DCM Anti-Heart Antibody Diagnostic Kit Study--assessment of the Predictive Value of Anti-beta1AR and Anti-L-CaC Antibodies in the Evolution to Dilated Cardiomyopathy in Patients With Acute Viral Myocarditis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of evolution to DCM in patients positive for anti-β1AR antibodies and anti-L-CaC antibodies
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meets diagnostic criteria for VMC
- •Clinical symptoms present for no more than 30 days
- •Age ≥ 18 years and ≤ 75 years
- •Subjects or their legal guardians are fully informed of the nature and risks of the study, participate voluntarily, and sign an informed consent form.
排除标准
- •Serious uncontrolled infection at enrolment ("uncontrolled" is defined as signs and symptoms of infection that persist without improvement despite antimicrobial or other treatment)
- •Uncontrolled active bleeding at enrollment
- •Systemic autoimmune disease such as systemic lupus erythematosus or diagnosed immunodeficiency disease at enrollment
- •Pregnancy or breastfeeding
- •Combination of serious diseases affecting survival, such as tumors, with a life expectancy shorter than 3 months
- •Patients with poor compliance who are unable to complete the full course of the study
- •Other conditions (e.g., overstimulation, sensitivity, cognitive impairment, mental illness, or substance abuse/addiction) that, in the judgment of the investigator, may increase the risk to the subject or interfere with the clinical study and judgment of the results.
结局指标
主要结局
Incidence of evolution to DCM in patients positive for anti-β1AR antibodies and anti-L-CaC antibodies
时间窗: End of months 1, 3 and 6
次要结局
- 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)