[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"myocarditis-acute\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:myocarditis-acute":24},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,10,0,[8,40,67,96,120,145,174,205,227,252],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":25,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100645038","one-year-prognostic-impact-of-microcirculation-assessed-by-nh-imr-angio-in-patients-hospitalized-for-acute-myocarditis-100645038",false,"NCT07676201","One-year Prognostic Impact of Microcirculation Assessed by NH IMR Angio in Patients Hospitalized for Acute Myocarditis","MICROMYOC","Inclusion Criteria:\n\n* Male or female patients over the age of 18.\n* Patients hospitalized between June 2015 and July 2025.\n* Patients who presented with chest pain and at least 1 diagnostic criterion; or, in the absence of chest pain, at least 2 of the following diagnostic criteria:\n\n  * Electrocardiographic abnormalities (ST-segment elevation or depression, T-wave inversions, conduction disturbances such as type 3 atrioventricular block),\n  * Elevated troponin levels,\n  * Abnormal kinematics on echocardiography.\n* Associated with MRI findings of ≥2 tissue abnormalities (edema, hyperemia, myocardial fibrosis).\n* Coronary angiography performed during the initial hospitalization\n* Patient enrolled in or eligible for a social security program.\n* Patient who has expressed consent to participate.\n\nExclusion Criteria:\n\n* Absence of coronary artery disease confirmed by coronary angiography\n* Myocarditis secondary to immunotherapy\n* Presence of documented coronary artery disease (coronary angiography or cardiac CT)\n* Presence of cardiomyopathy (hypertrophic cardiomyopathy, dilated cardiomyopathy)\n* Infiltrative heart disease (sarcoidosis or cardiac amyloidosis)\n* Severe valvular heart disease\n* Takotsubo syndrome\n* Constrictive or chronic pericarditis\n* Loeffler's endocarditis\n* Left ventricular noncompaction\n* Cardiac tumor\n* Pulmonary embolism\n* Coronary spasm\n* Patients covered by Articles L1121-5 through L1121-8 of the Public Health Code (pregnant women, women in labor, and breastfeeding women; persons deprived of their liberty by judicial or administrative decision; adults under guardianship)","ALL","18 Years",{"count":19,"type":20},106,"ESTIMATED","OBSERVATIONAL","The goal of this observational study is to evaluate the association between post-coronary angiography IMR and medium-term clinical prognosis in patients with acute myocarditis. The main question it aims to answer is:\n\nIs there a correlation between impaired microcirculation and the occurrence of serious clinical events in this population of patients?",[24],"Myocarditis Acute",[26,27],"NH IMR","Coronary catheterization","NOT_YET_RECRUITING","2026-06-23",{"date":31,"type":32},"2026-06-30","ACTUAL",{"date":34,"type":20},"2026-07-15",{"date":36,"type":20},"2026-10-15",{"name":38,"class":39},"University Hospital, Grenoble","OTHER",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":50,"conditions":51,"keywords":53,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":58,"lastUpdatePostDateStruct":59,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":4},"100631499","arrhythmic-risk-in-myocarditis-outcome-research-100631499","NCT07501481","Arrhythmic Risk in Myocarditis Outcome Research","Incidence, Clinical Impact, and Prediction of Ventricular Arrhythmia in Patients With Acute Myocarditis","ARMOR","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Hospitalization for acute myocarditis\n* Confirmation of the diagnosis of AM by at least one of the following: (1) Cardiac magnetic resonance according to the revised 2018 Lake Louise Criteria; (2) Endomyocardial biopsy according to the Dallas criteria with associated immunohistochemical and molecular criteria; (3) Cardiac computed tomography with compatible late iodine enhancement\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years\n* Concomitant acute coronary syndrome",{"count":49,"type":20},1500,"The goal of this observational, retrospective, multicenter study is to characterize the arrhythmic burden and identify predictive factors for ventricular arrhythmias (VAs) in adult patients hospitalized for acute myocarditis (AM). The main questions it aims to answer are:\n\n* What is the incidence of sustained ventricular arrhythmias during the index hospitalization in patients with acute myocarditis?