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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Cardiomyopathy

Study type: Observational

Funder types: Other

Identifiers

NCT02757742

NICM-002-FW

Details and patient eligibility

About

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

Full 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.

Enrollment: 356 patients

Sex: All

Ages: 10 to 65 years old

Volunteers: No Healthy Volunteers

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 ；

Trial design

356 participants in 1 patient group

Non-ischemic cardiomyopathy

Description:

Non-ischemic cardiomyopathy patients with baseline cardiac magnetic resonance LVEF≤35%