Identifying risk factors for sudden cardiac death

Pre-warning Risk Scoring System for Sudden Cardiac Death

This study is trying to find warning signs for sudden cardiac death in people with heart conditions by looking at different health tests and markers to help catch risks early.

Quick facts

• Study type: Observational
• Enrollment: 100000 (estimated)
• Ages: 16 Years to 90 Years
• Sex: All
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (other)
• Locations: 1 site (Guanzhou, Guangdong)
• Trial ID: NCT06440083 on ClinicalTrials.gov

What this trial studies

This observational study aims to identify potential indicators for pre-warning of sudden cardiac death (SCD) by evaluating various clinical biochemistry markers, electrocardiogram results, echocardiography, MRI, CT imaging values, and genetic markers. The goal is to construct a multi-parameter assessment system for early screening of SCD risk. By including subjects with cardiovascular diseases, the study will collect relevant data to develop and refine an SCD pre-warning score system, ultimately aiming to improve early detection and prevention strategies for at-risk patients.

Who should consider this trial

Good fit: Ideal candidates include individuals diagnosed with cardiovascular diseases such as coronary heart disease or heart failure.

Not a fit: Patients without any cardiovascular diseases or those who are not at risk for sudden cardiac death may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved early warning systems for sudden cardiac death, potentially saving lives.

How similar studies have performed: While there have been studies focusing on risk factors for sudden cardiac death, this multi-parameter approach is relatively novel and aims to enhance existing methodologies.

Eligibility criteria

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.

Where this trial is running

Guanzhou, Guangdong

• Sun Yat-sen Memorial Hospital of Sun Yat-sen University — Guanzhou, Guangdong, China (RECRUITING)

Study contacts

• Principal investigator: Jingfeng Wang, M.D.,Ph.D. — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Study coordinator: Yuling Zhang, M.D.,Ph.D.

Conditions: Sudden Cardiac Death, Cohort study