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临床试验/NCT02757742
NCT02757742已完成不适用

A Quantitive Late Gadolinium Enhancement(LGE) Mass Based Tool for Risk Prediction of Sudden Cardiac Death(SCD) in Non-ischemic Cardiomyopathy(NICM) Patients With Severe Cardiac Dysfunction

Fu Wai Hospital, Beijing, China1 个研究点 分布在 1 个国家目标入组 356 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
356
试验地点
1
主要终点
Sudden cardiac death(SCD)

研究概览

简要总结

The purpose of this study is to establish a quantitative LGE mass based scoring system (including LGE mass on cardiac magnetic resonance , clinical features, specific medical histories, et al) for risk prediction of sudden cardiac death in non-ischemic dilated cardiomyopathy patients with reduced left ventricular ejection fraction

详细描述

This is a Single-centered, Prospective, Observational Study. The study design included two phases. In Phase I, the investigators enrolled a set of consecutive patients with non-ischemic cardiomyopathy who performed contrast-enhanced cardiac magnetic resonance at baseline and had severe cardiac dysfunction (defined as cardiac magnetic resonance LVEF equal or less than 35% ) in FuWai Hospital from 2010 to 2013. The investigators collect patients' clinical baseline data and cardiac magnetic resonance specific data(Late gadolinium enhancement mass). All patients were followed up every six month by phone or clinical visits. The primary endpoint was composite of sudden cardiac death(SCD), ventricular arrhythmias(VAs) and SCD/VAs related Implantable Cardioverter defibrillator or cardiac resynchronization therapy-cardioverter defibrillator(ICD/CRTD) shock. The investigators plan to establish a quantitative LGE mass based model (including LGE mass on cardiac magnetic resonance, clinical features, specific medical histories, et al) for risk prediction of sudden cardiac death by analysing the phase I data(1-year model and 3-year model). In Phase II,the investigators will enroll another group of non-ischemic cardiomyopathy(NICM) patients from 2014 to 2015 to testify the risk prediction model(1-year model) the investigators have constructed in phase I. The investigators aim to find the real high risk NICM patients that may suffer from SCD or VAs in those with severe cardiac dysfunction.

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
10 Years 至 65 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Non-ischemic cardiomyopathy patients receiving optimal medical treatment for 3 months; Age range from 10 years to 65 years old; Baseline cardiac magnetic resonance LVEF≤35%

排除标准

  • Known associated obstructive coronary Heart disease(including history of myocardial infarction or acute coronary event); valvular heart disease; malignant carcinoma ; hypertensive heart disease; severe liver or kidney dysfunction ; plan to receiving heart transplantation ; patients refuse to or cannot receive cardiac magnetic resonance ; patients refuse to be followed up ;

结局指标

主要结局

Sudden cardiac death(SCD)

时间窗: Six years

SCD was defined as cardiac death occured in a short time period (2 hour of symptom), which were assessed by two separated doctors from the central laboratory.

Aborted cardiac arrest

时间窗: Six years

Aborted cardiac arrest were defined as patients with ventricular tachycardia, ventricular fibrillation or sudden cardiac death were saved by cardio-pulmonary resuscitation and electric defibrillation.

Documented appropriate ICD therapy for ventricular tachycardia

时间窗: Six years

Participants with ICD or CRTD implanted came to the clinic every 6 months for device's programming control. Shock related events were analyzed by two separated experienced electrophysiology doctor(more than 5 years),to identify if the shock is delivered by sustained ventricular tachycardia, ventricular fibrillation and sudden cardiac death.

Documented appropriate ICD therapy for ventricular fibrillation

时间窗: Six years

Participants with ICD or CRTD implanted came to the clinic every 6 months for device's programming control. Shock related events were analyzed by two separated experienced electrophysiology doctor(more than 5 years),to identify if the shock is delivered by sustained ventricular tachycardia, ventricular fibrillation and sudden cardiac death.

次要结局

  • All-cause death(including cardiac death and non-cardiac death)(six years)
  • Heart transplantation(six years)

研究者

发起方
Fu Wai Hospital, Beijing, China
申办方类型
Other
责任方
Principal Investigator
主要研究者

Fan Xiaohan

Associated director, head of Cardiology,Principal Investigation, Clinical Professor

Fu Wai Hospital, Beijing, China

研究点 (1)

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