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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Sudden Cardiac Death

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 450

Contacts and Locations

• Study Contact: Name: Lei Song, MD.&phD; Phone Number: 86-13810532620; Email: clinicalfw@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100037
      • Fuwai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Sudden cardiac death and high risk of sudden cardiac death in patients younger than 40 years of age from multiple centers in China between March 1, 2023 and March 1, 2025.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participants with cardiovascular deaths	including sudden cardiac death and deaths due to heart failure and stroke	an average of 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
number of participants with heart failure	progress to level III or IV in New York Heart Association class	an average of 2 years
number of participants with stroke	including cerebral infraction and hemorrhage	an average of 2 years
number of participants with myocardial infarction	including ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction	an average of 2 years

Collaborators and Investigators

• Sponsor: China National Center for Cardiovascular Diseases

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2023
• Primary Completion (ANTICIPATED): March 1, 2025
• Study Completion (ANTICIPATED): March 1, 2026

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (ACTUAL): February 6, 2023

Study Record Updates

• Last Update Posted (ACTUAL): February 6, 2023
• Last Update Submitted That Met QC Criteria: February 1, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Heart Arrest; Death; Death, Sudden, Cardiac
• Other Study ID Numbers: RESCUE-SCD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No