China Inherited Ventricular Arrhythmias Registry

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

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.

Study Overview

• Status: Recruiting
• Conditions: Ventricular Arrythmia

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Recruiting
      • China National Center for Cardiovascular Diseases

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 hour to 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

In 10 major arrhythmia centers distributed in 6 areas in China, 500 patients satisfying the inclusion criteria will be enrolled consecutively

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; General Hospital of Shenyang Military Region; First Affiliated Hospital, Sun Yat-Sen University; West China Hospital; Beijing Anzhen Hospital; Xuzhou Central Hospital; Renmin Hospital of Wuhan University; Sir Run Run Shaw Hospital; Second Affiliated Hospital of Nanchang University
• Investigators: Study Chair: Yan YAO, MD, PhD, China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (Actual): October 24, 2017
• Primary Completion (Anticipated): October 24, 2022
• Study Completion (Anticipated): October 24, 2027

Study Registration Dates

• First Submitted: March 17, 2019
• First Submitted That Met QC Criteria: March 17, 2019
• First Posted (Actual): March 19, 2019

Study Record Updates

• Last Update Posted (Actual): March 26, 2019
• Last Update Submitted That Met QC Criteria: March 22, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: brugada syndrome; long QT syndrome; short QT syndrome; early repolarization syndrome; catecholaminergic polymorphic ventricular tachycardia
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac
• Other Study ID Numbers: 2017-950-2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No