NCT03485079

A Prospective,Multiple Center,Cohort Study of Prediction Model on Sudden Cardiac Death and Devices Development by Automatic Analysis From 24h Electrocardiogram in China

A Prospective, Multiple Center, Cohort Study of Prediction Model on Sudden Cardiac Death and Devices Development by Automatic Analysis From 24h Electrocardiogram in China

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 2,200 (estimated)
• Sponsor: Jingfeng Wang · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Accepted

Summary

This study is a prospective, multicenter, cohort study. The study will be completed in three phases. The first phase aims to establish SCD PW marker and PW score scoring system 1. Use big data processing techniques to find out the differences between survivors with ventricular arrhythmias and normal controls. Find out the SCD Pre-warning ECG Marker (PW marker). 2. Establish SCD Pre-warning risk score system according to traditional SCD risk factors, clinical characteristics of patients and abnormal electrocardiogram indicators. 3. According to the established SCD PW marker and PW score scoring system, the original group of patients are classified and scored. After five years of follow-up with sustained ventricular tachycardia or ventricular fibrillation as the primary end point and sudden cardiac death as the secondary endpoint, Kaplan-Meier are used to calculate the mortality rate of sudden cardiac death and Kaplan-Meier survival analysis. The COX proportional hazards regression model is used to further determine and evaluate the SCD predictive value of PW marker and PW score risk factor scoring system. The second phase is to validate the established PW marker and PW score system models and evaluate the SCD predictive value of it. This stage is divided into two parts: 1. Patients enrolled in traditional high-risk ventricular arrhythmia, will be divided into PW marker positive group and PW marker negative group and join in a 5-year follow-up. Kaplan-Meier is used to calculate the mortality rate of sudden cardiac death and Kaplan-Meier survival analysis is performed to further verify the early warning effect of PW marker on SCD. 2. Patients will be divide into three groups including the low-risk group, middle-risk group and high-risk group according to the PW score risk factor scoring system and join in a 5-year follow-up. Kaplan-Meier is used to calculate the mortality rate of sudden cardiac death, and Kaplan-Meier survival analysis is used to further verify the early warning effect of PW score scoring system on SCD. The third stage is the development stage of SCD early warning equipment. This stage will conduct clinical translational medical studies of PW marker and PW score based on the previous study and develop PW marker and PW score as portable SCD warning device and/or mobile phone APP which will be applied to the clinic for early warning diagnosis of SCD.

Detailed description

This study is a prospective, multicenter, cohort study. The study will be completed in three phases. The first phase is a prospective, multi-center, cohort study of the SCD early warning model. This phase is divided into three parts: 1. Use big data processing techniques to find out the differences between survivors with ventricular arrhythmias and normal controls. Find out the SCD Pre-warning ECG Marker (PW marker), and determine the reasonable threshold of its early warning. 2. Establish SCD Pre-warning risk score system according to traditional SCD risk factors, clinical characteristics of patients and abnormal electrocardiogram indicators. 3. According to the established SCD PW marker and PW score scoring system, the original group of patients are classified and scored. After five years of follow-up with sustained ventricular tachycardia or ventricular fibrillation as the primary end point and sudden cardiac death as the secondary endpoint, Kaplan-Meier are used to calculate the mortality rate of sudden cardiac death and Kaplan-Meier survival analysis. The COX proportional hazards regression model is used to further determine and evaluate the SCD predictive value of PW marker and PW score risk factor scoring system. The second phase is a prospective, multicenter, high-risk cohort study of SCD. It is used to validate the established PW marker and PW score system models and evaluate the SCD predictive value of it. This stage is divided into two parts: 1. Patients enrolled in traditional high-risk ventricular arrhythmia, will be divided into PW marker positive group and PW marker negative group and join in a 5-year follow-up with sustained ventricular tachycardia or ventricular fibrillation as the primary end point and sudden cardiac death as the secondary endpoint. Kaplan-Meier is used to calculate the mortality rate of sudden cardiac death and Kaplan-Meier survival analysis is performed to further verify the early warning effect of PW marker on SCD. 2. Patients will be divide into three groups including the low-risk group, middle-risk group and high-risk group according to the PW score risk factor scoring system and join in a 5-year follow-up with sustained ventricular tachycardia or ventricular fibrillation as the primary end point and sudden cardiac death as the secondary endpoint. Kaplan-Meier is used to calculate the mortality rate of sudden cardiac death, and Kaplan-Meier survival analysis is used to further verify the early warning effect of PW score scoring system on SCD. The third stage is the development stage of SCD early warning equipment. This stage will conduct clinical translational medical studies of PW marker and PW score based on the previous study and develop PW marker and PW score as portable SCD warning device and/or mobile phone APP which will be applied to the clinic for early warning diagnosis of SCD.

Conditions

• Sudden Cardiac Death

Timeline

• Start date: 2018-04-10
• Primary completion: 2022-12-31
• Completion: 2022-12-31
• First posted: 2018-04-02
• Last updated: 2018-04-02

Locations

1 site across 1 country: China