Pre-warning Risk Scoring System for Sudden Cardiac Death

June 3, 2024 updated by: Jingfeng Wang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

The goal of this observational study is to identify potential indicators for pre-warning of sudden cardiac death (SCD), including clinical biochemistry markers, electrocardiogram, echocardiography, MRI and CT imaging values, genetic markers and so on, and further construct a series of multi-parameter assessments of SCD early screening.

Study Overview

Status

Recruiting

Conditions

Sudden Cardiac Death

Detailed Description

In the past few decades, evidence-based drug and surgical treatment strategies have significantly improved the prevention of sudden cardiac death (SCD), however, a large number of patients with cardiovascular disease still face high risk of SCD, the prognosis of these high-risk SCD patients are still uncertain. Therefore, clinical physicians might need to move towards a multi-parameter assessment of SCD risk pre-warning. Several parameters for risk stratification of arrhythmia, including clinical biochemistry markers, electrocardiogram, echocardiography, imaging, and genetic markers, are crucial for accurate assessment of SCD risk stratification. In addition, the integration of cardiac magnetic resonance parameters and specific CT and ECG information is a future research trend for implementing risk stratification of malignant arrhythmias. In order to further explore the possibility of early warning of SCD, this study aims to include subjects with potential SCD risks, collect relevant potential SCD warning indicators, and then construct an SCD prewarning score system. Afterwards, the investigators will continuously improve the SCD warning score system based on follow-up information, and ultimately summarize an effective set of SCD warning scores and apply them to clinical practice, striving to achieve early warning of SCD and benefiting more people at risk of SCD.

Study Type

Observational

Enrollment (Estimated)

100000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Yuling Zhang, M.D.,Ph.D.
Phone Number: +862081332360
Email: zhyul@mail.sysu.edu.cn

Study Contact Backup

Name: Maohuan Lin, M.D.,Ph.D.
Phone Number: +862081332360
Email: lmhuan@mail.sysu.edu.cn

Study Locations

China
- Guangdong
  - Guanzhou, Guangdong, China, 510120
    - Recruiting
    - Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
    - Contact:
      
      Yuling Zhang, Doctor
      
      Phone Number: +862081332360
      
      Email: zhyul@mail.sysu.edu.cn
    - Contact:
      
      Maohuan Lin, Doctor
      
      Phone Number: +862081332360
      
      Email: lmhuan@mail.sysu.edu.cn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants with potential high-risk of sudden cardiac death.

Description

Inclusion Criteria:

The subjects with the following diagnosis of one or more cardiovascular diseases:

Coronary heart disease If there is a history of coronary heart disease or a new diagnosis of coronary heart disease, or with a report of coronary angiography that indicates at least one vascular stenosis>50%. Diagnosis includes chronic coronary syndrome (stable angina, ischemic cardiomyopathy, and occult coronary heart disease) and acute coronary syndrome (unstable angina, ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction).
Heart failure Individuals with a history of heart failure or newly diagnosed heart failure, including heart failure with reduced ejection fraction (HFrEF, left ventricular ejection fraction (LVEF) ≤40%)、intermediate heart failure (HFmrEF, LVEF 41%-49%，with evidence of spontaneous or excitable increase in left ventricular filling pressure), and ejection fraction preserving heart failure (HFpEF, LVEF≥50%, there is evidence of spontaneous or excitable increase in left ventricular filling pressure).
Genetically related cardiomyopathy or arrhythmia Cardiomyopathy includes hypertrophic cardiomyopathy (DCM), dilated cardiomyopathy (HCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), inflammatory cardiomyopathy (myocarditis, sarcoidosis, Chagas disease). Hereditary arrhythmias include long QT syndrome, short QT syndrome, Brugada syndrome, idiopathic ventricular fibrillation, catecholamine sensitive polymorphic ventricular tachycardia (CPVT), early repolarization syndrome, etc.

2) Sign an informed consent form.

Exclusion Criteria:

Age<16 years old;
Refusal to the follow-up visits;
Individuals with severe mental disorders who are unable to express their wishes;
Other obvious physical diseases and abnormal laboratory test results;
Patients deemed unsuitable for participation in this study by the supervising physician.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sudden cardiac death Time Frame: Baseline and to the 1-year, 2-year, 5-year follow-up	Identify participants who die by cardiovascular diseases during follow-up period	Baseline and to the 1-year, 2-year, 5-year follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-causes death Time Frame: Baseline and to the 1-year, 2-year, 5-year follow-up	Identify participants who die during follow-up period	Baseline and to the 1-year, 2-year, 5-year follow-up
Recurrence of cardiovascular disease Time Frame: Baseline and to the 1-year, 2-year, 5-year follow-up	Identify participants who with recurrence of cardiovascular disease during follow-up period	Baseline and to the 1-year, 2-year, 5-year follow-up
Cardiac arrest Time Frame: Baseline and to the 1-year, 2-year, 5-year follow-up	Identify participants who suffer sudden cardiac arrest during follow-up period	Baseline and to the 1-year, 2-year, 5-year follow-up
Major cardiovascular events Time Frame: Baseline and to the 1-year, 2-year, 5-year follow-up	Identify participants who suffer incident major cardiovascular events during follow-up period	Baseline and to the 1-year, 2-year, 5-year follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

Principal Investigator: Jingfeng Wang, M.D.,Ph.D., Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 28, 2024

First Submitted That Met QC Criteria