Sudden Cardiac DeathNCT06440083
Pre-warning Risk Scoring System for Sudden Cardiac Death
An observational study of Sudden Cardiac Death, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
The goal of this observational study is to identify potential indicators for pre-warning of sudden cardiac death (SCD), including clinical biochemistry markers, electrocardiogram, echocardiography, MRI and CT imaging values, genetic markers and so on, and further construct a series of multi-parameter assessments of… Read more about this study
- Who is it for?
- Ages 16 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Sudden Cardiac Death
- How many people
- 100,000 participants
- Where
- 1 siteChina
- Study dates
- 2 Mar 2023to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 16 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Participants with potential high-risk of sudden cardiac death.
Who may be able to join
- The subjects with the following diagnosis of one or more cardiovascular diseases:
- Coronary heart disease If there is a history of coronary heart disease or a new diagnosis of coronary heart disease, or with a report of coronary angiography that indicates at least one vascular stenosis>50%. Diagnosis includes chronic coronary syndrome (stable angina, ischemic cardiomyopathy, and occult coronary heart disease) and acute coronary syndrome (unstable angina, ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction).
- Heart failure Individuals with a history of heart failure or newly diagnosed heart failure, including heart failure with reduced ejection fraction (HFrEF, left ventricular ejection fraction (LVEF) ≤40%)、intermediate heart failure (HFmrEF, LVEF 41%-49%，with evidence of spontaneous or excitable increase in left ventricular filling pressure), and ejection fraction preserving heart failure (HFpEF, LVEF≥50%, there is evidence of spontaneous or excitable increase in left ventricular filling pressure).
- Genetically related cardiomyopathy or arrhythmia Cardiomyopathy includes hypertrophic cardiomyopathy (DCM), dilated cardiomyopathy (HCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), inflammatory cardiomyopathy (myocarditis, sarcoidosis, Chagas disease). Hereditary arrhythmias include long QT syndrome, short QT syndrome, Brugada syndrome, idiopathic ventricular fibrillation, catecholamine sensitive polymorphic ventricular tachycardia (CPVT), early repolarization syndrome, etc.
- 2) Sign an informed consent form.
Who cannot join
- Age<16 years old;
- Refusal to the follow-up visits;
- Individuals with severe mental disorders who are unable to express their wishes;
- Other obvious physical diseases and abnormal laboratory test results;
- Patients deemed unsuitable for participation in this study by the supervising physician.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guanzhou, Guangdong, 510120
Yuling Zhang, Doctor, +862081332360, zhyul@mail.sysu.edu.cn
Maohuan Lin, Doctor, +862081332360, lmhuan@mail.sysu.edu.cn
About this study
The goal of this observational study is to identify potential indicators for pre-warning of sudden cardiac death (SCD), including clinical biochemistry markers, electrocardiogram, echocardiography, MRI and CT imaging values, genetic markers and so on, and further construct a series of multi-parameter assessments of SCD early screening.
Read the detailed description
In the past few decades, evidence-based drug and surgical treatment strategies have significantly improved the prevention of sudden cardiac death (SCD), however, a large number of patients with cardiovascular disease still face high risk of SCD, the prognosis of these high-risk SCD patients are still uncertain. Therefore, clinical physicians might need to move towards a multi-parameter assessment of SCD risk pre-warning. Several parameters for risk stratification of arrhythmia, including clinical biochemistry markers, electrocardiogram, echocardiography, imaging, and genetic markers, are crucial for accurate assessment of SCD risk stratification. In addition, the integration of cardiac magnetic resonance parameters and specific CT and ECG information is a future research trend for implementing risk stratification of malignant arrhythmias. In order to further explore the possibility of early warning of SCD, this study aims to include subjects with potential SCD risks, collect relevant potential SCD warning indicators, and then construct an SCD prewarning score system. Afterwards, the investigators will continuously improve the SCD warning score system based on follow-up information, and ultimately summarize an effective set of SCD warning scores and apply them to clinical practice, striving to achieve early warning of SCD and benefiting more people at risk of SCD.
- Conditions
- Sudden Cardiac Death
- Keywords
- Sudden Cardiac Death, Cohort study
- Medical subject headings
- Death, Sudden, Cardiac
What is being measured
The primary outcome is the main question the study is designed to answer.
Sudden cardiac death
Identify participants who die by cardiovascular diseases during follow-up period
Measured: Baseline and to the 1-year, 2-year, 5-year follow-up
Secondary outcomes (4)
All-causes death
Identify participants who die during follow-up period
Measured: Baseline and to the 1-year, 2-year, 5-year follow-up
Recurrence of cardiovascular disease
Identify participants who with recurrence of cardiovascular disease during follow-up period
Measured: Baseline and to the 1-year, 2-year, 5-year follow-up
Cardiac arrest
Identify participants who suffer sudden cardiac arrest during follow-up period
Measured: Baseline and to the 1-year, 2-year, 5-year follow-up
Major cardiovascular events
Identify participants who suffer incident major cardiovascular events during follow-up period
Measured: Baseline and to the 1-year, 2-year, 5-year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2024
- Study start2 Mar 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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.
