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China Structural Ventricular Arrhythmias Registry

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ClinicalTrials.gov Identifier: NCT03821051
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
Sponsor:
Collaborators:
Renmin Hospital of Wuhan University
The First Affiliated Hospital with Nanjing Medical University
Second Affiliated Hospital of Nanchang University
Sir Run Run Shaw Hospital
West China Hospital
Beijing Anzhen Hospital
General Hospital of Shenyang Military Region
Xuzhou Central Hospital
First Affiliated Hospital, Sun Yat-Sen University
Information provided by (Responsible Party):
China National Center for Cardiovascular Diseases

Tracking Information
First Submitted Date January 27, 2019
First Posted Date January 29, 2019
Last Update Posted Date January 29, 2019
Actual Study Start Date October 24, 2017
Estimated Primary Completion Date October 24, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 27, 2019)
sustained tachycardia/ ventricular fibrillation or sudden cardiac death [ Time Frame: 5 years ]
event of sustained ventricular tachycardia/ ventricular fibrillation or sudden cardiac death
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 27, 2019)
  • episodes of arrhythmia [ Time Frame: 5 years ]
    record: type of arrhythmia, the amount of episodes, duration, unstable hemodynamics,treatment,
  • all-cause death [ Time Frame: 5 years ]
    exclude accidents, like trauma, drowning.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title China Structural Ventricular Arrhythmias Registry
Official Title China Structural Ventricular Arrhythmias Registry, a Multicenter,Observational and Prospective Study.
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.
Detailed 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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 5 Years
Biospecimen Retention:   Samples With DNA
Description:
blood sample will be collected from enrolled participants to detect biomarkers, like genes, inflammatory factors ,etc.
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.
Condition Ventricular Arrythmia
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 27, 2019)
2000
Original Estimated Enrollment Same as current
Estimated Study Completion Date October 24, 2027
Estimated Primary Completion Date October 24, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

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:

  • none
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Yan Yao, MD,PhD +86-13901121319 ianyao@263.net.cn
Contact: Shangyu Liu, MD +86-18800161355 liushangyu_yu_fw@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03821051
Other Study ID Numbers 2017-950-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party China National Center for Cardiovascular Diseases
Study Sponsor China National Center for Cardiovascular Diseases
Collaborators
  • Renmin Hospital of Wuhan University
  • The First Affiliated Hospital with Nanjing Medical University
  • Second Affiliated Hospital of Nanchang University
  • Sir Run Run Shaw Hospital
  • West China Hospital
  • Beijing Anzhen Hospital
  • General Hospital of Shenyang Military Region
  • Xuzhou Central Hospital
  • First Affiliated Hospital, Sun Yat-Sen University
Investigators
Study Chair: Yan Yao, MD,PhD China National Center for Cardiovascular Diseases
PRS Account China National Center for Cardiovascular Diseases
Verification Date October 2018