China Structural Ventricular Arrhythmias Registry

NCT03821051 | Recruiting

• 1 other identifier: 2017-950-1
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Ventricular Arrythmia

Keywords

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

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

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

In 10 major arrhythmia centers distributed in 6 areas in China, 2000 patients satisfying the inclusion criteria will be enrolled consecutively.

You may qualify if:

• diagnosed as ventricular arrhythmia resulted by structural heart diseases, including ischemic cardiomyopathy, arrhythmogenic right ventricular cardiomyopathy, dilated cardiomyopathy, hypertrophic cardiomyopathy, etc.

You may not qualify if:

• none

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

Arrhythmogenic Right Ventricular Dysplasia; Cardiomyopathy, Dilated; Cardiomyopathy, Hypertrophic

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Cardiomyopathies; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Cardiomegaly; Laminopathies; Genetic Diseases, Inborn; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases

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
• Target Duration: 5 Years
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2019
• First Posted: January 29, 2019
• Study Start: October 24, 2017
• Primary Completion: October 24, 2022
• Study Completion (Estimated): October 24, 2027
• Last Updated: January 29, 2019

Record last verified: 2018-10

Locations

CN (1)