China Inherited Ventricular Arrhythmias Registry

NCT ID: NCT03880708

Last Updated: 2019-03-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-24

Study Completion Date

2027-10-24

Brief Summary

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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

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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.

Conditions

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Ventricular Arrythmia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Hour

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Renmin Hospital of Wuhan University

OTHER

Sponsor Role collaborator

The First Affiliated Hospital with Nanjing Medical University

OTHER

Sponsor Role collaborator

Second Affiliated Hospital of Nanchang University

OTHER

Sponsor Role collaborator

Sir Run Run Shaw Hospital

OTHER

Sponsor Role collaborator

West China Hospital

OTHER

Sponsor Role collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

General Hospital of Shenyang Military Region

OTHER

Sponsor Role collaborator

Xuzhou Central Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital, Sun Yat-Sen University

OTHER

Sponsor Role collaborator

China National Center for Cardiovascular Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yan YAO, MD, PhD

Role: STUDY_CHAIR

China National Center for Cardiovascular Diseases

Locations

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China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yan YAO, MD,PhD

Role: CONTACT

+86-13901121319

Shangyu LIU, MD

Role: CONTACT

+86-18800161355

Facility Contacts

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Yan YAO, MD, PhD

Role: primary

+86-13901121319

Shangyu LIU, MD

Role: backup

+86-18800161355

Other Identifiers

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2017-950-2

Identifier Type: -

Identifier Source: org_study_id

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