Clinical trial NCT04521790: Role of Endomyocardial Biopsy and Aetiology-based Treatment in Patients With Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management
Official title: Role of Endomyocardial Biopsy and Aetiology-based Treatment in Patients With Inflammatory Heart Disease in Arrhythmic and Non-arrhythmic Clinical Presentations: an Integrated Approach for the Optimal Diagnostic and Therapeutic Management
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Myocarditis
Ventricular Arrythmia
Inflammatory Cardiomyopathy
Genetic Predisposition
Autoimmunity
Arrhythmia
Cardiomyopathies
Immunosuppression
Catheter Ablation
Keywords: Myocarditis
Ventricular arrhythmias
Arrhythmias
Arrhythmogenic inflammatory cardiomyopathy
Endomyocardial biopsy
Cardiac magnetic resonance
Ablation
Positron emission tomography
Cardiac imaging
Electroanatomical mapping
Immunosuppressive therapy
Arrhythmic risk stratification
Genetic predisposition
Environment
Implantable cardioverter defibrillator
Implantable loop recorder
Multicenter
Lead sponsor: Scientific Institute San Raffaele
Sponsor class: OTHER
First posted: 2020-08-21
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will enroll adult patients (age ≥ 18 y), of any gender or ethnic group, evaulated for clinically suspected myocarditis. Patients can be enrolled from any medical environment or department, including inpatients, outpatients, and patients transferred from other hospitals. The same inclusion criteria of the original single-center protocol will apply to the entire multicenter study.

Brief summary: Myocarditis is a complex inflammatory disease, usually occurring secondary to viral infections, autoimmune processes or toxic agents. Clinical presentations are multiple, including chest-pain, heart failure and a broad spectrum of arrhythmias. In turn, outcome is largely unpredictable, ranging from mild self-limiting disease, to chronic stage and progressive evolution towards dilated cardiomyopathy, to rapid adverse outcome in fulminant forms. Subsequently, myocarditis is often underdiagnosed and undertreated, and optimal diagnostic and therapeutic strategies are still to be defined. This study, both retrospective and prospective, originally single-center and subsequently upgraded to multicenter, aims at answering multiple questions about myocarditis, with special attention to its arrhythmic manifestations.

1. Optimal diagnostic workflow is still to be defined. In fact, although endomyocardial biopsy (EMB) is still the diagnostic gold standard, especially for aetiology identification, it is an invasive technique. Furthermore, it may lack sensitivity because of sampling errors. By converse, modern imaging techniques - cardiac magnetic resonance (CMR) in particular - have been proposed as alternative or complementary diagnostic tool in inflammatory heart disease. Other noninvasive diagnostic techniques, like delayed-enhanced CT (DECT) scan or position emission tomography (PET) scan, are under investigation.
2. Biomarkers to identify myocarditis aetiology, predisposition, prognosis and response to treatment are still to be defined.
3. Arrhythmic myocarditis is largely underdiagnosed and uninvestigated. Importantly, myocarditis presenting with arrhythmias requires specific diagnostic, prognostic and therapeutic considerations. At the group leader hospital, which is an international referral center for ventricular arrhythmias management and ablation, a relevant number of patients with unexplained arrhythmias had myocarditis as underlying aetiology. The experience of a dedicated third-level center is going to be shared with other centers, to considerably improve knowledge and management of arrhythmic myocarditis.
4. The role of CMR, as well as alternative noninvasive imaging techniques, in defining myocarditis healing is a relevant issue. In particular, optimal timing for follow-up diagnostic reassessment is still to be defined, in patients with myocarditis at different inflammatory stages, either with or without aetiology-dependent treatment.
5. Uniformly-designed studies are lacking, to compare myocarditis among different patient subgroups, differing by variables like: clinical presentations, myocarditis stage, associated cardiac or extra-cardiac diseases, aetiology-based treatment, associated arrhythmic manifestations, diagnostic workup, and devices or ablation treatment.

Detailed description: This study, previously designed as a single-center experience, is multicenter, observational and both retrospective and prospective.

Retrospective phase includes all clinical data occurring before the index event (hospitalization or clinically suspected myocarditis) and myocarditis diagnosis. Prospective phase includes all data following index event and myocarditis diagnosis.

This study has multiple aims.

