Pre-warning Risk Scoring System for Sudden Cardiac Death

Sudden Cardiac Death Clinical Trial

Official title:

Pre-warning Risk Scoring System for Sudden Cardiac Death

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06440083
• Other study ID #: SYSKY-2023-177-01
• Status: Recruiting
• Start date: March 2, 2023
• Est. completion date: December 31, 2027

Study information

• Verified date: June 2024
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Yuling Zhang, M.D.,Ph.D.
• Phone: +862081332360
• Email: zhyul[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100000
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 90 Years

Eligibility

Inclusion Criteria:

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

1. 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).

2. 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).

3. 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:

1. Age<16 years old;

2. Refusal to the follow-up visits;

3. Individuals with severe mental disorders who are unable to express their wishes;

4. Other obvious physical diseases and abnormal laboratory test results;

5. Patients deemed unsuitable for participation in this study by the supervising physician.

Related Conditions & MeSH terms

• Death
• Death, Sudden, Cardiac
• Sudden Cardiac Death

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Guanzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sudden cardiac death	Identify participants who die by cardiovascular diseases during follow-up period	Baseline and to the 1-year, 2-year, 5-year follow-up
Secondary	All-causes death	Identify participants who die during follow-up period	Baseline and to the 1-year, 2-year, 5-year follow-up
Secondary	Recurrence of cardiovascular disease	Identify participants who with recurrence of cardiovascular disease during follow-up period	Baseline and to the 1-year, 2-year, 5-year follow-up
Secondary	Cardiac arrest	Identify participants who suffer sudden cardiac arrest during follow-up period	Baseline and to the 1-year, 2-year, 5-year follow-up
Secondary	Major cardiovascular events	Identify participants who suffer incident major cardiovascular events during follow-up period	Baseline and to the 1-year, 2-year, 5-year follow-up