Clinical trial NCT02757742: Quantitive LGE Mass in Prediction of SCD in NICM Patients With Severe Cardiac Dysfunction
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiomyopathy
Keywords: sudden cardiac death
ventricular arrhythmias
cardiopathy
late gadolinium enhancement
Lead sponsor: Fu Wai Hospital, Beijing, China
Sponsor class: OTHER
First posted: 2016-05-02
Enrollment: 356
Sex: ALL
Minimum age (years): 10
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chinese patients with non-ischemic cardiomyopathy

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.

Eligibility criteria: 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 ；

Primary outcomes:
measure: Sudden cardiac death(SCD)
timeFrame: Six years
measure: Aborted cardiac arrest
timeFrame: Six years
measure: Documented appropriate ICD therapy for ventricular tachycardia
timeFrame: Six years
measure: Documented appropriate ICD therapy for ventricular fibrillation
timeFrame: Six years
Secondary outcomes:
measure: All-cause death(including cardiac death and non-cardiac death)
timeFrame: six years
measure: Heart transplantation
timeFrame: six years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fu Wai Hospital
state: Beijing
Study officials:
affiliation: Fu Wai Hospital
name: Xiaohan Fan, MD,PHD
role: PRINCIPAL_INVESTIGATOR
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