1. To compare EMB with noninvasive diagnostic techniques (CMR, DECT, PET scan, either alone or in association).
2. To assess the role of blood biomarkers for identification of aetiology, predisposition, prognosis, response to treatment, inflammatory activity, clinical presentation.
3. To describe myocarditis presenting with arrhythmias, with special focus on ventricular arrhythmias at different myocarditis stages and in different clinical contexts. To validate and generalize the leader hospital model for optimal diagnostic and therapeutical management of arrhythmias in myocarditis patients (given the role of the leader hospital as an international referral center for arrhythmias ablation and management).
4. To evaluate the timing needed for myocarditis healing in different patients subgroups, as assessed by noninvasive imaging techniques (CMR, DECT, PET scan), either alone or in association.
5. To compare patients subgroups of myocarditis, in terms of epidemiology, aetiology, prognosis, and diagnostic-therapeutical strategies. Among the others, the main study subgroups will be:

A. Arrhythmic vs. non-arrhythmic myocarditis. B. Arrhythmic myocarditis subgroups. C. Non-arrhythmic myocarditis subgroups (i.e.: fulminant, acute coronary syndrome-like, pericarditis-like, heart failure, nonischaemic dilated /hypokinetic cardiomyopathies of unknown aetiology...).

D. Infectious vs. autoimmune vs. toxic myocarditis. E. Myocarditis treated by aetiology-based treatment vs. isolated cardiac medical treatment.

F. Myocarditis at different disease stages: acute, hyperacute, fulminant, chronic active, post-inflammatory, or active vs. previous vs. non-myocarditis.

G. Myocarditis presenting as organ-specific diseases vs. in the context of a genetic disorder or systemic disease.

H. Myocarditis vs. peri-myocarditis/myo-pericarditis. I. Other analyses.

Any adult patient with clinically suspected myocarditis, of any clinical presentation and any degree of severity, will be considered as suitable for study enrollment.

Patients will undergo diagnostic and therapeutical strategies considered as clinically indicated in a patient-tailored manner, as suggested by international guidelines recommendations and best local clinical practice. Patients will be free of either accepting or refusing any diagnostic or therapeutical proposal. Whenever accepted, data will be simply collected and analyzed.

Based on clinical presentation, patients will be divided into two groups, arrhythmic (group A) and non-arrhythmic (group NA, including any other clinical presentation).

Independently of A/NA groups, all patients will undergo optimal diagnostic and therapeutic strategies, as summarized in panel A. In parallel, special diagnostic and therapeutical strategies will be performed in patients with arrhythmic presentation or evidence of arrhythmias, as shown in panel B. Proposed flowcharts (Panels A and B) represent only an approximate algorithm. Exceptions can be made in single cases, based on clinical indications.

Panel A - Diagnostic and therapeutical workup in all patients. Independently of groups (A/NA), all patients will undergo optimal diagnostic and therapeutical workup, guided by updated scientific evidence merged with the clinical experience of the center.

Baseline diagnostic workup will include: complete blood exams, 12-leads ECG, continuous telemetric monitoring, transthoracic doppler echocardiogram, coronary artery imaging (coronary angiography or CT scan). Any other clinically relevant diagnostic test will be collected.

In life-threatening presentations (cardiogenic shock or malignant arrhythmias), support treatment by optimal medical therapy, inotropic or mechanical circulatory support, and acute-phase arrhythmia management (including cardioversion, defibrillation, or temporary pacing) will be performed, as indicated, before completing diagnostic workup.

Final diagnosis of myocarditis will include, whenever applicable:

A. For stable patients: 1) a second-level imaging technique (CMR as first choice; and/or DECT, PET, or multiple/fusion imaging techniques, based on clinical indications); followed by: 2) EMB, whenever clinically indicated. Blood exams for aetiology screening will be personalized upon clinical indications.

B. For unstable patients: EMB only, as recommended. Blood exams for aetiology screening will be personalized upon clinical indications.

Diagnostic criteria for myocarditis, as assessed by any diagnostic technique, will be defined based on international scientific evidence and will be constantly updated. Similar considerations apply to myocarditis staging and aetiology definition. Whenever not available at local institutions, diagnostic exams can be performed and analyzed at external centers.

All patients with myocarditis (or any alternative final diagnosis), will undergo standard cardiological optimal medical treatment (COMT), as indicated. By converse, aetiology-dependent treatment will be performed only in patients with a final diagnosis of any active (acute, fulminant, chronic active) myocarditis of defined aetiology (EMB-proved). Multidisciplinary assessment, including infective disease specialists (in viral/infective myocarditis), immunologists (in non-infective/autoimmune myocarditis) or any other specialist as needed, will be used to identify indications to treatment, drug choice (either approved or with a justified unapproved indication), treatment duration and safety profile, aiming at the best patients' interest. Toxic myocarditis will be treated accordingly, by evaluating the opportunity of withdrawing pathogenic noxa.

This protocol will not interfere with local best clinical practice. Patients with non-active myocarditis (previous or healed) or with non-myocarditis, will undergo "standard FU" (see below). Patients with active myocarditis will undergo "intensive FU" (see below).

Independently of FU modalities, diagnostic reassessment will be considered in the presence of at least one of the following instability criteria: a) new unexplained cardiac symptoms (dyspnoea, chest pain, syncope, palpitation); b) new unexplained increase in troponin or natriuretic peptides; c) new imaging abnormal signs; d) new unexplained clinically relevant arrhythmias. Diagnostic reassessment will include second-level imaging and/or EMB, as shown above. Subsequent therapeutical workup will be in line with the above explanations. In stable patients or undergone myocarditis healing, exercise stress test will be obtained, whenever possible.

