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Study on Risk Stratification of Sudden Cardiac Death (SCD) Patients Using High-Frequency QRS Cardiac Holistic Monitoring Technology

Study on Risk Stratification of Sudden Cardiac Death (SCD) Patients Using High-Frequency QRS Cardiac Holistic Monitoring Technology

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500112362
Enrollment
Unknown
Registered
2025-11-13
Start date
2025-11-15
Completion date
Unknown
Last updated
2025-11-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sudden Cardiogenic Death

Interventions

Healthy persons:Acquisition of high frequency QRS waves
Patients at high risk of documented ventricular tachycardia, ventricular fibrillation, or sudden cardiac death:Acquisition of high frequency QRS waves

Sponsors

Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Inclusion Criteria (1) Stage 1: Health examination team 1. Age 18-75 years old; 2. No history of structural heart disease such as coronary heart disease, cardiomyopathy; 3. Signed informed consent. (2) Stage 1 and Stage 2: high-risk groups of ventricular tachycardia, ventricular fibrillation or sudden cardiac death 1. Be over 18 years old. 2. Documented people at high risk of ventricular tachycardia, ventricular fibrillation, or sudden cardiac death meet one of the following criteria: Patients with sustained ventricular tachycardia, ventricular fibrillation, or people at high risk of sudden cardiac death who have recorded (ECG, Holter, bedside and portable ECG monitoring, program-controlled data of implantable devices, including ECG event recorders, ICDs, etc.). 3. People at high risk of sudden cardiac death caused by ventricular fibrillation or hemodynamically unstable sustained ventricular tachycardia caused by non-reversible causes (including patients with ATP and electrical cardioversion with ICD correct electrical therapy). 4. Patients with spontaneous sustained ventricular tachycardia who have been diagnosed with the following organic heart diseases (including patients with ATP and electrical cardioversion with ICD correct electrical therapy). 1) Patients with myocardial infarction for more than 40 days, LVEF 15mm, or symmetrical hypertrophy of the ventricular septum/posterior wall thickness of the left ventricular wall, confirmed by examination (including echocardiography, left ventricular angiography, cardiac MRI or cardiac CT, etc.). <1.3, decreased diastolic compliance of the left ventricle, with or without left ventricular or outflow tract obstruction, cardiac changes caused by hypertension, aortic stenosis and other diseases should be e

Exclusion criteria

Exclusion criteria: Exclusion Criteria: 1. Pregnant or trying to become pregnant. 2. Unable or unwilling to comply with the study protocol and complete follow-up. 3. Have uncontrolled hyperthyroidism and hypothyroidism, severe infection, severe hepatic and renal insufficiency (ALT>= 3 times, or/and eGFR calculated by any formula =40mmHg by UCG or right heart catheterization. 8. Severe electrolyte imbalance, acid-base imbalance. 9. Cardiac arrest caused by various severe bradyarrhythmias. 10. Knowingly allergic reactions to adhesives or hydrogel-based products. 11. Have a recent surgical injury, and the injury site is a part where electrodes may be attached, etc., and electrode bonding and electrocardiogram recording cannot be completed. 12. Is participating in other clinical trials and may affect the data collection of this study. 13. Other conditions that are considered by the investigator to be inappropriate for enrollment.

Design outcomes

Primary

MeasureTime frame
Death;Coronary events;Cerebrovascular events;Heart failure requiring hospitalization;

Secondary

MeasureTime frame
Adverse event rates;

Countries

China

Contacts

Public ContactYuling Zhang

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

zzhangyuling@126.com+86 137 1167 5897

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026