NCT05713240

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
450

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 6, 2023

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

February 6, 2023

Status Verified

February 1, 2023

Enrollment Period

2 years

First QC Date

January 13, 2023

Last Update Submit

February 1, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • number of participants with cardiovascular deaths

    including sudden cardiac death and deaths due to heart failure and stroke

    an average of 2 years

Secondary Outcomes (3)

  • number of participants with heart failure

    an average of 2 years

  • number of participants with stroke

    an average of 2 years

  • number of participants with myocardial infarction

    an average of 2 years

Eligibility Criteria

AgeUp to 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fuwai hospital

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart ArrestHeart DiseasesCardiovascular DiseasesDeath, SuddenDeathPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Lei Song, MD.&phD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

January 13, 2023

First Posted

February 6, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2026

Last Updated

February 6, 2023

Record last verified: 2023-02

Locations