View clinical trials related to Myocarditis.
Filter by:The purpose of this clinical trial is to learn about the safety and effects of the study vaccine (called COMIRNATY) for the potential prevention of COVID-19. This study is seeking participants who: 1. Are age <21 years. 2. Have presentation to participating medical center with evaluation in Emergency Room and/or hospitalization. 3. Received either the 1st, 2nd, 3rd or booster dose(s) of COMIRNATY within 7 days of symptom onset. 4. Meet criteria of Centers for Disease Control and Prevention case definition of probable or confirmed myocarditis/pericarditis 5. Are capable of giving signed informed consent/assent (by parents/legal guardians of minors and/or patients), which includes compliance with the requirements and restrictions listed in the Informed Consent/Assent Document and in this protocol OR meets criteria for waiver of consent. This study will examine the potential long-term effects associated with myocarditis/pericarditis following vaccination with COMIRNATY. The association of myocarditis/pericarditis in participants who received the study vaccine (COMIRNATY) compared with those associated with COVID-19 will also be examined. This will help us determine if COMIRNATY is safe and effective, and if there is a myocarditis/pericarditis association that should be noted. Participants will take part in this study for up to 5 years. During this time, they will receive complete cardiac imaging tests, and have follow up visits per guidance stated in the study protocol.
BNT162b2 vaccine has become one of the most prevalent vaccines against the COVID-19 and is currently the main vaccine used in Israel. Since marketing and the beginning of use of the vaccine, we and others have reported. of the development of post vaccination myocarditis. In this study the investigators wish to explore the long term impact on 150 patients who have been diagnosed with myocarditis or multisystem inflammatory syndrome (MIS) in the year following their diagnosis of Myocarditis.
The coronavirus disease 2019 (COVID-19) is an ongoing pandemic which has infected more than 160 million people and caused 3.4 million deaths worldwide till May 2021. With the recent rollout of COVID-19 vaccines globally and in Singapore, reports of rare but serious cardiovascular-related side effects started to appear. Although a link between adenovirus-based vaccines (AstraZeneca ChAdOx1 and J&J Ad26.COV2.S) and cerebral venous sinus thrombosis (CVST) and immune thrombocytopenia has been widely reported, these vaccines are current not in use in Singapore. Yet, acute myocarditis and other cardiovascular symptoms has also been observed to be associated with the two mRNA-based vaccines (Pfizer-BioNTech BNT162b2 and Moderna mRNA-1273) in-use in Singapore. In Singapore acute myocarditis is of particular concern with at least 12 cases reported by the Health Services Authority (HSA). The US FDA and EU authorities have confirmed there to be an association between the mRNA vaccines and myocarditis.The study aims to (1) To study possible mechanisms of COVID-19 vaccines in causing myocarditis in patients with confirmed vaccine-associated myocarditis (2) To risk stratify for vaccine-associated myocarditis in the at-risk population of young men (3) To identify potential preventative strategies to mitigate vaccine-associated myocarditis in high-risk individuals
Background The novel coronavirus disease 2019 (COVID-19) caused by an infection with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) has rapidly become a global pandemic with more than 190.000.000 infections and 4.250.000 reported deaths worldwide. SARS-CoV-2 vaccination plays an important role in containing the pandemic and the possible adverse complications of COVID-19. Large clinical trials have proven the safety and efficacy of the vaccines currently in use. Systemic reactions usually were mild, self-limiting and could be observed more often in younger vaccine recipients. Cases of myocarditis after vaccination have been reported for various vaccines. The new vaccines for SARS-CoV-2 also seem to be affected by this adverse reactions. The pathophysiology is uncertain so far. Aim Aim of this study is a systematic registration of myocarditis cases associated with SARS-CoV-2 vaccination which were diagnosed and/or treated in participating centers. The main goal of this study is the characterization of clinical manifestations and prognosis of the disease. Study Design Patient history, laboratory tests and cardiovascular imaging data of patients with suspected SARS-CoV-2 - vaccine associated myocarditis are documented. Patients with clinical suspicion of troponin-positive myocarditis within 30 days after receiving SARS-CoV-2 vaccine without evidence for apparent other causes e.g. infectious or autoimmune etiology were included. Clinical follow-up data is acquired.
The study is aimed at studying the direct efficacy of mycophenolate mofetil (mycophenolate mofetil, CellCept, Genentech, N015393/02, 12.08.2009) (in combination with corticosteroids (methylprednisolone, Metypred, Orion, 003467, 26.02.2016)) in the treatment of lymphocytic myocarditis: the effect on symptoms, structural and functional parameters of the heart, on the outcomes of lymphocytic myocarditis: mortality, the need for transplantation, other surgical interventions, the incidence of unwanted side effects, and forced cancellation (replacement) of the drug. To compare the data on the efficacy and safety of therapy with mycophenolate mofetil (in combination with corticosteroids) with the standard regimen of therapy for lymphocytic myocarditis (corticosteroids in combination with azathioprine), including in cases of forced replacement of drugs with each other.
Myopericarditis is a rare complication to messenger ribonucleic acid (mRNA) COVID-19 vaccines, especially in male adolescents and young adults. The risk in children 5-11 years old is unknown. In Denmark, the Pfizer-BioNTech mRNA COVID-19 vaccination was recommended from December 1, 2021 in individuals aged 5-11 years old. We aim to estimate the incidence of myopericarditis in children 5-11 years old after mRNA COVID-19 vaccination among vaccinated individuals based on a nationwide prospective population-based cohort study with detailed clinical phenotyping.
Introduction: Coronavirus disease 2019 (COVID-19) remains a major health issue resulting in >800,000 deaths as of 30th August 2020. A concerning discovery of COVID-19 is the involvement of the myocardium. Several case studies including one from our group (recent study publication in JACC Cardiovascular Imaging led by the principal investigator of this grant application) have demonstrated subclinical myocardial inflammation in patients using cardiac magnetic resonance imaging (CMR) who have recovered from COVID-19. Furthermore at a cellular level, a recent autopsy study indicated that the severe acute respiratory syndrome coronavirus-2 is present in the myocardial tissue. The study further described invasion and viral progeny occurring in the myocardial interstitial cells and as such is a concerning development with the longer-term implications being unknown. These concerns have been noticed by the cardiology and non-cardiology medical community, with some expressing concerns of a new cause for cardiomyopathy and heart failure secondary to COVID-195. Therefore, it is critical that further studies are conducted to determine the longer-term outcome for patients.
Multi-center, double-blind, placebo-controlled, parallel group design. Patients with myocarditis will be screened and, if eligible, randomized within 10 days of the diagnostic CMR to CardiolRx or placebo. CardiolRx is pharmaceutically produced Cannabidiol and is free of tetrahydrocannabinol (THC<5 ppm). The treatment period is 12 weeks; a last follow-up visit is scheduled one week after the last treatment, 13 weeks after randomization. Study assessments include Cardiac Magnetic Resonance imaging (CMR), ECG monitoring, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Columbia-Suicide Severity Rating Scale (C-SSRS) as well as physical exams and laboratory tests. The primary and secondary outcome parameters are measured by CMR. Additional outcomes include clinical endpoints and changes in inflammatory and biomarkers.
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).
It consists of evaluating the advantage of routine detection of phIGFBP-1 to reduce the total duration of hospitalization for patients with a risk of preterm labor before 32 weeks of gestation without increasing the number of preterm labour.