- 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
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jingfeng Wang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Jingfeng Wang, M.D.,Ph.D., Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06440083
- Sponsor's protocol ID
- SYSKY-2023-177-01
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 5 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-warning Risk Scoring System for Sudden Cardiac Death
- ClinicalTrials.gov ID
- NCT06440083
- Acronym / sponsor ID
- SYSKY-2023-177-01
- Conditions
- Sudden Cardiac Death
- Keywords
- Sudden Cardiac Death, Cohort study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 2 Mar 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 3 Jun 2024 (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 goal of this observational study is to identify potential indicators for pre-warning of sudden cardiac death (SCD), including clinical biochemistry markers, electrocardiogram, echocardiography, MRI and CT imaging values, genetic markers and so on, and further construct a series of multi-parameter assessments of SCD early screening.
Detailed description
In the past few decades, evidence-based drug and surgical treatment strategies have significantly improved the prevention of sudden cardiac death (SCD), however, a large number of patients with cardiovascular disease still face high risk of SCD, the prognosis of these high-risk SCD patients are still uncertain. Therefore, clinical physicians might need to move towards a multi-parameter assessment of SCD risk pre-warning. Several parameters for risk stratification of arrhythmia, including clinical biochemistry markers, electrocardiogram, echocardiography, imaging, and genetic markers, are crucial for accurate assessment of SCD risk stratification. In addition, the integration of cardiac magnetic resonance parameters and specific CT and ECG information is a future research trend for implementing risk stratification of malignant arrhythmias. In order to further explore the possibility of early warning of SCD, this study aims to include subjects with potential SCD risks, collect relevant potential SCD warning indicators, and then construct an SCD prewarning score system. Afterwards, the investigators will continuously improve the SCD warning score system based on follow-up information, and ultimately summarize an effective set of SCD warning scores and apply them to clinical practice, striving to achieve early warning of SCD and benefiting more people at risk of SCD.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants with potential high-risk of sudden cardiac death.
Key inclusion criteria (5 listed)
- Coronary heart disease If there is a history of coronary heart disease or a new diagnosis of coronary heart disease, or with a report of coronary angiography that indicates at least one vascular stenosis>50%. Diagnosis includes chronic coronary syndrome (stable angina, ischemic cardiomyopathy, and occult coronary heart disease) and acute coronary syndrome (unstable angina, ST-segment elevation myocardial infarction and non-ST-segment elevation myocardial infarction).
- Heart failure Individuals with a history of heart failure or newly diagnosed heart failure, including heart failure with reduced ejection fraction (HFrEF, left ventricular ejection fraction (LVEF) ≤40%)、intermediate heart failure (HFmrEF, LVEF 41%-49%，with evidence of spontaneous or excitable increase in left ventricular filling pressure), and ejection fraction preserving heart failure (HFpEF, LVEF≥50%, there is evidence of spontaneous or excitable increase in left ventricular filling pressure).
- Genetically related cardiomyopathy or arrhythmia Cardiomyopathy includes hypertrophic cardiomyopathy (DCM), dilated cardiomyopathy (HCM), arrhythmogenic right ventricular cardiomyopathy (ARVC), inflammatory cardiomyopathy (myocarditis, sarcoidosis, Chagas disease). Hereditary arrhythmias include long QT syndrome, short QT syndrome, Brugada syndrome, idiopathic ventricular fibrillation, catecholamine sensitive polymorphic ventricular tachycardia (CPVT), early repolarization syndrome, etc.
- 2) Sign an informed consent form.
Key exclusion criteria (5 listed)
- Age<16 years old;
- Refusal to the follow-up visits;
- Individuals with severe mental disorders who are unable to express their wishes;
- Other obvious physical diseases and abnormal laboratory test results;
- Patients deemed unsuitable for participation in this study by the supervising physician.
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
Sudden cardiac death
Time frame: Baseline and to the 1-year, 2-year, 5-year follow-up
Identify participants who die by cardiovascular diseases during follow-up period
4 secondary outcomes
All-causes death
Time frame: Baseline and to the 1-year, 2-year, 5-year follow-up
Recurrence of cardiovascular disease
Time frame: Baseline and to the 1-year, 2-year, 5-year follow-up
Cardiac arrest
Time frame: Baseline and to the 1-year, 2-year, 5-year follow-up
Major cardiovascular events
Time frame: Baseline and to the 1-year, 2-year, 5-year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2024.
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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.
Jingfeng Wang, M.D.,Ph.D. principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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 Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 5 Jun 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuling Zhang, M.D.,Ph.D. (+862081332360, zhyul@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sudden cardiac death (time frame: Baseline and to the 1-year, 2-year, 5-year follow-up). 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 5 Jun 2024.