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