China Inherited Ventricular Arrhythmias Registry

NCT03880708 | Recruiting

• 1 other identifier: 2017-950-2
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Arrythmia

Keywords

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

Outcome Measures

Primary Outcomes (1)

• sustained tachycardia/ ventricular fibrillation or sudden cardiac death

  event of sustained ventricular tachycardia/ ventricular fibrillation or sudden cardiac death

  5 years

Secondary Outcomes (2)

• episodes of arrhythmia

  5 years

• all-cause death

  5 years

Eligibility Criteria

• Age: 1 Hour - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• patients were enrolled by other clinical trials.

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead
• Renmin Hospital of Wuhan University: collaborator
• The First Affiliated Hospital with Nanjing Medical University: collaborator
• Second Affiliated Hospital of Nanchang University: collaborator
• Sir Run Run Shaw Hospital: collaborator
• West China Hospital: collaborator
• Beijing Anzhen Hospital: collaborator
• General Hospital of Shenyang Military Region: collaborator
• Xuzhou Central Hospital: collaborator
• First Affiliated Hospital, Sun Yat-Sen University: collaborator

Study Sites (1)

China National Center for Cardiovascular Diseases

Beijing, Beijing Municipality, 100037, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sample will be collected from enrolled participants to detect biomarkers, like genes, inflammatory factors ,etc.

MeSH Terms

Conditions

Brugada Syndrome; Long QT Syndrome; Short Qt Syndrome; Polymorphic Catecholaminergic Ventricular Tachycardia

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Cardiac Conduction System Disease; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia, Ventricular; Tachycardia

Study Officials

• Yan YAO, MD, PhD

  China National Center for Cardiovascular Diseases

  STUDY CHAIR

Central Study Contacts

Yan YAO, MD,PhD

CONTACT

+86-13901121319; ianyao@263.net.cn

Shangyu LIU, MD

CONTACT

+86-18800161355; liushangyu_yu_fw@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2019
• First Posted: March 19, 2019
• Study Start: October 24, 2017
• Primary Completion: October 24, 2022
• Study Completion (Estimated): October 24, 2027
• Last Updated: March 26, 2019

Record last verified: 2018-10

Locations

CN (1)