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
NCT ID: NCT04521790
Last Updated: 2024-09-19
Study Results
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Basic Information
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RECRUITING
1000 participants
OBSERVATIONAL
2018-01-30
2035-12-31
Brief Summary
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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.
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Detailed Description
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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
Conditions
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Study Design
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CASE_CONTROL
OTHER
Study Groups
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Arrhythmic (A)
Arrhythmic Group. To oversimplify, specific subgroups of patients will be considered.
1. Group 1: major ventricular arrhythmias (haemodynamically unstable VT, hu-VT; ventricular fibrillation, VF).
2. Group 2: other ventricular arrhythmias (high-burden premature ventricular complexes = hb-PVC; nonsustained VT = NSVT; haemodynamically stable VT = hs-VT).
3. Group 3: bradyarrhythmias (2nd type II or 3rd degree atrioventricular block = advanced AVB; critical sinus pauses = SND).
4. Group 4: supraventricular arrhythmias (atrial fibrillation = AF; atrial flutter = AFlu; atrial tachycardia = AT).
support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation
Treatment will be patient-tailored, integrating international guidelines recommendation and the experience of the center where enrollment takes place.
Nonarrhythmic (NA)
Nonarrhythmic Group. To oversimplify, specific subgroups of patients will be considered.
1. Heart failure presentation (and subtypes)
2. Chest pain presentation (and subtypes)
3. Asymptomatic presentation/screening (and subtypes)
support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation
Treatment will be patient-tailored, integrating international guidelines recommendation and the experience of the center where enrollment takes place.
Subgroups
For specific study aims, different patient subgroups will be compared. The main groups are hereby reported:
A. Arrhythmic myocarditis subgroups (1-4). B. Non-arrhythmic myocarditis subgroups (i.e.: fulminant, acute coronary syndrome-like, pericarditis-like, heart failure, nonischaemic dilated /hypokinetic cardiomyopathies of unknown aetiology…).
C. Infectious vs. autoimmune vs. toxic myocarditis. D. Myocarditis treated by aetiology-based treatment vs. isolated cardiac medical treatment.
E. Myocarditis at different disease stages: acute, hyperacute, fulminant, chronic active, post-inflammatory, or active vs. previous vs. non-myocarditis.
F. Myocarditis presenting as organ-specific diseases vs. in the context of a genetic disorder or systemic disease.
G. Myocarditis vs. peri-myocarditis/myo-pericarditis. H. Other subgroups.
support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation
Treatment will be patient-tailored, integrating international guidelines recommendation and the experience of the center where enrollment takes place.
Interventions
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support treatment, cardiac medical treatment, aetiology-specific treatment, device implant, arrhythmia ablation
Treatment will be patient-tailored, integrating international guidelines recommendation and the experience of the center where enrollment takes place.
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years.
* Clinically suspected myocarditis.
* Enrollment performed by one of the participating Centers.
Exclusion Criteria
* Age \< 18 years (paediatric population).
18 Years
ALL
No
Sponsors
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Scientific Institute San Raffaele
OTHER
Responsible Party
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Giovanni Peretto
MD, Principal Investigator
Principal Investigators
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Paolo Della Bella, MD
Role: STUDY_CHAIR
San Raffaele Scientific Institute, Milan, Italy
Locations
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IRCCS San Raffaele Scientific Institute
Milan, Milano, Italy
Countries
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Central Contacts
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Facility Contacts
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References
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Ammirati E, Cipriani M, Moro C, Raineri C, Pini D, Sormani P, Mantovani R, Varrenti M, Pedrotti P, Conca C, Mafrici A, Grosu A, Briguglia D, Guglielmetto S, Perego GB, Colombo S, Caico SI, Giannattasio C, Maestroni A, Carubelli V, Metra M, Lombardi C, Campodonico J, Agostoni P, Peretto G, Scelsi L, Turco A, Di Tano G, Campana C, Belloni A, Morandi F, Mortara A, Ciro A, Senni M, Gavazzi A, Frigerio M, Oliva F, Camici PG; Registro Lombardo delle Miocarditi. Clinical Presentation and Outcome in a Contemporary Cohort of Patients With Acute Myocarditis: Multicenter Lombardy Registry. Circulation. 2018 Sep 11;138(11):1088-1099. doi: 10.1161/CIRCULATIONAHA.118.035319.
