China Inherited Ventricular Arrhythmias Registry

China Inherited Ventricular Arrhythmias Registry, a Multicenter, Observational and Prospective Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03880708

Enrollment

500

Registered

2019-03-19

Start date

2017-10-24

Completion date

2027-10-24

Last updated

2019-03-26

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

Conditions

Ventricular Arrythmia

Keywords

brugada syndrome, long QT syndrome, short QT syndrome, early repolarization syndrome, catecholaminergic polymorphic ventricular tachycardia

Brief summary

This is an observational, prospective, multi-center registry, aiming at building a risk stratification for malignant inherited ventricular arrhythmias, including Brugada syndrome(Brs)、Long QT syndrome(LQTS)、Short QT syndrome(SQTS)、Early repolarization syndrome(ERS) and Catecholaminergic polymorphic ventricular tachycardia(CPVT). 500 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 related genes and promising risk indicators. The follow-up should be made every 6 months.

Detailed description

In China, the prevalence and risk factors of malignant ventricular arrhythmias remain unclear. In addition, 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 an efficient and economic strategy for early prevention and treatment. Inherited Ventricular Arrhythmias Registry, as a part of China Malignant Ventricular Arrhythmias Study, is an observational, prospective, multi-center registry, aiming at exploring the correlation between genotype and phenotype for inherited structural ventricular arrhythmias, thus helping molecular diagnosis and risk stratification of these conditions. 500 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

Age

1 Hours to 90 Years

Healthy volunteers

Inclusion criteria

* diagnosed as Brugada syndrome(Brs)、Long QT syndrome(LQTS)、Short QT syndrome(SQTS)、Early repolarization syndrome(ERS) or Catecholaminergic polymorphic ventricular tachycardia(CPVT).

Exclusion criteria

* patients were enrolled by other clinical trials.

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	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