\n* What clinical, biological, electrocardiographic, and imaging factors predict the occurrence of sustained ventricular arrhythmias during hospitalization and after discharge?\n\nResearchers will compare patients who developed sustained VAs during hospitalization to those who did not, in order to identify independent predictors of arrhythmic events and develop a validated risk stratification score.\n\nParticipants' medical records from 2020 to 2024 will be reviewed to collect:\n\n* Baseline demographic, clinical, biological, electrocardiographic, and imaging data at admission\n* In-hospital management strategies and outcomes, including mortality, cardiogenic shock, and heart replacement therapy\n* Long-term follow-up data including VA recurrence, sudden cardiac death, and development of cardiomyopathy, with censoring applied on January 1, 2026",[24,52],"Ventricular Arrhythmia",[54,55,56,57],"acute myocarditis","ventricular arrhythmia","ventricular tachycardia","ventricular fibrillation","2026-03-26",{"date":60,"type":32},"2026-03-30",{"date":62,"type":20},"2026-03-01",{"date":64,"type":20},"2027-03-31",{"name":66,"class":39},"AZ Sint-Jan AV",{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":82,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":95},"100568871","phase-3-non-steroidal-anti-inflammatory-drugs-in-acute-myocarditis-100568871","NCT06686862","Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis","Non-Steroidal Anti-Inflammatory Drugs Versus Conventional Treatment in Acute Myocarditis (INFLAMA Trial)","INFLAMA","Inclusion Criteria:\n\n* Aged 18 years or older.\n* Patients hospitalized for confirmed acute myocarditis and left ventricular ejection fraction ventricular \\>50%.\n* Elevated troponin I\u002FT (3 times above the upper limit of normal).\n* Absence of acute heart failure.\n* Absence of ischemic heart disease (ruled out by coronary angiography or coronary CT in individuals over 40 years).\n* Diagnostic criteria for myocarditis (Lake Louise, 2018 update) by cardiac magnetic resonance imaging.\n\nExclusion Criteria:\n\n* Kidney disease stage 3b, 4 and 5 (creatinine clearance by CKD-EPI \\\u003C45 ml\u002Fmin\u002F1.73 m2).\n* Severe liver failure (Child-Pugh class C).\n* Poorly controlled pharmacological hypertension (repeatedly systolic arterial pressure \\>140 mmHg).\n* Diagnosis criteria for acute pericarditis.\n* Moderate or severe pericardial effusion (\\>10 mm in total).\n* Hypersensitivity to NSAIDs or previous use in the last 7 days.\n* Contraindication for MRI.\n* Participation in another clinical trial.\n* Pregnancy, breastfeeding, or women of childbearing age unwilling to use appropriate contraception throughout the study.\n* Any circumstance that, in the investigator's opinion, compromises participation in the clinical trial.",{"count":76,"type":20},150,"INTERVENTIONAL",[79],"PHASE3","Prospective, randomized, multicenter, open-label clinical trial to evaluate the safety and efficacy of a 3-week ibuprofen tapering regimen compared to conventional analgesic treatment (acetaminophen) in patients with acute myocarditis and left ventricular ejection fraction ≥50%. The objective is to assess the reduction in late gadolinium enhancement on cardiac magnetic resonance imaging at 6-month follow-up.",[24],[83,84],"Nonsteroidal antiinflammatory agents","Magnetic Resonance Imaging","RECRUITING","2026-02-12",{"date":88,"type":32},"2026-02-13",{"date":90,"type":32},"2025-04-28",{"date":92,"type":20},"2027-10",{"name":94,"class":39},"Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III",1,{"id":97,"slug":98,"hasResults":11,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":104,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":106,"conditions":107,"keywords":108,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":114,"completionDateStruct":116,"leadSponsor":118,"locationsCount":4},"100623277","french-registry-of-cmr-late-gadolinium-enhancement-in-myocarditis-100623277","NCT07394543","French Registry of CMR Late Gadolinium Enhancement in Myocarditis","Retrospective French Registry of Cardiovascular Magnetic Resonance Late Gadolinium Enhancement in Patients With Myocarditis","MYOCARDITI-LGE","Inclusion Criteria:\n\n1. Age ≥ 18 years\n2. Ability to provide informed non-opposition\n3. AM diagnosis confirmed using CMR, fulfilling the modified Lake Louise diagnostic criteria\n\nExclusion Criteria:\n\n1\\. Patients unable to provide informed non-opposition.",{"count":105,"type":20},5000,"Acute myocarditis