Panel B - Diagnostic and therapeutical workup of patients with arrhythmias In parallel with (and independently of) Panel A content, patients with arrhythmias (group A) will undergo specific diagnostic and therapeutical management for arrhythmias, as a result of the integration between international guidelines recommendations and the experience of an international referral center for arrhythmia management and ablation.

To oversimplify, 4 groups of patients will be considered.

1. Group 1: major ventricular arrhythmias, including haemodynamically unstable VT (hu-VT) and ventricular fibrillation (VF).

   After electrical stabilization and support treatment (panel A), indication to secondary prevention ICD implant will be multiparametric and patient-tailored. In patients with active myocarditis, subcutaneous ICD (S-ICD) or wearable CD (WCD) will be considered. Antiarrhythmic drugs will be considered in all Group 1 patients. In addition, all Group 1 patients will undergo COMT and aetiology-dependent treatment whenever applicable (panel A). Ablation of ventricular arrhythmias will be considered in patients with severe arrhythmic presentation, or symptomatic, or refractory to optimal medical treatment. Electrophysiological study (EPS) may be used in selected cases. A cardiac resynchronization therapy with defibrillator function (CRT-D) will replace ICD whenever indicated.
2. Group 2: other ventricular arrhythmias, including high-burden (hb) premature ventricular complexes (PVC); nonsustained VT (NSVT); haemodynamically stable VT (hs-VT).

   Whenever clinically indicated, Group 2 patients will undergo invasive EPS (or in alternative noninvasive programmed ventricular stimulation in ICD carriers) to stratify arrhythmic risk. Patients with positive EPS will undergo ICD (or S-ICD/WCD) as in Group 1. Patients with negative EPS, as well as Group 2 cases not undergoing EPS, will undergo watchful waiting strategy (always with an intensive FU) with or without loop recorder implant: in these cases, ICD (or S-ICD/WCD) will be implanted only following documentation of relevant VA in FU. In addition, all Group 2 patients will undergo antiarrhythmic treatment, COMT and aetiology-dependent treatment whenever applicable (panel A). In symptomatic or drug-refractory cases, ablation of ventricular arrhythmias will be considered. A CRT-D will replace ICD whenever indicated.
3. Group 3: bradyarrhythmias, including advanced (2nd type II or 3rd degree) atrioventricular block (AVB); critical sinus pauses from sinus node disease (SND).

   After electrical stabilization and support treatment (panel A), including the use of temporary pacemaker as a bridge-to-decision, patients will undergo watchful waiting strategy or definitive device implant. Instead of a pacemaker (PM), ICD will be considered in the presence of high-risk criteria for ventricular tachyarrhythmias, including: a) overlap with Group 1 presentation; b) overlap with Group 2 presentation, especially in the presence of positive EPS; c) other indications for primary prevention ICD implant (severe systolic dysfunction); d) signs of increased tachyarrhythmic risk (scar signs); e) patients with special aetiologies leading to an increased tachyarrhythmic risk (i.e: cardiac sarcoid, giant cell myocarditis, Chagas disease, overlapping genetic syndromes). In addition, all Group 3 patients will undergo COMT and aetiology-dependent treatment whenever applicable (panel A). A CRT-D or a CRT-P will replace ICD or PM, respectively, whenever indicated.
4. Group 4: supraventricular arrhythmias, including atrial fibrillation (AF); atrial flutter (AFlu); atrial tachycardia (AT).

   Following acute-phase rate control (RaC), stable rhythm control (RyC) strategy will be considered as the therapeutical target, together with appropriate anticoagulation, as needed. Normal sinus rhythm will be obtained through either electrical or pharmacological cardioversion. In patients with unsuccessful attempts of sinus rhythm conversion, optimal treatment of active myocarditis will be considered as a primary target. Following myocarditis healing, in the presence of persistent arrhythmias, patients will be considered for RyC via electrical or pharmacological cardioversion. Transcatheter ablation will be an option for patients with drug-symptomatic, recurrent or refractory arrhythmias. Permanent RaC strategy will be considered only in non responders. Widespread use of implantable loop recorders will apply, as clinically indicated. In addition, all Group 4 patients will undergo COMT and aetiology-dependent treatment whenever applicable (panel A).

