China Structural Ventricular Arrhythmias Registry

Ventricular Arrythmia Clinical Trial

Official title:

China Structural Ventricular Arrhythmias Registry, a Multicenter，Observational and Prospective Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03821051
• Other study ID #: 2017-950-1
• Status: Recruiting
• 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
• 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:

Related Conditions & MeSH terms

• Ventricular Arrythmia

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