is a major cause of death in young adults and carries substantial morbidity, including a significant risk of progression to dilated cardiomyopathy. Current diagnostic and therapeutic strategies remain poorly defined, making risk stratification crucial to enable personalized treatments and reduce mortality and major cardiovascular events.",[24],[109,110],"Late Gadolinium Enhancement","Myocarditis","2026-01-30",{"date":113,"type":32},"2026-02-06",{"date":115,"type":20},"2026-02-10",{"date":117,"type":20},"2036-02-10",{"name":119,"class":39},"Assistance Publique - Hôpitaux de Paris",{"id":121,"slug":122,"hasResults":11,"nctId":123,"briefTitle":124,"officialTitle":125,"acronym":126,"eligibilityCriteria":127,"healthyVolunteers":11,"sex":16,"minAge":128,"maxAge":17,"enrollmentInfo":129,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":131,"conditions":132,"keywords":133,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":4},"100606468","outcome-of-clinical-phenotypes-of-pediatric-myocarditis-at-assiut-university-children-hospital-100606468","NCT07175948","Outcome of Clinical Phenotypes of Pediatric Myocarditis at Assiut University Children Hospital","Outcome of Different Clinical Phenotypes of Myocarditis in Children Admitted to Assiut University Children Hospital","PED-MYO","Inclusion Criteria:\n\n* • Children aged between 1 to 18 years.\n\n  * Children diagnosed with myocarditis based on clinical presentation, echocardiography, and cardiac biomarkers, ECG and MRI (if available)\n\nExclusion Criteria:\n\n* • Children with congenital heart disease.\n\n  * Known cardiomyopathy unrelated to myocarditis.","1 Year",{"count":130,"type":20},100,"This study aims to investigate the clinical phenotypes, management approaches, and outcomes of myocarditis in children admitted to Assiut University Children's Hospital. Myocarditis is an inflammatory disease of the heart muscle that can present in different clinical forms, including acute, fulminant, chronic active, and chronic persistent types. These forms vary in severity, treatment needs, and long-term outcomes.\n\nChildren aged 1-18 years who are diagnosed with myocarditis based on clinical findings, cardiac biomarkers, echocardiography, and electrocardiography (with MRI when available) will be included. Patients with congenital heart disease or cardiomyopathy unrelated to myocarditis will be excluded.\n\nThe study will follow eligible patients prospectively over a 12-month period. Detailed clinical assessment, laboratory tests, echocardiographic findings, and management strategies will be recorded. Special attention will be given to the role of corticosteroids and intravenous immunoglobulin (IVIG) in treatment. Outcomes including recovery of cardiac function, need for intensive care, and survival will be assessed.\n\nBy analyzing the clinical presentation, treatment, and prognosis of different myocarditis phenotypes, this study aims to improve the understanding of disease patterns in children and provide evidence to guide future management.",[110,24],[134,135],"Viral Myocarditis","Cardiogenic Shock","2025-09-14",{"date":138,"type":32},"2025-09-16",{"date":140,"type":20},"2026-06-01",{"date":142,"type":20},"2027-08-01",{"name":144,"class":39},"Assiut University",{"id":146,"slug":147,"hasResults":11,"nctId":148,"briefTitle":149,"officialTitle":150,"acronym":151,"eligibilityCriteria":152,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":153,"targetDuration":4,"studyType":77,"phases":155,"briefSummary":156,"conditions":157,"keywords":159,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":164,"lastUpdatePostDateStruct":165,"startDateStruct":167,"completionDateStruct":169,"leadSponsor":171,"locationsCount":173},"100465071","phase-3-abatacept-in-immune-checkpoint-inhibitor-myocarditis-100465071","NCT05335928","Abatacept in Immune Checkpoint Inhibitor Myocarditis","AbatacepT foR ImmUne Checkpoint Inhibitor Associated Myocarditis (ATRIUM): A Phase 3, Investigator-Initiated, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept in ICI Myocarditis","ATRIUM","Inclusion Criteria:\n\n1. Must have provided informed consent in a manner approved by the Investigator's Institutional Review Board (IRB) prior to any study-related procedure being performed. If a participant is unable to provide informed consent due to his\u002Fher medical condition, the participant's legally authorized representative may consent on behalf of the study participant, as permitted by local law and institutional Standard Operating Procedures;\n2. Aged greater than or equal to 18 years at the time of informed consent;\n3. Recent use of an FDA-approved immune checkpoint inhibitor (ICI, defined as administered an immune checkpoint inhibitor ≤ 6 months of myocarditis diagnosis), alone or in combination with other cancer therapies (i.e. chemotherapy, radiation therapy or targeted therapy). The FDA-approved ICI could be given as part of a clinical trial but not in combination with a new investigational agent which may cause myocarditis;\n4. A diagnosis of myocarditis.