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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03821051
Other study ID # 2017-950-1
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 24, 2017
Est. completion date October 24, 2027

Study information

Verified date October 2018
Source China National Center for Cardiovascular Diseases
Contact Yan Yao, MD,PhD
Phone +86-13901121319
Email ianyao@263.net.cn
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Description:

In China, the prevalence and risk factors of malignant ventricular arrhythmias remain unclear. In addition ,the 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 a efficient and economic strategy for early prevention and treatment.

Structural Ventricular Arrhythmias Registry, as a part of China Malignant Ventricular Arrhythmias Study, is an observational, prospective, multi-center registry, aiming at building a risk stratification for malignant structural ventricular arrhythmias. 2000 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date October 24, 2027
Est. primary completion date October 24, 2022
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
China China National Center for Cardiovascular Diseases Beijing Beijing

Sponsors (10)

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

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary sustained tachycardia/ ventricular fibrillation or sudden cardiac death event of sustained ventricular tachycardia/ ventricular fibrillation or sudden cardiac death 5 years
Secondary episodes of arrhythmia record: type of arrhythmia, the amount of episodes, duration, unstable hemodynamics,treatment, 5 years
Secondary all-cause death exclude accidents, like trauma, drowning. 5 years
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