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Background of the study Studies have shown that about one-third of patients with acute viral myocarditis (AVMC) eventually develop dilated cardiomyopathy (DCM), and that the autoimmune response to viral infection is key to the development of AVMC to DCM. A variety of antimyocardial autoantibodies (AHAs) are detected in the sera of patients with myocarditis. Among them, anti-β1AR antibodies are thought to contribute to the transition of AVMC to DCM possibly by promoting myocardial injury, cardiac remodeling, and impaired cardiac function. The role of anti-L-CaC antibodies in the evolution of AVMC to DCM is unknown, but they have been shown to induce ventricular tachycardia by increasing calcium inward flow and triggering early afterdepolarization, increasing the rate of sudden death and all-cause mortality in patients. Therefore, monitoring the levels of these antibodies may be useful in assessing the prognosis of patients with viral myocarditis. In this study, we propose to use a multicenter, prospective cohort study to further accurately assess the predictive value of these autoantibodies in the evolution of AVMC patients to DCM by detecting the serum levels of anti-β1AR antibodies and anti-L-CaC antibodies in AVMC patients and combining them with the clinical data and follow-up data, so as to provide prognostic biomarkers as well as targets for targeted interventions in AVMC.
Objective of the study A multicenter, prospective cohort study of the value of anti-β1AR and anti-L-CaC antibodies in the progression of AVMC patients to DCM, enrolling 300 AVMC patients, to further accurately assess the predictive value of anti-β1AR and anti-L-CaC antibodies in the progression of AVMC patients to DCM, and provide prognostic biomarkers and targeted interventions for AVMC. The study will provide prognostic biomarkers and targeted intervention for AVMC.
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence of evolution to DCM in patients positive for anti-β1AR antibodies and anti-L-CaC antibodies | End of months 1, 3 and 6 |
| Measure | Description | Time Frame |
|---|---|---|
| All-Cause Death, Rehospitalization for Heart Failure, or Sudden Death in Patients Positive for Anti-β1AR Antibodies and Anti-L-CaC Antibodies | End of months 1, 3 and 6 |
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Inclusion Criteria:
Exclusion Criteria:
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Viral myocarditis (VMC) is an inflammation of the myocardium caused by viral infections. Common viruses include coxsackievirus, adenovirus, cytomegalovirus, and influenza virus. The prognosis for patients with Acute viral myocarditis (AVMC) varies widely, with most patients recovering with treatment, but some progressing to dilated cardiomyopathy (DCM). Studies have shown that about one-third of patients with AVMC eventually develop DCM, and that the immune response following viral infection is key to the development of DCM in AVMC. Following viral infection, specific antigenic determinants within cardiomyocytes are exposed to the immune system, triggering an autoimmune response against the myocardium, leading to damage and dysfunction of cardiomyocytes.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Yuan | Contact | 86-13886121012 | yhelen13@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Cardiology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, 430022, China | Recruiting | Wuhan | Hubei | 430000 | China |
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Blood samples remaining after completion of routine clinical blood tests will be destroyed in accordance with the regulations of the hospitals in which the centers are located. The study doctor will take an additional 5ml of blood sample for AHA testing in addition to the routine clinical blood tests. Prior consent will be obtained from the patients before the blood samples are taken; after the completion of this study, the remaining blood samples from the additional 5 ml of blood samples will be approved by the Ethics Committee and will be used for future studies of DCM and the development of VMC in high-risk populations in accordance with ethical requirements.
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