   Aims in detail. Aim 1 Comparison between EMB and second level imaging findings (N=1000)

   Primary:

   Diagnostic concordance

   Secondary:

   Inflammatory activity (presence; type; quantification) Fibrosis (presence; type; quantification) Coronary microvascular disease Comparison between EMB sampling site and abnormal substrate localization at imaging (including substrate-guided EMB or alternative biopsy techniques) Role of EMB guided by electroanatomical map Diagnostic performance of DECT and/or PET, especially when CMR is contraindicated Comparison between CMR/DECT findings and PET scan (including fusion imaging) or advanced imaging techniques including strain analysis at echocardiogram Comparison between substrate abnormalities localizations (as assessed by second level imaging techniques) and arrhythmias (type, characteristics and origin site) Comparison among different diagnostic techniques (EMB, CMR/DECT, PET) in terms of safety and diagnostic accuracy Evaluation of differential diagnosis with other cardias diseases, and particularly with arrhythmogenic cardiomyopathy of any localization (left, right, biventricular, to identify updated diagnostic criteria) Comparison between information provided by all the techniques above, and data from electroanatomical mapping (EAM) Other analyses

   Aim 2 Evaluation of blood exams and biomarkers (N=1000)

   Primary:

   Identification of diagnostic biomarkers Identification of aetiology biomarkers

   Secondary:

   Cardiac and inflammatory biomarkers evaluation in different myocarditis subtypes Identification of biomarkers of inflammatory stage (acute vs. chronic; active vs. previous) Comparison between local and systemic/peripheral inflammation Correlations with EMB and second-level imaging (CMR, DECT, PET...) findings Identification of genetic factors with any role in predisposition, prognosis, response to treatment, or any other correlation, either in the presence or in the absence of underlying cardiomyopathy or autoimmune/inflammatory disease Identification of prognostic biomarkers Identification of biomarkers associated with treatment response Evaluation of any tissue/organ damage or associated comorbidities Study of cardiac autoantibodies Study of any cell, tissue, genetic or circulating biomarker Correlations with clinical presentations Other analyses

   Aim 3 Validation of optimal management of arrhythmic myocarditis (N=1000)

   Primary:

   Evaluation of effects on major endpoints

   Secondary:

   Evaluation of effects on minor endpoints Role of electrophysiological study in risk stratification Role of loop recorders in arrhythmia monitoring Role of transcatheter ablation (any technique) on arrhythmic outcomes Identification of optimal timing for any electrophysiological/device procedure Role of pharmacological antiarrhythmic treatment Role of aetiology-specific treatment on arrhythmic outcomes Identification of criteria for device implants (PM, ICD, S-ICD, CRT-D...) in myocarditis patients Validation of therapeutic strategies and their optimal timing in patients with supraventricular arrhythmias, bradyarrhythmias, or ventricular arrhythmias Correlation between arrhythmia type/features with any other diagnostic exam performed at baseline or during FU (mainly EMB, CMR/DECT/PET, echocardiogram, stress tests, blood exams, genetic/blood/tissue/cell biomarkers) Indications and timing for device (ICD, CRT-D) implant in primary prevention, based on multiparametric risk assessment, and in relation to different general and aetiology-dependent treatments Other analyses

   Aim 4 Evaluation of healing timing in myocarditis (N=500) Primary Any degree of recovery by 3, 6, 9, 12 and \> 12 months Secondary Comparison of healing times in treated vs. untreated patients Correlations between healing times and clinical presentation types Correlations between healing times and any biomarker Correlations between healing times and any outcomes Validation of exercise stress test role after myocarditis healing Evaluation of PET scan or other diagnostic techniques as alternatives to CMR in special populations Other analyses

   Aim 5 Subgroup analyses (N=500, hugely variable in each subanalysis) A vs. NA groups; A myocarditis subgroups; NA myocarditis subgroups (including fulminant); Infective vs. autoimmune vs. toxic forms; Treated by aetiology-driven therapy vs. standard cardiological treatment; Different myocarditis stages and differential diagnoses; Isolated vs. in the context o a systemic disease or genetic disease; Myocarditis vs. perimyocarditis/ myopericarditis Primary Differences in major outcomes Secondary Differences in minor outcomes Differences in any biomarker Differences in any diagnostic exam Differences in aetiology Differences in predisposition Differences in inflammatory activity Differences in pericardial involvement Differences in systemic involvement Differences in arrhythmias types and features Differences in clinical presentation Differences in treatment response, including novel treatments Validation of local aetiology/pathophysiology-dependent treatments Validation of biomarkers and imaging techniques in monitoring response to treatment Identification of optimal follow-up timeline Other analyses

Eligibility criteria: Inclusion Criteria:

* Written informed consent.
* Age ≥ 18 years.
* Clinically suspected myocarditis.
* Enrollment performed by one of the participating Centers.

Exclusion Criteria:

* Absence of written informed consent.
* Age \< 18 years (paediatric population).

