China Structural Ventricular Arrhythmias Registry
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03821051|
Recruitment Status : Recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
|Condition or disease|
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]|
|Estimated Enrollment :||2000 participants|
|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|
- sustained tachycardia/ ventricular fibrillation or sudden cardiac death [ Time Frame: 5 years ]event of sustained ventricular tachycardia/ ventricular fibrillation or sudden cardiac death
- 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.
Biospecimen Retention: Samples With DNA
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
|Contact: Yan Yao, MD,PhDfirstname.lastname@example.org|
|Contact: Shangyu Liu, MDemail@example.com|
|Study Chair:||Yan Yao, MD,PhD||China National Center for Cardiovascular Diseases|