Cardiac Magnetic Resonance for Risk Stratification in Dilated Cardiomyopathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dilated Cardiomyopathy
- Sponsor
- Chinese Academy of Medical Sciences, Fuwai Hospital
- Enrollment
- 2500
- Locations
- 1
- Primary Endpoint
- All-cause Mortality
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
Dilated cardiomyopathy (DCM) is an increasingly recognized cause of morbidity and mortality with heterogenous etiologies (eg, genetic, environment) and clinical manifestations, characterized by left ventricular (LV) systolic dysfunction and LV or biventricular dilation. Previous publications reported the three-year treated mortality rates remain high at 12%-20% and a reported 5-year mortality rate up to 50%, with death resulting from ventricular arrhythmia leading to sudden cardiac death (SCD) or advanced heart failure (HF). With large fields of view and high spatial resolution, Cardiac magnetic resonance (CMR) is the reference standard for assessing cardiac mass, volume, and function. CMR also provides non noninvasive characterization of the myocardium benefiting to differential diagnosis and risk stratification.
Investigators
Minjie Lu
Vice Director of Magnetic Resonance Imaging
Chinese Academy of Medical Sciences, Fuwai Hospital
Eligibility Criteria
Inclusion Criteria
- •reduced left ventricular ejection fraction (LVEF\<50%)
- •LV end-diastolic volume \>2SD from normal according to normograms corrected by body surface area (BSA) and age.
Exclusion Criteria
- •Any evidence indicating the presence of ischemic heart disease:
- •Coronary angiography, perfusion imaging Medical documentation that indicated the presence of ischemic heart disease An infarct pattern of late gadolinium enhancement on cardiac magnetic resonance studies and/or acute coronary syndrome or coronary revascularization during follow-up
- •Any evidence of hypertrophic cardiomyopathy, or moderate-to-severe valvular disease\[18\], or infiltrative disease (such as amyloidosis, sarcoidosis, Fabry disease)
- •Incessant arrhythmias
- •Inability to lie flat
- •Contraindication to cardiac magnetic resonance including severe claustrophobia, defibrillators, pacemakers, certain types of intracranial aneurysm clips, intraocular metal, and Stage IV/V chronic kidney disease
- •Diabetes mellitus with end organ damage
- •Inability to provide informed consent.
Outcomes
Primary Outcomes
All-cause Mortality
Time Frame: 1-10years
the incidence of all-cause death the incidence of all-cause death the incidence of all-cause death the incidence of all-cause mortality
Secondary Outcomes
- A composite of SCD and aborted SCD(1-10years)
- Deterioration of HF(1-10years)
- Major adverse cardiac events(1-10years)