Primary outcomes:
measure: Occurrence of major cardiac events
timeFrame: By 12-month follow-up
measure: Occurrence of major cardiac events
timeFrame: By 24-month follow-up
measure: Occurrence of major cardiac events
timeFrame: By 3-year follow-up
measure: Occurrence of major cardiac events
timeFrame: By 5-year follow-up
measure: Occurrence of major cardiac events
timeFrame: By 7-year follow-up
measure: Occurrence of major cardiac events
timeFrame: By 10-year follow-up
measure: Assessment of diagnostic accuracy (in terms of true/false positive/negative rates) between EMB and second level imaging findings - Primary
timeFrame: At baseline assessment
measure: Assessment of diagnostic accuracy (in terms of true/false positive/negative rates) between EMB and second level imaging findings - Primary
timeFrame: By 6-month follow-up
measure: Assessment of diagnostic accuracy (in terms of true/false positive/negative rates) between EMB and second level imaging findings - Primary
timeFrame: By 12-month follow-up
measure: Assessment of diagnostic accuracy (in terms of true/false positive/negative rates) between EMB and second level imaging findings - Primary
timeFrame: By 24-month follow-up
measure: Assessment of diagnostic accuracy (in terms of true/false positive/negative rates) between EMB and second level imaging findings - Primary
timeFrame: By 3-year follow-up
measure: Assessment of diagnostic accuracy (in terms of true/false positive/negative rates) between EMB and second level imaging findings - Primary
timeFrame: By 5-year follow-up
measure: Assessment of diagnostic accuracy (in terms of true/false positive/negative rates) between EMB and second level imaging findings - Primary
timeFrame: By 10-year follow-up
measure: Comparison of troponin values in patients with different aetiologies
timeFrame: At baseline assessment
measure: Description of troponin values changes during follow-up
timeFrame: By 10-year follow-up
measure: Comparison of creatine-phosphokinase values in patients with different aetiologies
timeFrame: At baseline assessment
measure: Description of creatine-phosphokinase values changes during follow-up
timeFrame: By 10-year follow-up
measure: Comparison of natriuretic peptides values in patients with different aetiologies
timeFrame: At baseline assessment
measure: Description of natriuretic peptides values changes during follow-up
timeFrame: By 10-year follow-up
measure: Comparison of C-reactive protein values in patients with different aetiologies
timeFrame: At baseline assessment
measure: Description of C-reactive protein values changes during follow-up
timeFrame: By 10-year follow-up
measure: Comparison of erythrocyte sedimentation rate values in patients with different aetiologies
timeFrame: At baseline assessment
measure: Description of erythrocyte sedimentation rate values changes during follow-up
timeFrame: By 10-year follow-up
measure: Comparison of procalcitonin values in patients with different aetiologies
timeFrame: At baseline assessment
measure: Comparison of procalcitonin values in patients with different aetiologies
timeFrame: By 10-year follow-up
measure: Comparison of serum uric acid values in patients with different aetiologies
timeFrame: At baseline assessment
measure: Comparison of serum uric acid values in patients with different aetiologies
timeFrame: By 10-year follow-up
measure: Comparison of leukocyte values in patients with different aetiologies
timeFrame: At baseline assessment
measure: Comparison of leukocyte values in patients with different aetiologies
timeFrame: By 10-year follow-up
measure: Comparison of hemoglobin values in patients with different aetiologies
timeFrame: At baseline assessment
measure: Comparison of hemoglobin values in patients with different aetiologies
timeFrame: By 10-year follow-up
measure: Comparison of platelet values in patients with different aetiologies
timeFrame: At baseline assessment
measure: Comparison of platelet values in patients with different aetiologies
timeFrame: By 10-year follow-up
measure: Comparison of thyroid function in patients with different aetiologies
timeFrame: At baseline assessment
measure: Comparison of thyroid function in patients with different aetiologies
timeFrame: By 10-year follow-up
measure: Comparison of organ damage in patients with different aetiologies
timeFrame: At baseline assessment
measure: Comparison of organ damage in patients with different aetiologies
timeFrame: By 10-year follow-up
measure: Reporting the results of autoimmunity screening
timeFrame: At baseline assessment
measure: Reporting the results of autoimmunity screening
timeFrame: By 10-year follow-up
measure: Reporting the results of infectious screening
timeFrame: At baseline assessment
measure: Reporting the results of infectious screening
timeFrame: By 10-year follow-up
measure: Reporting the results of toxicology screening
timeFrame: At baseline assessment
measure: Reporting the results of toxicology screening
timeFrame: By 10-year follow-up
measure: Reporting the results of genetic test screening
timeFrame: At baseline assessment
measure: Reporting the results of genetic test screening
timeFrame: By 10-year follow-up
measure: Validation of optimal management of arrhythmic myocarditis by comparing the occurrence of major cardiac events in patients undergoing different therapeutic strategies - Primary
timeFrame: By 10-year follow-up
measure: Validation of optimal management of arrhythmic myocarditis by comparing the occurrence of major cardiac events in patients undergoing different therapeutic strategies - Primary
timeFrame: By 12-month follow-up
measure: Validation of optimal management of arrhythmic myocarditis by comparing the occurrence of major cardiac events in patients undergoing different therapeutic strategies - Primary
