Myocardial Inflammation Clinical Trial
— MIAMIOfficial title:
Cardiac Magnetic Resonance Evaluation of Myocardial Inflammation Persistence After Acute Myocarditis: Prognostic Relevance
Verified date | October 2019 |
Source | IRCCS San Raffaele |
Contact | Antonio Esposito |
esposito.antonio[@]unisr.it | |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 80 |
Est. completion date | August 31, 2020 |
Est. primary completion date | August 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Italy | IRCCS San Raffaele | Milano | |
Italy | Policlinico Umberto I | Roma | |
Italy | AOU Città della Salute e della Scienza | Torino |
Lead Sponsor | Collaborator |
---|---|
Antonio Esposito | Ministry of Health, Italy |
Italy,
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* Note: There are 21 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 |
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