\n5. Hospitalized at the time of randomization;\n6. On 1000 mg of solumedrol per day for myocarditis or with an intent to initiate 1000 mg of solumedrol per day for myocarditis within 24 hours of first administration of study drug;\n7. Serum evidence of ongoing myocardial injury: Serum evidence of ongoing myocardial injury will be defined as an institutional troponin (either conventional or high-sensitivity troponin I or T, using the standard institutional assay) with a value that is ≥5 times the upper limit of the reference standard normal for that institution. The troponin assay may be adjusted based on sex depending on institutional standards. This value of troponin of ≥5 times above the institutional upper limits of normal value must be noted within 10 days prior to potential randomization. The 10-day period can be in the outpatient or inpatient setting. For example, a participant with a troponin value that on one occasion was ≥5 times the upper limits of institutional normal in the 10-day window prior to potential randomization (whether in the inpatient or outpatient setting), but later decreases below that threshold, typically due to starting corticosteroids, would still be considered eligible;\n8. The following laboratory parameters, not older than 48 hours at the time of randomization, and measured as part of usual care:\n\n   * Total white blood cell (WBC) count \\>2,500\u002Fμl\n   * Absolute neutrophil count (ANC) \\>1,500\u002FμL\n   * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\\u003C20 times the upper limit of the institutional normal ranges;\n9. Women of childbearing potential (i.e., not postmenopausal, or surgically sterilized) must have a negative highly sensitive urine or serum pregnancy test prior to randomization. Participating women of childbearing potential must be willing to consistently use effective methods of contraception from screening until at least 90 days after administration of the last dose of study drug. Participating men must also be willing to consistently use effective methods of contraception from screening until at least 90 days after administration of the last dose of study drug; and\n10. Must be willing and able to abide by all study requirements and restrictions.\n\nExclusion Criteria:\n\n1. Must not have experienced any of the following (as defined in the section on the primary endpoint) in the 30-day period prior to randomization:\n\n   * A sudden cardiac arrest\n   * Cardiogenic shock as defined. A significant bradyarrhythmia (Mobitz type II second degree atrioventricular block or third degree (complete) atrio-ventricular (AV) block, for which an intervention with a temporary or permanent pacemaker is completed or recommended).\n   * A significant tachyarrhythmia (ventricular fibrillation of any duration or sustained ventricular tachycardia (\\>30 seconds, \\>120 beats per minute); or a ventricular tachyarrhythmia requiring intervention.\n2. Recent (≤2 month) exposure to abatacept or belatacept.\n3. Concurrent or recent (≤2 month) use of the following non-corticosteroid immunosuppressive therapies prior to randomization: mycophenolate, JAK STAT inhibitors (including but not limited to upadacitinib, tofacitinib, baricitinib, and filgotinib), tacrolimus, anti-thymocyte globulin, alemtuzumab, infliximab, and plasma exchange. The use of intravenous immunoglobulin is permitted prior to randomization and during study treatment.\n4. Currently enrolled in another interventional study utilizing systemic agents for the management of ICI-related toxicities.\n5. Female who is pregnant, breastfeeding, or is considering becoming pregnant during the study or for approximately 90 days after the last dose of study drug.\n6. Male who is considering fathering a child or donating sperm during the study or for approximately 30 days after the last dose of study drug.\n7. Any active, chronic, or recurrent viral infection that, based on the investigator's clinical assessment, makes the participant an unsuitable candidate for the study. These may include hepatitis B virus (HBV) or hepatitis C virus (HCV), recurrent or disseminated (even a single episode) herpes zoster, and disseminated (even a single episode) herpes simplex. Active HBV and HCV are defined as: HBV: hepatitis B surface antigen (HBs Ag) positive (+) or detected sensitivity on the HBV deoxyribonucleic acid (DNA) polymerase chain reaction (PCR) qualitative test for Hepatitis B core antibody (HBc Ab) positive (+) participants; HCV: HCV ribonucleic acid (RNA) detectable in any participant with anti-HCV antibody (HCV Ab). Patients with active Covid-19 infection will be excluded. This is defined as the period of ongoing symptoms in the setting of a positive Covid-19 test, or until 10 days after symptom onset and after resolution of fever for at least 24 hours, without the use of fever-reducing medications.\n8. Known active tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB, suspected or known systemic bacterial or fungal infections;\n9. Receipt of any live vaccine within four weeks prior to the first dose of study drug, or expected need of live vaccination during study participation including at least 90 days after the last dose of IV study drug.\n10. Any medical condition that could interfere with, or for which the treatment might interfere with, the conduct of the study or interpretation of the study results, or that would, in the opinion of the Investigator, increase the risk of the participant by participating in the study.\n11. Any factors that, in the Investigator's opinion, are likely to interfere with study procedures, such as history of noncompliance with scheduled appointments.",{"count":154,"type":20},390,[79],"The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure.",[24,158],"Cancer",[160,110,161,162,163],"Immune checkpoint Inhibitor","Abatacept","Immune therapy","Immune related adverse events","2025-09-04",{"date":166,"type":32},"2025-09-10",{"date":168,"type":32},"2022-07-02",{"date":170,"type":20},"2027-04-20",{"name":172,"class":39},"Massachusetts General Hospital",31,{"id":175,"slug":176,"hasResults":11,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":180,"eligibilityCriteria":181,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":182,"enrollmentInfo":183,"targetDuration":4,"studyType":77,"phases":185,"briefSummary":186,"conditions":187,"keywords":188,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":198,"completionDateStruct":200,"leadSponsor":202,"locationsCount":204},"100450838","phase-3-myths---myocarditis-therapy-with-steroids-100450838","NCT05150704","MYTHS - MYocarditis THerapy With Steroids","Single Blind Randomized Controlled Trial to Assess the Safety and Efficacy of High Dose Pulse Intravenous Corticosteroid Therapy to Treat Patients With Complicated\u002FFulminant Acute Myocarditis","MYTHS","Inclusion Criteria:\n\n* Patients admitted to hospital for suspected AM\n* Age 18 years or older and below 70 years (18-69 years)\n* Acute HF with clinically suspected acute myocarditis based on an N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration of 1600 pg\u002FmL or more or a B-type natriuretic peptide (BNP) concentration of 400 pg\u002FmL or more;\n* Left ventricular ejection fraction (LVEF)\\\u003C41% and left ventricular end diastolic diameter (LV-EDD)\\\u003C56 mm (parasternal long-axis view) on echocardiogram;\n* Increased troponin (3x upper reference limit \\[URL\\]) at the time of randomization;\n* Clinical onset of cardiac symptoms within 3 weeks from randomization;\n* Excluded coronary artery disease by coronary angiogram in subjects ≥46 years of age, in case myocarditis is not histologically proven;\n* Randomization within 120 hours from hospital admission.\n\nExclusion Criteria:\n\n* Known systemic autoimmune disorder or other conditions at the time of randomization where immunosuppression is assumed useful. Patients in whom a systemic autoimmune disorder will be diagnosed during hospitalization will be included in the study if randomized, including patients with a diagnosis of cardiac sarcoidosis or giant cell myocarditis (GCM). Both patients included in the corticosteroids-treatment arm or in the placebo-treatment arm can receive the standard immunosuppressive therapy used in the center since the diagnosis of a systemic autoimmune disorder, or cardiac sarcoidosis or GCM;\n* Patients already on oral\u002FIV chronic corticosteroid therapy or other chronic immunosuppressive therapies (colchicine or nonsteroidal anti-inflammatory drugs \\[NSAIDs\\] are not considered immunosuppressive drugs);\n* Contraindication to corticosteroids, including allergies to this medication and its excipients;\n* Patients with persistent peripheral eosinophilia (persistent Eosinophil count \\>7% of the leukocytes) or known hypereosinophilic syndrome at the time of randomization. Patients in whom eosinophilic myocarditis will be diagnosed on endomyocardial biopsy (EMB) will be included in the study if already randomized. Both patients included in the corticosteroids-treatment arm or in the placebo-treatment arm can receive the standard immunosuppressive therapy used in the center since the diagnosis;\n* Myocarditis associated with the ongoing administration of anti-cancer immune checkpoint inhibitor (ICI) agents;\n* Previously known chronic cardiac disease (i.e., previous cardiomyopathy) that does NOT include previous myocarditis if there is a functional recovery at the time of screening);\n* Evidence of active bacterial or fungal infectious disease (presence of fever or increased C-reactive protein are not considered exclusion criteria), or suspected bacterial\u002Ffungal infection associated with increased levels of procalcitonin (cut-off \\>10 ng\u002FmL), if the laboratory exam is available in the center;\n* Known chronic infective disease, such as HIV infection or tuberculosis;\n* out-of-hospital cardiac arrest;\n* t-MCS instituted more than 48 hours before randomization;\n* Patients clinically judged too sick to initiate t-MCS (i.e., irreversible multiorgan failure);\n* Echocardiographic presence of images suggestive of other cardiac diseases (i.e. endocarditis)\n* Participants involved in another clinical trial;\n* Pregnant women (known pregnancy) or POSITIVE human chorionic gonadotropin (HCG) test measures (urine\u002Fblood) for women of 18-50 years of age.\n* Any other significant disease with expected life expectancy \\\u003C12 months (i.e., evidence of irreversible severe brain injury) or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.","69 Years",{"count":184,"type":20},288,[79],"This is a phase III, multi-center international, single blind randomized controlled trial to test the efficacy of pulsed intravenous (IV) methylprednisolone versus standard therapy on top of maximal support in patients with Acute myocarditis (AM).",[24],[189,190,110,191,192,193,194],"Acute Myocarditis","Corticosteroid therapy","Trial","Immunosuppression","Acute heart failure","Fulminant acute myocarditis","2025-07-30",{"date":197,"type":32},"2025-07-31",{"date":199,"type":32},"2021-10-07",{"date":201,"type":20},"2028-12",{"name":203,"class":39},"Niguarda Hospital",49,{"id":206,"slug":207,"hasResults":11,"nctId":208,"briefTitle":209,"officialTitle":209,"acronym":210,"eligibilityCriteria":211,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":212,"targetDuration":214,"studyType":21,"phases":4,"briefSummary":215,"conditions":216,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":95},"100585161","creation-of-a-national-multicenter-platform-for-the-study-of-inflammatory-myocardial-disease-pre-myo-cohort-100585161","NCT06898762","Creation of a National Multicenter Platform for the Study of Inflammatory Myocardial Disease: Pre-MYO Cohort","PREMYO","Inclusion Criteria:\n\n• Presence of at least one compatible symptom and at least one objective finding in diagnostic tests (Figure 2), according to the consensus document of the European Society of Cardiology (1):\n\nA. Clinical presentation:\n\n* Acute chest pain: pericardial or pseudo-ischemic.\n* Dyspnea on exertion or at rest for up to 3 months.\n* Dyspnea on exertion or at rest for 3 months - 1 year.\n* Unexplained palpitations \u002F arrhythmias, sudden death recovered.\n* Unexplained cardiogenic shock.