timeFrame: By 24-month follow-up
measure: Validation of optimal management of arrhythmic myocarditis by comparing the occurrence of major cardiac events in patients undergoing different therapeutic strategies - Primary
timeFrame: By 3-year follow-up
measure: Validation of optimal management of arrhythmic myocarditis by comparing the occurrence of major cardiac events in patients undergoing different therapeutic strategies - Primary
timeFrame: By 5-year follow-up
measure: Validation of optimal management of arrhythmic myocarditis by comparing the occurrence of major cardiac events in patients undergoing different therapeutic strategies - Primary
timeFrame: By 7-year follow-up
measure: Evaluation of healing timing in myocarditis - Primary
timeFrame: By 1-month follow-up
measure: Evaluation of healing timing in myocarditis - Primary
timeFrame: By 3-month follow-up
measure: Evaluation of healing timing in myocarditis - Primary
timeFrame: By 6-month follow-up
measure: Evaluation of healing timing in myocarditis - Primary
timeFrame: By 9-month follow-up
measure: Evaluation of healing timing in myocarditis - Primary
timeFrame: By 12-month follow-up
measure: Evaluation of healing timing in myocarditis - Primary
timeFrame: By 18-month follow-up
measure: Evaluation of healing timing in myocarditis - Primary
timeFrame: By 24-month follow-up
measure: Evaluation of healing timing in myocarditis - Primary
timeFrame: By 3-year follow-up
measure: Evaluation of healing timing in myocarditis - Primary
timeFrame: By 5-year follow-up
measure: Evaluation of healing timing in myocarditis - Primary
timeFrame: By 7-year follow-up
measure: Evaluation of healing timing in myocarditis - Primary
timeFrame: By 10-year follow-up
measure: Comparison of the incidence of major cardiac events in different patient subgroups - Primary
timeFrame: At baseline assessment
measure: Comparison of the incidence of major cardiac events in different patient subgroups - Primary
timeFrame: By 12-month follow-up
measure: Comparison of the incidence of major cardiac events in different patient subgroups - Primary
timeFrame: By 24-month follow-up
measure: Comparison of the incidence of major cardiac events in different patient subgroups - Primary
timeFrame: By 3-year follow-up
measure: Comparison of the incidence of major cardiac events in different patient subgroups - Primary
timeFrame: By 5-year follow-up
measure: Comparison of the incidence of major cardiac events in different patient subgroups - Primary
timeFrame: By 7-year follow-up
measure: Comparison of the incidence of major cardiac events in different patient subgroups - Primary
timeFrame: By 10-year follow-up
Secondary outcomes:
measure: Occurrence of minor arrhythmic events
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Any modification in imaging parameters
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Any modification in clinical parameters
timeFrame: By 10-year follow-up
measure: Any modification in New York Heart Association class
timeFrame: By 10-year follow-up
measure: Any modification in exercise peak heart rate
timeFrame: By 10-year follow-up
measure: Any modification in exercise peak systolic blood pressure
timeFrame: By 10-year follow-up
measure: Any modification in exercise walking distance
timeFrame: By 10-year follow-up
measure: Any modification in exercise oxygen consumption
timeFrame: By 10-year follow-up
measure: Any modification in exercise-induced arrhythmias
timeFrame: By 10-year follow-up
measure: Identification of the prevalence of associated diseases
timeFrame: By 10-year follow-up
measure: Any modification in arrhythmia burden
timeFrame: By 10-year follow-up
measure: Any modification in arrhythmia morphology
timeFrame: By 10-year follow-up
measure: Any modification in arrhythmia regularity
timeFrame: By 10-year follow-up
measure: Any modification in arrhythmia tolerance
timeFrame: By 10-year follow-up
measure: Prevalence of coronary circulation abnormalities
timeFrame: By 10-year follow-up
measure: Prevalence of electrophysiological study
timeFrame: By 10-year follow-up
measure: Results of electrophysiological study
timeFrame: By 10-year follow-up
measure: Prevalence of ventricular arrhythmia ablation
timeFrame: By 10-year follow-up
measure: Results of ventricular arrhythmia ablation
timeFrame: By 10-year follow-up
measure: Prevalence of supraventricular arrhythmia ablation
timeFrame: By 10-year follow-up
measure: Results of supraventricular arrhythmia ablation
timeFrame: By 10-year follow-up
measure: Prevalence of cardiac device implants
timeFrame: By 10-year follow-up
measure: Comparison of arrhythmia detection by continuous vs. non-continuous monitoring
timeFrame: By 10-year follow-up
measure: Assessment of the withdrawal timing of non-permanent cardiac devices
timeFrame: By 10-year follow-up
measure: Prevalence of CT scan
timeFrame: By 10-year follow-up
measure: Results of CT scan
timeFrame: By 10-year follow-up
measure: Prevalence of PET scan
timeFrame: By 10-year follow-up
measure: Results of PET scan
timeFrame: By 10-year follow-up
measure: Prevalence of electroanatomical mapping
timeFrame: By 10-year follow-up
measure: Results of electroanatomical mapping
timeFrame: By 10-year follow-up
measure: Prevalence of stress tests
timeFrame: By 10-year follow-up
measure: Results of stress tests - ECG
timeFrame: By 10-year follow-up
measure: Results of stress tests - wall motion abnormalities
timeFrame: By 10-year follow-up
measure: Results of stress tests - coronary flow reserve
timeFrame: By 10-year follow-up
measure: Myocarditis recurrences
timeFrame: At baseline assessment (including past medical history) and through study completion (up to 10 years)
measure: Response to treatment - systolic function
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Response to treatment - malignant ventricular arrhythmias