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Gatti M, Palmisano A, Faletti R, Benedetti G, Bergamasco L, Bioletto F, Peretto G, Sala S, De Cobelli F, Fonio P, Esposito A. Two-dimensional and three-dimensional cardiac magnetic resonance feature-tracking myocardial strain analysis in acute myocarditis patients with preserved ejection fraction. Int J Cardiovasc Imaging. 2019 Jun;35(6):1101-1109. doi: 10.1007/s10554-019-01588-8. Epub 2019 Mar 30.
De Luca G, Campochiaro C, Sartorelli S, Peretto G, Sala S, Palmisano A, Esposito A, Candela C, Basso C, Rizzo S, Thiene G, Della Bella P, Dagna L. Efficacy and safety of mycophenolate mofetil in patients with virus-negative lymphocytic myocarditis: A prospective cohort study. J Autoimmun. 2020 Jan;106:102330. doi: 10.1016/j.jaut.2019.102330. Epub 2019 Sep 3.
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Peretto G, Sala S, Basso C, Della Bella P. Programmed ventricular stimulation in patients with active vs previous arrhythmic myocarditis. J Cardiovasc Electrophysiol. 2020 Mar;31(3):692-701. doi: 10.1111/jce.14374. Epub 2020 Feb 3.
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Palmisano A, Vignale D, Peretto G, Busnardo E, Calcagno C, Campochiaro C, De Luca G, Sala S, Ferro P, Basso C, Del Maschio A, De Cobelli F, Esposito A. Hybrid FDG-PET/MR or FDG-PET/CT to Detect Disease Activity in Patients With Persisting Arrhythmias After Myocarditis. JACC Cardiovasc Imaging. 2021 Jan;14(1):288-292. doi: 10.1016/j.jcmg.2020.03.009. Epub 2020 Apr 15. No abstract available.
Peretto G, Casella M, Merlo M, Benedetti S, Rizzo S, Cappelletto C, Di Resta C, Compagnucci P, De Gaspari M, Dello Russo A, Casari G, Basso C, Sala S, Sinagra G, Della Bella P, Cooper LT Jr. Inflammation on Endomyocardial Biopsy Predicts Risk of MACE in Undefined Left Ventricular Arrhythmogenic Cardiomyopathy. JACC Clin Electrophysiol. 2023 Jul;9(7 Pt 1):951-961. doi: 10.1016/j.jacep.2022.10.032. Epub 2023 Jan 18.
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Peretto G, Gulletta S, Slavich M, Campochiaro C, Vignale D, De Luca G, Palmisano A, Villatore A, Rizzo S, Cavalli G, De Gaspari M, Busnardo E, Gianolli L, Dagna L, Basso C, Esposito A, Sala S, Della Bella P, Mazzone P. Exercise Stress Test Late after Arrhythmic versus Nonarrhythmic Presentation of Myocarditis. J Pers Med. 2022 Oct 12;12(10):1702. doi: 10.3390/jpm12101702.
Peretto G, Busnardo E, Ferro P, Palmisano A, Vignale D, Esposito A, De Luca G, Campochiaro C, Sartorelli S, De Gaspari M, Rizzo S, Dagna L, Basso C, Gianolli L, Della Bella P, Sala S. Clinical Applications of FDG-PET Scan in Arrhythmic Myocarditis. JACC Cardiovasc Imaging. 2022 Oct;15(10):1771-1780. doi: 10.1016/j.jcmg.2022.02.029. Epub 2022 May 11.
Ammirati E, Raimondi F, Piriou N, Sardo Infirri L, Mohiddin SA, Mazzanti A, Shenoy C, Cavallari UA, Imazio M, Aquaro GD, Olivotto I, Pedrotti P, Sekhri N, Van de Heyning CM, Broeckx G, Peretto G, Guttmann O, Dellegrottaglie S, Scatteia A, Gentile P, Merlo M, Goldberg RI, Reyentovich A, Sciamanna C, Klaassen S, Poller W, Trankle CR, Abbate A, Keren A, Horowitz-Cederboim S, Cadrin-Tourigny J, Tadros R, Annoni GA, Bonoldi E, Toquet C, Marteau L, Probst V, Trochu JN, Kissopoulou A, Grosu A, Kukavica D, Trancuccio A, Gil C, Tini G, Pedrazzini M, Torchio M, Sinagra G, Gimeno JR, Bernasconi D, Valsecchi MG, Klingel K, Adler ED, Camici PG, Cooper LT Jr. Acute Myocarditis Associated With Desmosomal Gene Variants. JACC Heart Fail. 2022 Oct;10(10):714-727. doi: 10.1016/j.jchf.2022.06.013. Epub 2022 Sep 7.
