Sudden Cardiac DeathRESCUE-SCDNCT05713240
REgiStry in Chinese yoUng pEople With Sudden Cardiac Death
An observational study of Sudden Cardiac Death, run by China National Center for Cardiovascular Diseases at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages Up to 40 years
- Conditions the study is for
- Sudden Cardiac Death
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2023to 1 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Sudden Cardiac Death
- Medical subject headings
- Death, Sudden, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
number of participants with cardiovascular deaths
including sudden cardiac death and deaths due to heart failure and stroke
Measured: an average of 2 years
Secondary outcomes (3)
number of participants with heart failure
progress to level III or IV in New York Heart Association class
Measured: an average of 2 years
number of participants with stroke
including cerebral infraction and hemorrhage
Measured: an average of 2 years
number of participants with myocardial infarction
including ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction
Measured: an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2023
- Study start1 Mar 2023 (estimated)
- Primary completion1 Mar 2025 (estimated)
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sudden Cardiac DeathStudies of the same condition, open and under way.
- More trials run by China National Center for Cardiovascular DiseasesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Lei.Song,MD.&ph.D, China National Center for Cardiovascular Diseases
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05713240
- Sponsor's protocol ID
- RESCUE-SCD
- Acronym
- RESCUE-SCD
- Status last verified
- Feb 2023
- First submitted
- 13 Jan 2023
- Last updated
- 6 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- REgiStry in Chinese yoUng pEople With Sudden Cardiac Death（RESCUE-SCD）
- ClinicalTrials.gov ID
- NCT05713240
- Acronym / sponsor ID
- RESCUE-SCD / RESCUE-SCD
- Conditions
- Sudden Cardiac Death
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- China National Center for Cardiovascular DiseasesOther government
- Study start
- 1 Mar 2023 (estimated)
- Primary completion
- 1 Mar 2025 (estimated)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 6 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
number of participants with cardiovascular deaths
Time frame: an average of 2 years
including sudden cardiac death and deaths due to heart failure and stroke
3 secondary outcomes
number of participants with heart failure
Time frame: an average of 2 years
number of participants with stroke
Time frame: an average of 2 years
number of participants with myocardial infarction
Time frame: an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sudden Cardiac Death, run by China National Center for Cardiovascular Diseases at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Song, MD.&phD (86-13810532620, clinicalfw@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of participants with cardiovascular deaths (time frame: an average of 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2023.