricular Stasis in Non Ischemic Dilated Myocardiopathy · completed
- NCT03263728 — Cardiac Magnetic Resonance for Asymptomatic Type 2 Diabetics With Cardiovascular High Risk (CATCH) - Pilot Study · NA · completed
Other recruiting trials for Myocarditis Acute
Currently open trials in the same condition.
- NCT06898762 — Creation of a National Multicenter Platform for the Study of Inflammatory Myocardial Disease: Pre-MYO Cohort · recruiting
- NCT05335928 — Abatacept in Immune Checkpoint Inhibitor Myocarditis · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03525639 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Antonio Esposito
- Last refreshed: 1 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03525639.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing