Clinical Research Directory

MYocarditis and/or Pericarditis Following mRNA COVID-19 VACCination National Surveillance Study

Myocarditis is inflammation of the heart muscle. Pericarditis is inflammation of the lining surrounding the heart muscle. Symptoms of these conditions can include pain in the chest and rapid or irregular heartbeat. There are many different causes for myocarditis and pericarditis including COVID-19 infection. The MYCOVACC study will identify patients using local screening strategies, including research communications, care provider referrals, and medical record review. The retrospective component of the study will collect information about patients suffering from vaccine associated myopericarditis and COVID-19 associated myopericarditis. Consenting patients will then be prospectively followed according to standard of care protocols. The main objectives of MYCOVACC are to describe the rate of major adverse cardiovascular events, functional outcomes including quality of life, and myocardial recovery through imaging.

Heart@Home Safety and Efficacy of Hospital-at-Home Care Versus Standard Hospitalization in Cardiac Patients

Hospital-at-Home (H@H) programs provide hospital-level acute care in the patient's home and may reduce healthcare utilization while improving patient experience. Although H@H models have been evaluated in several acute medical populations, evidence regarding their safety and efficacy in a broad population of patients with acute cardiovascular conditions remains limited. HeaRt@Home is a prospective, randomized controlled trial designed to evaluate the safety and efficacy of H@H compared with standard in-hospital care in clinically stable cardiac patients admitted to Tel Aviv Sourasky Medical Center. The study will enroll 150 adults hospitalized for selected cardiovascular conditions, including acute myocardial infarction following uncomplicated percutaneous coronary intervention, pericarditis or myocarditis, pulmonary embolism, post transcatheter valvular intervention, acute or worsening heart failure, or following Pacemaker or Implantable Cardioverter-Defibrillator Implantation. Eligible patients will be assessed within the first 12-24 hours following clinical intervention and randomized to either continued standard hospitalization or H@H care. Patients assigned to H@H will receive hospital-level care at home, including continuous remote monitoring of vital signs and cardiac rhythm, 24/7 access to the hospital monitoring center, at least one daily home visit by a nurse, and at least one daily virtual assessment by a cardiologist. Laboratory testing, imaging, oral and intravenous medications, oxygen therapy, and additional specialist consultations will be provided at home as clinically indicated. A predefined emergency pathway will enable rapid transfer back to the hospital when required. The study will assess safety outcomes including all-cause mortality, hospital-acquired infections, hemodynamic deterioration, acute kidney injury, venous thromboembolism, medication errors, 30-day readmission, and 30-day mortality. Patient experience will be evaluated using the 15-item Picker Patient Experience Questionnaire. Secondary outcomes will include length of stay, healthcare resource utilization, mobility and physical activity, sleep, arrhythmias, need for escalation to hospital care, and psychological outcomes. The study aims to determine whether a structured, technology-supported H@H model can provide safe and effective hospital-level care for appropriately selected cardiovascular patients while potentially improving patient experience and optimizing healthcare resource utilization.

Abatacept in Immune Checkpoint Inhibitor Myocarditis

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.

MCE Molecular Imaging for Myocarditis

Inflammation of the heart (myocarditis) is a serious condition that can cause heart failure, abnormal heart rhythms, cardiac arrest, and death. Rapid diagnosis of this condition is key to reversing it. The purpose of this study is to determine whether myocarditis such as that which occurs with viral illness, autoimmune conditions, or certain therapies (i.e. immune checkpoint inhibitors) can be diagnosed using a new form of ultrasound imaging of the heart (echocardiography) that uses a contrast agent that is targeted to inflammation (Sonazoid).

One-year Prognostic Impact of Microcirculation Assessed by NH IMR Angio in Patients Hospitalized for Acute Myocarditis

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: Is there a correlation between impaired microcirculation and the occurrence of serious clinical events in this population of patients?

Ventricular Arrhythmia After Myocarditis in Sportsman

The study aims to assess the prevalence of ventricular rhythmic disorder after an acute myocarditis in sportsmen. 50 patients with acute myocarditis, confirmed by MRI, will be assessed by ECG Holter and Treadmill stress test during a 1-year follow-up.

Arrhythmic Risk in Myocarditis Outcome Research

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: * What is the incidence of sustained ventricular arrhythmias during the index hospitalization in patients with acute myocarditis? * What clinical, biological, electrocardiographic, and imaging factors predict the occurrence of sustained ventricular arrhythmias during hospitalization and after discharge? Researchers 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. Participants' medical records from 2020 to 2024 will be reviewed to collect: * Baseline demographic, clinical, biological, electrocardiographic, and imaging data at admission * In-hospital management strategies and outcomes, including mortality, cardiogenic shock, and heart replacement therapy * Long-term follow-up data including VA recurrence, sudden cardiac death, and development of cardiomyopathy, with censoring applied on January 1, 2026

Non-Steroidal Anti-Inflammatory Drugs in Acute Myocarditis

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.

French Registry of CMR Late Gadolinium Enhancement in Myocarditis

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.

Outcome of Clinical Phenotypes of Pediatric Myocarditis at Assiut University Children Hospital

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. Children 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. The 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. By 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.

MYTHS - MYocarditis THerapy With Steroids

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).

Creation of a National Multicenter Platform for the Study of Inflammatory Myocardial Disease: Pre-MYO Cohort

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.

Pulse Corticosteroids Or/and Immunoglobulins to Treat Fulminant Myocarditis

Fulminant myocarditis (FM) is the most severe manifestation of acute myocarditis, an acute inflammatory myocardial disease most often triggered by viral infections. Currently, the most accepted definition of FM requires acute illness, hemodynamic compromise due to cardiogenic shock, and need for hemodynamic support (inotropes and/or 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. Besides, 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.

Role of Spectral CT in the Diagnosis of Myocarditis/MINOCA in Patients Undergoing cardioCT Investigations for Acute Chest Pain

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/intermediate probability of coronary artery disease, ECG and/or troponin not diagnostic or altered according to the current "standards of care" used in the ED/Department (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).