Clinical trial NCT03821051: China Structural Ventricular Arrhythmias Registry
Official title: China Structural Ventricular Arrhythmias Registry, a Multicenter，Observational and Prospective Study.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ventricular Arrythmia
Keywords: structural ventricular arrythmia
ischemic cardiomyopathy
arrhythmogenic right ventricular cardiomyopathy
dilated cardiomyopathy
hypertrophic cardiomyopathy
risk stratification
Lead sponsor: China National Center for Cardiovascular Diseases
Sponsor class: OTHER_GOV
Collaborators: name: Renmin Hospital of Wuhan University
name: The First Affiliated Hospital with Nanjing Medical University
name: Second Affiliated Hospital of Nanchang University
name: Sir Run Run Shaw Hospital
name: West China Hospital
name: Beijing Anzhen Hospital
name: General Hospital of Shenyang Military Region
name: Xuzhou Central Hospital
name: First Affiliated Hospital, Sun Yat-Sen University
First posted: 2019-01-29
Enrollment: 2000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In 10 major arrhythmia centers distributed in 6 areas in China, 2000 patients satisfying the inclusion criteria will be enrolled consecutively.

Brief summary: This is an observational, prospective, multi-center registry ,aiming at building a risk stratification for malignant structural ventricular arrhythmias. 2000 participants will be recruited from 10 centers in China,with clinical data to be abstracted from medical records ,and blood samples to be collected for finding promising risk indicators.The follow-up should be made every 6 mouths.

Detailed description: In China, the prevalence and risk factors of malignant ventricular arrhythmias remain unclear. In addition ,the mainstream treatment relies on implantable devices and medication.China Malignant Ventricular Arrhythmias Study is a nation-wide complex consisting of several interrelated studies, with the aim of building a risk stratification as well as a efficient and economic strategy for early prevention and treatment.

Structural Ventricular Arrhythmias Registry, as a part of China Malignant Ventricular Arrhythmias Study, is an observational, prospective, multi-center registry, aiming at building a risk stratification for malignant structural ventricular arrhythmias. 2000 patients with definitive diagnosis will be recruited consecutively from 10 major arrhythmia centers distributed in 6 areas in China. At study entry, participants will be interviewed and asked to sign the informed consent. Demographic characteristics, medical history, clinical features, laboratory tests, imaging pictures, medications, procedures, and in-hospital outcomes of patients will be abstracted from medical records by well trained staffs .At the same time, blood samples will be collected to detect biological markers, like genes, inflammatory factors ,etc. Once enrolled, the participants will receive follow up every 6 mouths about condition of arrhythmia, medication, clinical events, etc.

Eligibility criteria: Inclusion Criteria:

* diagnosed as ventricular arrhythmia resulted by structural heart diseases, including ischemic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, dilated cardiomyopathy, hypertrophic cardiomyopathy, etc.

Exclusion Criteria:

* none

Primary outcomes:
measure: sustained tachycardia/ ventricular fibrillation or sudden cardiac death
timeFrame: 5 years
Secondary outcomes:
measure: episodes of arrhythmia
timeFrame: 5 years
measure: all-cause death
timeFrame: 5 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: China National Center for Cardiovascular Diseases
state: Beijing
Study officials:
affiliation: China National Center for Cardiovascular Diseases
name: Yan Yao, MD,PhD
role: STUDY_CHAIR
References: