China Structural Ventricular Arrhythmias Registry

China Structural Ventricular Arrhythmias Registry, a Multicenter，Observational and Prospective Study.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03821051

Enrollment

2000

Registered

2019-01-29

Start date

2017-10-24

Completion date

2027-10-24

Last updated

2019-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventricular Arrythmia

Keywords

structural ventricular arrythmia, ischemic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, dilated cardiomyopathy, hypertrophic cardiomyopathy, risk stratification

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
sustained tachycardia/ ventricular fibrillation or sudden cardiac death	5 years	event of sustained ventricular tachycardia/ ventricular fibrillation or sudden cardiac death

Secondary

Measure	Time frame	Description
episodes of arrhythmia	5 years	record: type of arrhythmia, the amount of episodes, duration, unstable hemodynamics，treatment，
all-cause death	5 years	exclude accidents, like trauma, drowning.

Countries

China

Contacts

Primary ContactYan Yao, MD,PhD

ianyao@263.net.cn+86-13901121319

Backup ContactShangyu Liu, MD

liushangyu_yu_fw@163.com+86-18800161355

Outcome results