Pre-warning Risk Scoring System for Sudden Cardiac Death

NCT06440083 | Recruiting

• 1 other identifier: SYSKY-2023-177-01
• Study Type: observational
• Target: 100,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Sudden Cardiac Death

Keywords

Sudden Cardiac Death; Cohort study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• All-causes death

  Baseline and to the 1-year, 2-year, 5-year follow-up

• Recurrence of cardiovascular disease

  Baseline and to the 1-year, 2-year, 5-year follow-up

• Cardiac arrest

  Baseline and to the 1-year, 2-year, 5-year follow-up

• Major cardiovascular events

  Baseline and to the 1-year, 2-year, 5-year follow-up

Eligibility Criteria

• Age: 16 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with potential high-risk of sudden cardiac death.

You may qualify if:

• 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.
• \) Sign an informed consent form.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guanzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jingfeng Wang, M.D.,Ph.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuling Zhang, M.D.,Ph.D.

CONTACT

+862081332360; zhyul@mail.sysu.edu.cn

Maohuan Lin, M.D.,Ph.D.

CONTACT

+862081332360; lmhuan@mail.sysu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 3, 2024
• Study Start: March 2, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: June 5, 2024

Record last verified: 2024-06

Locations

CN (1)