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

NCT03525639 | Completed

• 1 other identifier: MIAMI GR-2013-02356832
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 3

Brief 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

Keywords

Cardiac Magnetic Resonance; Acute Myocarditis; Myocardial Inflammation

Outcome Measures

Primary Outcomes (2)

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

  T2 ratio; LGE (Late Gadolinium Enhancement); native T1 relaxation time; T2 relaxation time; extracellular volume fraction (ECV); early enhanced T1 relaxation time; baseline; 2 month; delta (2 month - baseline).

  Baseline; 2 month

• MACE and left ventricular remodelling

  Major adverse cardiac events (MACE): cardiac death; aborted sudden cardiac death; all-cause mortality. Left ventricular end-diastolic volume (LV EDV); left ventricular ejection fraction (LVEF).

  Inclusion; 2 month

Study Arms (1)

Patients with Acute Myocarditis

EXPERIMENTAL

Patients undergoing Cardiac Magnetic Resonance at baseline, 2 month, 1 year.

Diagnostic Test: Cardiac Magnetic Resonance

Interventions

Cardiac Magnetic Resonance DIAGNOSTIC_TEST

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

Patients with Acute Myocarditis

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Recent history of alimentary/alcoholic/respiratory intoxication
• CMR diagnostic criteria suggestive of other cardiac disease explaining signs and symptoms (e.g. myocardial infarction with patent coronary arteries, tako-tsubo syndrome)
• Risk for nephrogenic systemic fibrosis (estimated glomerular filtration rate \< 30 mL/min/1.73 m2)
• History of allergic reaction to MR contrast media
• Pregnancy or breast-feeding

Sponsors & Collaborators

• Antonio Esposito: lead
• Ministry of Health, Italy: collaborator

Study Sites (3)

IRCCS San Raffaele

Milan, 20132, Italy

Location

Policlinico Umberto I

Roma, Italy

Location

AOU Città della Salute e della Scienza

Torino, Italy

Location

Related Publications (21)

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MeSH Terms

Conditions

Myocarditis

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases

Study Officials

• Antonio Esposito

  IRCCS San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 3, 2018
• First Posted: May 15, 2018
• Study Start: December 6, 2016
• Primary Completion: December 31, 2020
• Study Completion: February 20, 2021
• Last Updated: May 1, 2025

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)