Quantitive LGE Mass in Prediction of SCD in NICM Patients With Severe Cardiac Dysfunction

Completed

• Conditions: Cardiomyopathy

• Registration Number: NCT02757742
• Lead Sponsor: Fu Wai Hospital, Beijing, China

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2016-04-26
• Study First Submitted QC: 2016-04-27
• Study First Posted: 2016-05-02
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-09
• Last Update Posted: 2016-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

• 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%

Exclusion Criteria

• 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 ；

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sudden cardiac death(SCD)	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	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	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	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.

Secondary Outcome Measures

Name	Time	Method
Heart transplantation	six years	Participants were followed up every 6 months, if the patients received heart transplantation, the follow ups were terminated and time for heart transplantation were documented.
All-cause death(including cardiac death and non-cardiac death)	six years	Participants were followed up every 6 months and the survival status of participants were documented(death or not, if the patient was dead, time of death and cause of death were documented)

Trial Locations

Locations (1)

Fu Wai Hospital; 🇨🇳 Beijing, Beijing, China