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临床试验/NCT05871632
NCT05871632尚未招募不适用

The China CardioMyopathy Registry Study

China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
5,000
试验地点
1
主要终点
number of participants with cardiovascular deaths

研究概览

简要总结

Cardiomyopathy is the most common inherited cardiovascular disease, showing family aggregation, so it has a huge psychological and economic burden on family members. Studying the clinical characteristics of patients with cardiomyopathy is helpful for further diagnosis, treatment and management, which has important clinical and social significance.

详细描述

In this study, patients hospitalized with cardiomyopathy as the primary discharge diagnosis in China are recruited prospectively after informed consent was given. The investigator will collect the baseline clinical characteristics of the patients at enrollment, including comprehensive physical examination, laboratory testing of blood and urine, electrocardiography, 24-hour Holter, echocardiography, MRI and other examinations if necessary. Data are collected with the use of case report forms (CRFs) and are entered into a web-based system. A 6 mL venous blood sample is obtained from consenting patients. Each participant is scheduled to be followed up by telephone every 12 months after admission to hospital.

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
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with primary discharge diagnosis meeting one of the following subtypes of cardiomyopathy were enrolled, including HCM, DCM, ACM, RCM, left ventricular non-compaction, cardiac amyloidosis, Fabry disease, Pompe disease, Danon disease, and PRKAG2 cardiac syndrome.

排除标准

  • Patients who refuse to sign the informed consent or decline follow-up.

结局指标

主要结局

number of participants with cardiovascular deaths

时间窗: an average of 1 year

including sudden cardiac death and deaths due to heart failure and stroke

次要结局

  • number of participants with heart failure(an average of 1 year)
  • number of participants with all-cause deaths(an average of 1 year)
  • number of participants with myocardial infarction(an average of 1 year)
  • number of participants with stroke(an average of 1 year)

研究者

发起方
China National Center for Cardiovascular Diseases
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Lei.Song,MD.&ph.D

Principal Investigator, Clinical Professor

China National Center for Cardiovascular Diseases

研究点 (1)

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The China CardioMyopathy Registry Study | 临床试验