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Myocarditis clinical trials

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NCT ID: NCT05046002 Recruiting - Myocarditis Clinical Trials

COVID-19 Vaccine-induced Inflammatory Heart Disease Prevalence Registry

COVID-VIHPR
Start date: August 11, 2021
Phase:
Study type: Observational [Patient Registry]

Myocarditis and pericarditis are inflammatory diseases of the myocardium and pericardium, and can be related to different causes, including vaccines. In the past, some people developed inflammatory heart disease after receiving a live or inactive virus vaccine (smallpox vaccine or flu vaccine). Myocarditis was also seen in people with COVID-19. More recently, many countries reported that some people have developed an inflammatory condition of the myocardium or pericardium after receiving a vaccine for COVID-19. After the COVID-19 vaccination campaigns, doctors have noticed more people presenting to the Emergency Department with chest pain and shortness of breath after receiving the vaccine, symptoms that resemble myocarditis or pericarditis. These symptoms may start between 2 to 10 days following vaccination and are frequently noticed after the second dose of the vaccines. While pericarditis seems to affect people of various age groups and gender, myocarditis is more commonly seen in young males. The study will consist of three components. First, the vaccine-induced inflammatory heart disease registry will be established. It will include a retrospective cohort study (chart review). Second, patients with persistent symptoms will be invited to participate in additional research-blood work and a 3-month telephone interview, as some of the patients may display chronic symptoms after developing the condition. Third, there will be a prospective, pragmatic design case-control study. We will collect clinical information and include blood samples for biomarkers twice for cases and once for controls and retrospective patients with persistent symptoms. Follow-up telephone interview will be conducted at the 3 months, 6 months, 12 months and yearly up to 4 years. A record search will also be performed at 6 months, 12 months and yearly for 4 years. The retrospective component of the study will be conducted by identifying patients previously diagnosed with this condition at participating centres.

NCT ID: NCT04865900 Recruiting - Covid19 Clinical Trials

Prevalence of Perimyocarditis After Covid-19 Vaccine

Start date: March 9, 2021
Phase:
Study type: Observational [Patient Registry]

The aim of this study is to determine whether there is a higher prevalence of perimyocarditis after undergoing vaccination for Covid-19.

NCT ID: NCT04844151 Recruiting - Myocarditis Clinical Trials

Acute Myocarditis Registry With Prognostic, Histologic, Immunologic, Biological, Imaging and Clinical Assessment

AMPHIBIA
Start date: January 23, 2022
Phase:
Study type: Observational [Patient Registry]

The AMPHIBIA study is an observational ambispective and prospective cohort that aim to describe the histologic, immunologic, biological, imaging, genetic and clinical characteristics of the patients hospitalized for an acute myocarditis and to evaluate their association with prognosis.

NCT ID: NCT04673409 Recruiting - Myocarditis Clinical Trials

CMR Imaging of Autoimmune Diseases

Start date: November 24, 2020
Phase:
Study type: Observational

Myocarditis is an important clinical problem which can can occur as a result of viral infections and autoimmune rheumatic diseases. Cardiac MRI is an important non-invasive means of making a diagnosis. However, current MRI techniques have significant limitations. Firstly, in order to create high-quality pictures, patients are required to hold their breath several times for multiple lengths of time. They often struggle with this due to underlying heart/lung problems. This can adversely affect the overall quality and image interpretation. Secondly, current techniques create 2D images that are potentially underestimating the presence and severity of any tissue inflammation/ injury. This may result in inappropriate treatment, particularly for patients with underlying autoimmune systemic disease who require immunosuppression. Diagnosis by MRI rests on detecting tissue injury through T2 and T1-weighted sequences which detect tissue inflammation and tissue injury. The purpose of this study is to evaluate the diagnostic accuracy of novel 3D free-breathing sequences for T2-weighted and fibrosis/ LGE imaging. Patients with suspected isolated myocarditis (viral/idiopathic) or myocarditis as part of an autoimmune systemic disease will be recruited to ensure that the novel techniques are tested in a broad spectrum of patients with inflammatory heart muscle disease.

NCT ID: NCT04654988 Recruiting - Heart Failure Clinical Trials

Study to Evaluate the Efficacy of Immunosuppression in Myocarditis or Inflammatory Cardiomyopathy.