\n\nB. Findings in complementary tests:\n\n* ECG: new onset AV block, new onset bundle branch block, ST segment elevation\u002Fdepression, T wave inversion\n* Elevation of TnI\u002FTnT\n* Segmental or global contractility alterations not explained by other causes\n* Positive Lake Louise criteria in cardiac MRI (13) (Annex III Figure S1) • Patients who have given their informed consent.",{"count":213,"type":20},3000,"3 Years","The objectives of this project are: 1) to comprehensively characterize a large national cohort of patients with suspected myocarditis, their clinical phenotype, care management, blood and imaging biomarkers, epidemiological, environmental and genetic data; 2) to retrospectively validate the accuracy of the new hsa-RNA-Chr8:96 biomarker for the diagnosis of myocarditis compared to conventional diagnosis; 3) to identify acquired and inherited mutations, and their interaction with the environment, which explain the susceptibility to myocarditis, its severity and response to treatment; 4) to study the lower incidence in women and the influence of age, considering socio-health and genetic factors.",[24,217],"Inflammatory Cardiomyopathy","2025-03-21",{"date":220,"type":32},"2025-03-27",{"date":222,"type":32},"2023-04-09",{"date":224,"type":20},"2028-12-31",{"name":226,"class":39},"Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia",{"id":228,"slug":229,"hasResults":11,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":233,"eligibilityCriteria":234,"healthyVolunteers":11,"sex":16,"minAge":235,"maxAge":4,"enrollmentInfo":236,"targetDuration":4,"studyType":77,"phases":238,"briefSummary":240,"conditions":241,"keywords":242,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":244,"lastUpdatePostDateStruct":245,"startDateStruct":247,"completionDateStruct":249,"leadSponsor":251,"locationsCount":4},"100584968","phase-2-pulse-corticosteroids-orand-immunoglobulins-to-treat-fulminant-myocarditis-100584968","NCT06896253","Pulse Corticosteroids Or\u002Fand Immunoglobulins to Treat Fulminant Myocarditis","Pulse Corticosteroids Or\u002Fand Immunoglobulins to Treat Fulminant Myocarditis: a Double-blind Randomized Controlled Adaptive Trial the CORIUM Study","CORIUM","Inclusion Criteria:\n\n* 1\\. Fulminant myocarditis defined by\n\n  * the acute illness (\\\u003C1 month from symptom onset),\n  * hemodynamic compromise due to cardiogenic shock (confirmed by echocardiography) or electrical storm,\n  * elevated plasma cardiac troponin \\> twice normal value\n  * need for hemodynamic support (inotropes or temporary mechanical circulatory support) for less than 72 hours in the absence of an ischemic cause or other pre-existing cardiomyopathies Noticeably, a coronary angiogram should be performed in patients ≥40 years of age when myocarditis has not been proven histologically. Besides, an endomyocardial biopsy will not be mandatory to fulfill the definition of fulminant myocarditis.\n\n    2\\. Signed informed consent from the patient, a close relative or surrogate or a family member or a legal representative for minor patient.\n  * Adult : According to the specifications of emergency inclusion, randomization without the close relative\u002Fsurrogate consent could be performed if the patientis unable to give his\u002Fher consent and when the close relative\u002Fsurrogate\u002Ffamily member are absent. Close relative\u002Fsurrogate\u002Ffamily member consent will be asked as soon as possible after randomization. The patient will be asked as soon as possible to give his\u002Fher consent for the continuation of the trial when his\u002Fher condition will allow.\n  * Minor : According to the specifications of emergency inclusion, randomization could be performed when legal representative are absent. Legal representative consent will be asked as soon as possible after randomization 3. Social security registration (AME excluded)\n\nExclusion Criteria:\n\n* 1\\. Age \\\u003C15 2. Pregnancy or breastfeeding or baby delivery \\\u003C6 months 3. Initiation of inotropes or temporary mechanical circulatory support \\>72 hours 4. Resuscitation \\>20 minutes (cumulative low-flow time \\> 20 minutes ) 5. Pre-existing ischemic or dilated cardiomyopathy or Tako-Tsubo evaluated by echocardiography.\n\n  6\\. Known systemic autoimmune disorder or other conditions requiring immunosuppression 7. Patients with peripheral eosinophilia (≥1000 G\u002FL) 8. Myocarditis associated with anti-cancer immune checkpoint inhibitor agents 9. Active severe bacterial or fungal infectious disease 10. Patient moribund on the day of randomization, SAPS II \\>90 11. Contraindication or allergies to corticosteroids or immunoglobulins or any components of the formulations or their excipients 12. Patients already on corticosteroids or receiving IVIG 13. Participation in another interventional study or being in the exclusion period at the end of a previous study.