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Prognostic risk stratification - malignant ventricular arrhythmias
timeFrame: Through study completion (up to 10 years)
measure: Prognostic risk stratification - heart failure
timeFrame: Through study completion (up to 10 years)
measure: Prognostic risk stratification - cardiac death
timeFrame: Through study completion (up to 10 years)
measure: Description of multidisciplinary workup models
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Prognostic impact of multidisciplinary workup models
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison between EMB and second level imaging findings in detecting myocardial inflammation
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison between EMB and second level imaging findings in detecting myocardial fibrosis
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison between EMB and second level imaging findings in detecting coronary microvascular disease
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison between EMB sampling site and abnormal substrate localization at imaging
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison between substrate-guided vs. standard EMB sampling. Substrate defined by any second level imaging technique (CMR, PET, DECT, electroanatomical mapping). EMB sampling performed at any cardiac site.
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison between different second level imaging findings
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Associations between arrhythmia morphology and substrate localization
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Associations between arrhythmia morphology and inflammatory stage
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Associations between arrhythmia regularity and inflammatory stage
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Prevalence of adverse effects associated with EMB
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Prevalence of adverse effects associated with immunosuppressive therapy
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Prevalence of overlap syndromes and differential diagnoses
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison between histology abnormalities and arrhythmias
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison between genetic test results and myocarditis features
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Corrrelation between troponin abnormalities and follow-up occurrence of malignant ventricular arrhythmias
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Corrrelation between troponin abnormalities and follow-up occurrence of heart failure
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Corrrelation between NTproBNP abnormalities and follow-up occurrence of malignant ventricular arrhythmias
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Corrrelation between NTproBNP abnormalities and follow-up occurrence of heart failure
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Corrrelation between C-reactive protein abnormalities and follow-up occurrence of malignant ventricular arrhythmias
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Corrrelation between C-reactive protein abnormalities and follow-up occurrence of heart failure
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Corrrelation between histological abnormalities and follow-up occurrence of malignant ventricular arrhythmias
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Corrrelation between histological abnormalities and follow-up occurrence of heart failure
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of minor arrhythmic events in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of left ventricular end-diastolic volume in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of right ventricular end-diastolic volume in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of left ventricular ejection fraction in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of right ventricular ejection fraction in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of biventricular global longitudinal strain in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of left atrial volume in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of left ventricular diastolic dysfunction in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of pericardial abnormalities in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of valvular abnormalities in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of CMR abnormalities in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of DECT abnormalities in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of PET abnormalities in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of electroanatomical mapping abnormalities in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of symptoms in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of exercise tolerance in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of troponin in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of NTproBNP in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of C-reactive protein in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of arrhythmia burden in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of arrhythmia morphology in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of arrhythmia regularity in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of arrhythmia tolerance in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Evaluation of myocarditis healing time in patients undergoing different therapeutic strategies
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of the incidence of minor arrhythmic events in different patient subgroups
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of left ventricular ejection fraction in different patient subgroups
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of CMR abnormalities in different patient subgroups
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of DECT abnormalities in different patient subgroups
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of PET abnormalities in different patient subgroups
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of electroanatomical abnormalities in different patient subgroups
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of troponin abnormalities in different patient subgroups
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of NTproBNP abnormalities in different patient subgroups
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of C-reactive protein abnormalities in different patient subgroups
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of autoantibodies abnormalities in different patient subgroups
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of genetic test abnormalities in different patient subgroups
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of histological abnormalities in different patient subgroups
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of exercise tolerance in different patient subgroups
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of arrhythmia burden in different patient subgroups
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of arrhythmia morphology in different patient subgroups
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of arrhythmia regularity in different patient subgroups
timeFrame: At baseline assessment and through study completion (up to 10 years)
measure: Comparison of myocarditis healing time in different patient subgroups
timeFrame: At baseline assessment and through study completion (up to 10 years)
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Scientific Institute
state: Milano
Study officials:
affiliation: San Raffaele Scientific Institute, Milan, Italy
name: Paolo Della Bella, MD
role: STUDY_CHAIR
References:
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citation: Peretto G, Cappelletti AM, Spoladore R, Slavich M, Rizzo S, Palmisano A, Esposito A, De Cobelli F, Margonato A, Basso C, Della Bella P, Sala S. Right ventricular endomyocardial biopsy in patients with cardiac magnetic resonance showing left ventricular myocarditis. J Cardiovasc Med (Hagerstown). 2021 Jul 1;22(7):560-566. doi: 10.2459/JCM.0000000000001162.
citation: Peretto G, Villatore A, Rizzo S, Esposito A, De Luca G, Palmisano A, Vignale D, Cappelletti AM, Tresoldi M, Campochiaro C, Sartorelli S, Ripa M, De Gaspari M, Busnardo E, Ferro P, Calabro MG, Fominskiy E, Monaco F, Cavalli G, Gianolli L, De Cobelli F, Margonato A, Dagna L, Scandroglio M, Camici PG, Mazzone P, Della Bella P, Basso C, Sala S. The Spectrum of COVID-19-Associated Myocarditis: A Patient-Tailored Multidisciplinary Approach. J Clin Med. 2021 May 4;10(9):1974. doi: 10.3390/jcm10091974.
citation: Peretto G, Sala S, Camaschella C. Iron deficiency in chronic myocarditis: Assessment and prognostic significance. Eur J Intern Med. 2021 Jul;89:129-131. doi: 10.1016/j.ejim.2021.03.037. Epub 2021 Apr 21. No abstract available.
citation: Peretto G, Barzaghi F, Cicalese MP, Di Resta C, Slavich M, Benedetti S, Giangiobbe S, Rizzo S, Palmisano A, Esposito A, De Cobelli F, Gulletta S, Basso C, Casari G, Aiuti A, Della Bella P, Sala S. Immunosuppressive therapy in childhood-onset arrhythmogenic inflammatory cardiomyopathy. Pacing Clin Electrophysiol. 2021 Mar;44(3):552-556. doi: 10.1111/pace.14153. Epub 2021 Jan 18.
citation: Cenciarelli S, Calbi V, Barzaghi F, Bernardo ME, Oltolini C, Migliavacca M, Gallo V, Tucci F, Fraschetta F, Albertazzi E, Fratini ES, Consiglieri G, Giannelli S, Dionisio F, Sartirana C, Racca S, Camesasca C, Peretto G, Daverio R, Esposito A, De Cobelli F, Silvani P, Rabusin M, Cara A, Trabattoni D, Dispinseri S, Scarlatti G, Piemonti L, Lampasona V, Cicalese MP, Aiuti A, Ferrua F. Mild SARS-CoV-2 Infection After Gene Therapy in a Child With Wiskott-Aldrich Syndrome: A Case Report. Front Immunol. 2020 Nov 24;11:603428. doi: 10.3389/fimmu.2020.603428. eCollection 2020.
citation: Peretto G, Sala S, De Luca G, Marcolongo R, Campochiaro C, Sartorelli S, Tresoldi M, Foppoli L, Palmisano A, Esposito A, De Cobelli F, Rizzo S, Thiene G, Basso C, Dagna L, Caforio ALP, Della Bella P. Immunosuppressive Therapy and Risk Stratification of Patients With Myocarditis Presenting With Ventricular Arrhythmias. JACC Clin Electrophysiol. 2020 Oct;6(10):1221-1234. doi: 10.1016/j.jacep.2020.05.013. Epub 2020 Jun 24.
citation: Peretto G, Sala S, Basso C, Rizzo S, Radinovic A, Frontera A, Limite LR, Paglino G, Bisceglia C, De Luca G, Campochiaro C, Sartorelli S, Palmisano A, Esposito A, Busnardo E, Villatore A, Baratto F, Cireddu M, Marzi A, D'Angelo G, Gulletta S, Vergara P, De Cobelli F, Dagna L, Mazzone P, Della Bella P. Inflammation as a Predictor of Recurrent Ventricular Tachycardia After Ablation in Patients With Myocarditis. J Am Coll Cardiol. 2020 Oct 6;76(14):1644-1656. doi: 10.1016/j.jacc.2020.08.012.
citation: Peretto G, De Luca G, Campochiaro C, Palmisano A, Busnardo E, Sartorelli S, Barzaghi F, Cicalese MP, Esposito A, Sala S. Telemedicine in myocarditis: Evolution of a mutidisciplinary "disease unit" at the time of COVID-19 pandemic. Am Heart J. 2020 Nov;229:121-126. doi: 10.1016/j.ahj.2020.07.015. Epub 2020 Aug 12.
citation: Peretto G, Sala S, Della Bella P, Basso C, Cooper LT Jr. Reply: Genetic Basis for Acute Myocarditis Presenting With Ventricular Arrhythmias? J Am Coll Cardiol. 2020 Jul 7;76(1):126-128. doi: 10.1016/j.jacc.2020.05.014. No abstract available.