China Structural Ventricular Arrhythmias Registry
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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 |
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Recruitment Status :
Recruiting
First Posted : January 29, 2019
Last Update Posted : January 29, 2019
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| Tracking Information | |||||||||
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| 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 |
sustained tachycardia/ ventricular fibrillation or sudden cardiac death [ Time Frame: 5 years ] event of sustained ventricular tachycardia/ ventricular fibrillation or sudden cardiac death
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures |
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| 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. |
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| Study Type | Observational [Patient Registry] | ||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| 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.
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| 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 | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | Child, Adult, Older Adult | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| 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 |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | China National Center for Cardiovascular Diseases | ||||||||
| Study Sponsor | China National Center for Cardiovascular Diseases | ||||||||
| Collaborators |
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| Investigators |
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| PRS Account | China National Center for Cardiovascular Diseases | ||||||||
| Verification Date | October 2018 | ||||||||