\n\n  14\\. Patients with an uncontrolled psychotic condition Patients with known anti-IgA antibodies in line with the contraindications of methylprednisolone IV and of IVIg based products respectively","15 Years",{"count":237,"type":20},120,[239],"PHASE2","Fulminant myocarditis (FM) is the most severe manifestation of acute myocarditis, an acute inflammatory myocardial disease most often triggered by viral infections.\n\nCurrently, the most accepted definition of FM requires acute illness, hemodynamic compromise due to cardiogenic shock, and need for hemodynamic support (inotropes and\u002For temporary mechanical circulatory support (t-MCS) in the absence of an ischemic cause or other pre-existing cardiomyopathies. Unfortunately, there is a paucity of evidence-based management strategies for this disease and the management of patients affected by FM often varies according to local experience and practice with the role of immunosuppression being the most debated issue.\n\nBesides, due to inconsistent results obtained in several studies and frequent spontaneous recovery with supportive therapy alone, immunosuppression is largely debated in the setting of lymphocytic myocarditis (LM). Among available medications for this disease, corticosteroids are often used despite a lack of clear evidence in the context of FM. Similarly, intravenous immunoglobulin (IVIG) has both antiviral and anti-inflammatory effects on myocarditis. In adults, a recent meta-analysis based on case series showed that IVIG therapy significantly reduced in-hospital mortality, improved the left ventricular ejection fraction, and significantly increased the survival rate in patients with FM. More recently, FM among patients with COVID-19, including post-infectious multisystem inflammatory syndrome, has been reported in young adult patients. These severe forms have been successfully treated with intravenous corticosteroids and IVIG, highlighting the relevance of the systemic inflammatory response in determining cardiac injury in COVID-19, even though more evidence is needed.",[24],[243],"Fulminant myocarditis","2025-03-19",{"date":246,"type":32},"2025-03-26",{"date":248,"type":20},"2025-04",{"date":250,"type":20},"2029-11",{"name":119,"class":39},{"id":253,"slug":254,"hasResults":11,"nctId":255,"briefTitle":256,"officialTitle":256,"acronym":4,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":258,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":260,"conditions":261,"keywords":4,"overallStatus":85,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":95},"100577898","role-of-spectral-ct-in-the-diagnosis-of-myocarditisminoca-in-patients-undergoing-cardioct-investigations-for-acute-chest-pain-100577898","NCT06804278","Role of Spectral CT in the Diagnosis of Myocarditis\u002FMINOCA in Patients Undergoing cardioCT Investigations for Acute Chest Pain","Inclusion Criteria:\n\n* Age greater than or equal to 18 years;\n* patients with acute chest pain and indication for triple-rule-out CT or coronary CT examination, i.e. low\u002Fintermediate probability of acute coronary artery disease, ECG and\u002For troponin not diagnostic or altered;\n* Obtaining informed consent\n\nExclusion Criteria:\n\n* Absolute contraindications to CT examination and\u002For iodinated mdc administration (i.e. pregnancy, severe renal impairment in non-dialysis patients with GFR \\\u003C 15-30 ml\u002Fmin\u002F1.73m2 );\n* CT examinations that do not allow diagnostic information to be provided because they are assessed as quality too scarce and not interpretable (affected by artifacts such as motion artifacts)",{"count":259,"type":20},200,"It is a spontaneous, observational cross-sectional and single-center imaging (CT and MRI) study, coupled with clinical-laboratory data. Patients with acute chest pain with low\u002Fintermediate probability of coronary artery disease, ECG and\u002For troponin not diagnostic or altered according to the current \"standards of care\" used in the ED\u002FDepartment (ESC Guidelines 2020), will be enrolled consecutively and will undergo CT examinations by means of \"Spectral\" CT technology. CT investigation will allow to identify any non-myocarditis causes of acute chest pain and by means of spectral analysis of CT images it will try to identify signs suggestive of damage myocardial (such as ECV, LIE, hyperemia and edema).",[262,263,264,24,265],"Cardiac Imaging Techniques","Cardiac Imaging","Myocardial Disease","Minoca","2025-01-29",{"date":268,"type":32},"2025-02-03",{"date":270,"type":32},"2024-11-18",{"date":272,"type":20},"2027-02",{"name":274,"class":39},"IRCCS Azienda Ospedaliero-Universitaria di Bologna"]