IMPROVE-MC
Start date: December 1, 2022
Phase: Phase 4
Study type: Interventional

Myocarditis can result in numerous complications, but there is paucity of data regarding optimal therapy, short- and long-term effects of possibly effective immunosuppressive therapy. The IMPROVE-MC study will provide high-quality scientific data about efficacy and safety of immunosuppressive therapy, non-invasive (MRI, biomarkers) and invasive diagnostics tests (endomyocardial biopsy), and prognosis in myocarditis. The objective of this multicenter, prospective, randomized, double-blind placebo-controlled trial is to assess the efficacy and safety of 12 - month treatment with prednisone and azathioprine comparing to placebo on top of guideline-recommended medical therapy in patients with biopsy-proven virus negative myocarditis or inflammatory cardiomyopathy and reduced ejection fraction (LVEF ≤ 45%). The study will also assess persistence of the treatment effects after 12 months.

NCT ID: NCT04612296 Recruiting - Cardiomyopathies Clinical Trials

The Heart Hive - Cardiomyopathy Study

Start date: November 9, 2019
Phase:
Study type: Observational [Patient Registry]

This is an online registry and database of patients with cardiomyopathy and myocarditis, coupled with an observational study of DCM and HCM.

NCT ID: NCT04589156 Recruiting - Cardiomyopathy Clinical Trials

Recurrent Acute Myocarditis Registry

RAM
Start date: January 1, 2018
Phase:
Study type: Observational [Patient Registry]

The association between myocardial inflammation (clinically represented by acute myocarditis episodes) and the later development of an arrhythmogenic cardiomyopathy is widely elusive.

NCT ID: NCT04527835 Recruiting - Viral Myocarditis Clinical Trials

Presentation, Clinical Course and Patterns of Myocardial Damage Due to Viral Myocarditis

Start date: October 1, 2020
Phase:
Study type: Observational

Presentation, Clinical Course and Patterns of Myocardial Damage due to Viral Myocarditis

NCT ID: NCT04521790 Recruiting - Arrhythmia Clinical Trials

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

MYOCAR
Start date: January 30, 2018
Phase:
Study type: Observational [Patient Registry]

Myocarditis is a complex inflammatory disease, usually occurring secondary to viral infections, autoimmune processes or toxic agents. Clinical presentations are multiple, including chest-pain, heart failure and a broad spectrum of arrhythmias. In turn, outcome is largely unpredictable, ranging from mild self-limiting disease, to chronic stage and progressive evolution towards dilated cardiomyopathy, to rapid adverse outcome in fulminant forms. Subsequently, myocarditis is often underdiagnosed and undertreated, and optimal diagnostic and therapeutic strategies are still to be defined. This study, both retrospective and prospective, originally single-center and subsequently upgraded to multicenter, aims at answering multiple questions about myocarditis, with special attention to its arrhythmic manifestations. 1. Optimal diagnostic workflow is still to be defined. In fact, although endomyocardial biopsy (EMB) is still the diagnostic gold standard, especially for aetiology identification, it is an invasive technique. Furthermore, it may lack sensitivity because of sampling errors. By converse, modern imaging techniques - cardiac magnetic resonance (CMR) in particular - have been proposed as alternative or complementary diagnostic tool in inflammatory heart disease. Other noninvasive diagnostic techniques, like delayed-enhanced CT (DECT) scan or position emission tomography (PET) scan, are under investigation. 2. Biomarkers to identify myocarditis aetiology, predisposition, prognosis and response to treatment are still to be defined. 3. Arrhythmic myocarditis is largely underdiagnosed and uninvestigated. Importantly, myocarditis presenting with arrhythmias requires specific diagnostic, prognostic and therapeutic considerations. At the group leader hospital, which is an international referral center for ventricular arrhythmias management and ablation, a relevant number of patients with unexplained arrhythmias had myocarditis as underlying aetiology. The experience of a dedicated third-level center is going to be shared with other centers, to considerably improve knowledge and management of arrhythmic myocarditis. 4. The role of CMR, as well as alternative noninvasive imaging techniques, in defining myocarditis healing is a relevant issue. In particular, optimal timing for follow-up diagnostic reassessment is still to be defined, in patients with myocarditis at different inflammatory stages, either with or without aetiology-dependent treatment. 5. Uniformly-designed studies are lacking, to compare myocarditis among different patient subgroups, differing by variables like: clinical presentations, myocarditis stage, associated cardiac or extra-cardiac diseases, aetiology-based treatment, associated arrhythmic manifestations, diagnostic workup, and devices or ablation treatment.

NCT ID: NCT04464655 Recruiting - Clinical trials for Coronary Artery Disease

A 10-Minute Cardiovascular Magnetic Resonance Protocol for Cardiac Disease

Start date: December 12, 2019
Phase:
Study type: Observational

This study aims to identify and assess new CMR techniques that can improve current CMR protocols.