Clinical trial NCT06440083: Pre-warning Risk Scoring System for Sudden Cardiac Death
Official title: Pre-warning Risk Scoring System for Sudden Cardiac Death
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sudden Cardiac Death
Keywords: Sudden Cardiac Death
Cohort study
Lead sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 100000
Sex: ALL
Minimum age (years): 16
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with potential high-risk of sudden cardiac death.

Brief 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.

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.

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.

Primary outcomes:
measure: Sudden cardiac death
timeFrame: Baseline and to the 1-year, 2-year, 5-year follow-up
Secondary outcomes:
measure: All-causes death
timeFrame: Baseline and to the 1-year, 2-year, 5-year follow-up
measure: Recurrence of cardiovascular disease
timeFrame: Baseline and to the 1-year, 2-year, 5-year follow-up
measure: Cardiac arrest
timeFrame: Baseline and to the 1-year, 2-year, 5-year follow-up
measure: Major cardiovascular events
timeFrame: Baseline and to the 1-year, 2-year, 5-year follow-up
Other outcomes:
Locations:
city: Guanzhou
country: China
facility: Sun Yat-sen Memorial Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: Jingfeng Wang, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: