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

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ClinicalTrials.gov Identifier: NCT03525639
Recruitment Status : Unknown
Verified October 2019 by Antonio Esposito, IRCCS San Raffaele.
Recruitment status was:  Recruiting
First Posted : May 15, 2018
Last Update Posted : October 8, 2019
Sponsor:
Collaborator:
Ministry of Health, Italy
Information provided by (Responsible Party):
Antonio Esposito, IRCCS San Raffaele

Study Description
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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.


Condition or disease Intervention/treatment Phase
Myocarditis Acute Myocardial Inflammation Diagnostic Test: Cardiac Magnetic Resonance Not Applicable

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Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Cardiac Magnetic Resonance Evaluation of Myocardial Inflammation Persistence After Acute Myocarditis: Prognostic Relevance
Actual Study Start Date : December 6, 2016
Estimated Primary Completion Date : August 31, 2020
Estimated Study Completion Date : August 31, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Patients with Acute Myocarditis
Patients undergoing Cardiac Magnetic Resonance at baseline, 2 month, 1 year.
 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).


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in CMR diagnosis with early enhanced T1 mapping and early changes in CMR parameters reflecting inflammation activity [ Time Frame: Baseline; 2 month ]
    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).

  2. MACE and left ventricular remodelling [ Time Frame: Inclusion; 2 month ]

    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).



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03525639


Contacts
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Contact: Antonio Esposito esposito.antonio@unisr.it
Contact: Anna Palmisano palmisano.anna@hsr.it

Locations
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Italy
IRCCS San Raffaele Recruiting
Milano, Italy, 20132
Contact: Antonio Esposito         
Policlinico Umberto I Recruiting
Roma, Italy
Contact: Nicola Galea         
AOU Città della Salute e della Scienza Recruiting
Torino, Italy
Contact: Riccardo Faletti         
Sponsors and Collaborators
Antonio Esposito
Ministry of Health, Italy
Investigators
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Principal Investigator: Antonio Esposito IRCCS San Raffaele
More Information
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Publications:

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Responsible Party: Antonio Esposito, Professor, IRCCS San Raffaele
ClinicalTrials.gov Identifier: NCT03525639    
Other Study ID Numbers: MIAMI GR-2013-02356832
First Posted: May 15, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Antonio Esposito, IRCCS San Raffaele:
Cardiac Magnetic Resonance
Acute Myocarditis
Myocardial Inflammation
Additional relevant MeSH terms:
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Myocarditis
Inflammation
Pathologic Processes
 Cardiomyopathies
Heart Diseases
Cardiovascular Diseases