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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

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.

Condition or disease
Ventricular Arrythmia

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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: China Structural Ventricular Arrhythmias Registry, a Multicenter,Observational and Prospective Study.
Actual Study Start Date : October 24, 2017
Estimated Primary Completion Date : October 24, 2022
Estimated Study Completion Date : October 24, 2027





Primary Outcome Measures :
  1. sustained tachycardia/ ventricular fibrillation or sudden cardiac death [ Time Frame: 5 years ]
    event of sustained ventricular tachycardia/ ventricular fibrillation or sudden cardiac death


Secondary Outcome Measures :
  1. episodes of arrhythmia [ Time Frame: 5 years ]
    record: type of arrhythmia, the amount of episodes, duration, unstable hemodynamics,treatment,

  2. all-cause death [ Time Frame: 5 years ]
    exclude accidents, like trauma, drowning.


Biospecimen Retention:   Samples With DNA
blood sample will be collected from enrolled participants to detect biomarkers, like genes, inflammatory factors ,etc.


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03821051


Contacts
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Contact: Yan Yao, MD,PhD +86-13901121319 ianyao@263.net.cn
Contact: Shangyu Liu, MD +86-18800161355 liushangyu_yu_fw@163.com

Locations
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China, Beijing
China National Center for Cardiovascular Diseases Recruiting
Beijing, Beijing, China, 100037
Contact: Yan Yao, MD, PhD    +86-13901121319    ianyao@263.net.cn   
Contact: Shangyu Liu, MD    +86-18800161355    liushangyu_fw@163.com   
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
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
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Study Chair: Yan Yao, MD,PhD China National Center for Cardiovascular Diseases
Additional Information:

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Responsible Party: China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT03821051    
Other Study ID Numbers: 2017-950-1
First Posted: January 29, 2019    Key Record Dates
Last Update Posted: January 29, 2019
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by China National Center for Cardiovascular Diseases:
structural ventricular arrythmia
ischemic cardiomyopathy
arrhythmogenic right ventricular cardiomyopathy
dilated cardiomyopathy
hypertrophic cardiomyopathy
risk stratification
Additional relevant MeSH terms:
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Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes