REgiStry in Chinese yoUng pEople With Sudden Cardiac Death

Sudden Cardiac Death Clinical Trial

— RESCUE-SCD  

Official title:

REgiStry in Chinese yoUng pEople With Sudden Cardiac Death（RESCUE-SCD）

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05713240
• Other study ID #: RESCUE-SCD
• Status: Not yet recruiting
• Start date: March 1, 2023
• Est. completion date: March 1, 2026

Study information

• Verified date: February 2023
• Source: China National Center for Cardiovascular Diseases
• Contact: Lei Song, MD.&phD
• Phone: 86-13810532620
• Email: clinicalfw[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The number of sudden cardiac death is up to 540,000 every year in China. Inherited cardiovascular disease is a common cause of sudden cardiac death in young people, and diseases often have the characteristics of family aggregation, so it has a huge psychological and economic burden on family members. Studying the etiology of sudden cardiac death from the molecular level under the model of precision medicine is helpful for screening patients and their relatives so as to further diagnosis, treatment and management, which has important clinical and social significance.

Description:

In this study, sudden cardiac death and high risk of sudden cardiac death in patients younger than 40 years of age are recruited prospectively after informed consent was given. The investigator will collect the baseline clinical characteristics of the patients at enrollment, including comprehensive physical examination, laboratory testing of blood and urine, electrocardiography, 24-hour Holter, echocardiography, MRI and other examinations if necessary. The specimens retained include blood or oral swabs for all patients, and myocardium for patients receiving autopsy. Genetic testing will be performed to identify carried disease genes, genetic risk factors and potential therapy targets.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: March 1, 2026
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 40 Years

Eligibility

Inclusion Criteria:

• Patients with sudden cardiac death and sudden unexplained death diagnosed according current practice guidelines.

• Patients at high risk for sudden cardiac death. (1) Family history of sudden cardiac death at a young age; (2)Successful resuscitation from cardiac arrest; (3) Implantable cardioverter defibrillator implantation after a comprehensive clinical assessment of high risk of sudden cardiac death.

Exclusion Criteria:

• Patients who refuse to sign the informed consent or decline follow-up.

• Patients with sudden death due to car accidents, electric shocks, drowning, fighting, carbon monoxide poisoning and other external causes.

• Patients with sudden death due to other definite causes, such as cerebrovascular accident, severe kidney disease, respiratory disease, neurological disease, etc.

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
China	Fuwai hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China National Center for Cardiovascular Diseases

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of participants with cardiovascular deaths	including sudden cardiac death and deaths due to heart failure and stroke	an average of 2 years
Secondary	number of participants with heart failure	progress to level III or IV in New York Heart Association class	an average of 2 years
Secondary	number of participants with stroke	including cerebral infraction and hemorrhage	an average of 2 years
Secondary	number of participants with myocardial infarction	including ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction	an average of 2 years