Ramirez GA, Batani V, Moroni L, De Luca G, Pizzetti G, Sala S, Peretto G, Campochiaro C, Della-Torre E, Bozzolo EP, Dagna L. Cardiac Safety of mRNA-Based Vaccines in Patients with Systemic Lupus Erythematosus and Lupus-like Disorders with a History of Myocarditis. Pathogens. 2022 Sep 1;11(9):1001. doi: 10.3390/pathogens11091001.
Peretto G, Merlo M, Gentile P, Porcari A, Palmisano A, Vignale D, Sormani P, Rizzo S, De Gaspari M, Basso C, Bella PD, Sala S, Ammirati E, Sinagra G, Esposito A, Pedrotti P. Cardiac magnetic resonance abnormalities in patients with acute myocarditis proven by septal endomyocardial biopsy. Clin Res Cardiol. 2023 Mar;112(3):392-400. doi: 10.1007/s00392-022-02103-1. Epub 2022 Sep 16.
Nowatzke J, Guedeney P, Palaskas N, Lehmann L, Ederhy S, Zhu H, Cautela J, Francis S, Courand PY, Deswal A, Ewer SM, Aras M, Arangalage D, Ghafourian K, Fenioux C, Finke D, Peretto G, Zaha V, Itzhaki Ben Zadok O, Tajiri K, Akhter N, Levenson J, Baldassarre L, Power J, Huang S, Collet JP, Moslehi J, Salem JE; International ICI-myocarditis registry contributors. Coronary artery disease and revascularization associated with immune checkpoint blocker myocarditis: Report from an international registry. Eur J Cancer. 2022 Dec;177:197-205. doi: 10.1016/j.ejca.2022.07.018. Epub 2022 Aug 24.
Villatore A, Sala S, Stella S, Vignale D, Busnardo E, Esposito A, Basso C, Della Bella P, Mazzone P, Peretto G. Autoimmune Myocarditis and Arrhythmogenic Mitral Valve Prolapse: An Unexpected Overlap Syndrome. J Cardiovasc Dev Dis. 2021 Nov 6;8(11):151. doi: 10.3390/jcdd8110151.
Campochiaro C, Tomelleri A, Farina N, Cavalli G, De Luca G, Palmisano A, Peretto G, Esposito A, Rizzo S, Basso C, Matucci-Cerinic M, Dagna L. Myocarditis as a manifestation of Erdheim-Chester Disease: successful use of anti- IL1 and BRAF inhibitor combination therapy. Scand J Rheumatol. 2022 May;51(3):243-245. doi: 10.1080/03009742.2021.1992846. Epub 2021 Nov 17. No abstract available.
Peretto G, Mazzone P, Paglino G, Marzi A, Tsitsinakis G, Rizzo S, Basso C, Della Bella P, Sala S. Continuous Electrical Monitoring in Patients with Arrhythmic Myocarditis: Insights from a Referral Center. J Clin Med. 2021 Nov 1;10(21):5142. doi: 10.3390/jcm10215142.
Campochiaro C, Farina N, Tomelleri A, Ferrara R, Lazzari C, De Luca G, Bulotta A, Signorelli D, Palmisano A, Vignale D, Peretto G, Sala S, Esposito A, Garassino M, Gregorc V, Dagna L. Tocilizumab for the treatment of immune-related adverse events: a systematic literature review and a multicentre case series. Eur J Intern Med. 2021 Nov;93:87-94. doi: 10.1016/j.ejim.2021.07.016. Epub 2021 Aug 12.
Gentile P, Merlo M, Peretto G, Ammirati E, Sala S, Della Bella P, Aquaro GD, Imazio M, Potena L, Campodonico J, Foa A, Raafs A, Hazebroek M, Brambatti M, Cercek AC, Nucifora G, Shrivastava S, Huang F, Schmidt M, Muser D, Van de Heyning CM, Van Craenenbroeck E, Aoki T, Sugimura K, Shimokawa H, Cannata A, Artico J, Porcari A, Colopi M, Perkan A, Bussani R, Barbati G, Garascia A, Cipriani M, Agostoni P, Pereira N, Heymans S, Adler ED, Camici PG, Frigerio M, Sinagra G. Post-discharge arrhythmic risk stratification of patients with acute myocarditis and life-threatening ventricular tachyarrhythmias. Eur J Heart Fail. 2021 Dec;23(12):2045-2054. doi: 10.1002/ejhf.2288. Epub 2021 Jul 21.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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Document Type: Study Protocol
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