Sudden Cardiac DeathNCT06856993
Early Evaluation of Exosome Multiomics and Clinical Prognosis in Patients With Sudden Death
An observational study of Sudden Cardiac Death and Exosome Multiomics, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Acute coronary syndrome (ACS) is one of the main causes of death. Worldwide, tens of millions of patients are hospitalized for coronary heart disease and ACS every year. ACS may show acute myocardial infarction, unstable angina pectoris, and even induce early arrhythmia, leading to sudden death. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sudden Cardiac Death, Exosome Multiomics, Clinical Prognosis
- What is being tested?
- standardized medical care of cardiac arrest
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- 22 Dec 2021to 31 Dec 2027
- How long will I take part?
- 3 Months
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with sudden death
Who may be able to join
- The death event happens suddenly.
- Age ≥ 18 years
- The patient had obvious clinical symptoms 24 hours before treatment
- Life expectancy exceeds 3 days
- Proxy of patients signs the informed consent form
- Comply with ACS diagnostic indicators recommended by ACC / AHA guidelines in 2016
Who cannot join
- Death caused by accident, such as trauma, poisoning, etc.
- Death from accidental or intentional overdose
- Death from asphyxia
- Death is caused by chronic disease or terminal illness
- The patient died naturally
- Has participated in other clinical studies
- Immediate family members give up continuing treatment
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
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Hao Sun, MD, 8613584017821, haosun_6@163.com
About this study
Acute coronary syndrome (ACS) is one of the main causes of death. Worldwide, tens of millions of patients are hospitalized for coronary heart disease and ACS every year. ACS may show acute myocardial infarction, unstable angina pectoris, and even induce early arrhythmia, leading to sudden death. Sudden cardiac death (SCD) has a strong correlation with ACS. Data from clinical and autopsy studies and death certificates show that 62-85% of patients with out of hospital SCD have a history of ACS, 10% have other cardiac structural abnormalities, and 5% have no cardiac structural abnormalities. An SCD surveillance study from Ireland concluded that most cases occurred in families, and the successful recovery of SCD was mainly related to ventricular fibrillation with arrhythmia. At present, there are few reports on the clinical and prognosis of ACS in China, and there is no guideline or consensus on the prevention and treatment of ACS patients. Known domestic research results show that the proportion of male, overweight / obese, smokers in young ACS patients is higher than that in the elderly group, while the proportion of patients with hypertension, diabetes and cerebrovascular diseases is less than that of the elderly group. The levels of TC, TG, LDL-C and UA and the proportion of low HDL-C in young ACS patients were higher than those in elderly patients; The diagnosis of STEMI was the highest in the young ACS group, while the diagnosis of unstable angina pectoris was the most common in the elderly ACS group. The clinical manifestations of ACS vary greatly. 3% ~ 5% of patients who exclude ACS only through myocardial markers, clinical blood transfusion and ECG still have myocardial infarction (MI). For the emergency department, early prediction of the risk of SCD in ACS patients and timely and accurate screening of high-risk patients are very important.
- Conditions
- Sudden Cardiac Death, Exosome Multiomics, Clinical Prognosis
- Being tested
- standardized medical care of cardiac arrest
- Medical subject headings
- Death, Sudden, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
standardized medical care of cardiac arrestProcedure or surgery
The standardized medical care for cardiac arrest includes early cardiopulmonary resuscitation (CPR), defibrillation, advanced cardiac life support (ACLS), post-resuscitation care, and continuous monitoring of the patient's vital functions.
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence (or not of exosome-associated metabolites, microRNAs, and proteins
This outcome measure evaluates the presence (or not) of specific exosome-associated biomolecules, including metabolites (pyruvate, spermidine, glycine, glucose, L-phenylalanine), microRNAs (microRNA-208b-3p, microRNA-143-3p), and proteins (PSMB10, A1BG).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2025
- Study start22 Dec 2021
- Primary completion31 Dec 2026 (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.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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
- 300 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Sun, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06856993
- Sponsor's protocol ID
- 2021-SR-320
- Status last verified
- Apr 2026
- First submitted
- 26 Feb 2025
- Last updated
- 8 Apr 2026
- 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 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Evaluation of Exosome Multiomics and Clinical Prognosis in Patients With Sudden Death
- ClinicalTrials.gov ID
- NCT06856993
- Acronym / sponsor ID
- 2021-SR-320
- Conditions
- Sudden Cardiac Death, Exosome Multiomics, Clinical Prognosis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 22 Dec 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 4 Mar 2025 (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.
Acute coronary syndrome (ACS) is one of the main causes of death. Worldwide, tens of millions of patients are hospitalized for coronary heart disease and ACS every year. ACS may show acute myocardial infarction, unstable angina pectoris, and even induce early arrhythmia, leading to sudden death. Sudden cardiac death (SCD) has a strong correlation with ACS. Data from clinical and autopsy studies and death certificates show that 62-85% of patients with out of hospital SCD have a history of ACS, 10% have other cardiac structural abnormalities, and 5% have no cardiac structural abnormalities. An SCD surveillance study from Ireland concluded that most cases occurred in families, and the successful recovery of SCD was mainly related to ventricular fibrillation with arrhythmia. At present, there are few reports on the clinical and prognosis of ACS in China, and there is no guideline or consensus on the prevention and treatment of ACS patients. Known domestic research results show that the proportion of male, overweight / obese, smokers in young ACS patients is higher than that in the elderly group, while the proportion of patients with hypertension, diabetes and cerebrovascular diseases is less than that of the elderly group. The levels of TC, TG, LDL-C and UA and the proportion of low HDL-C in young ACS patients were higher than those in elderly patients; The diagnosis of STEMI was the highest in the young ACS group, while the diagnosis of unstable angina pectoris was the most common in the elderly ACS group. The clinical manifestations of ACS vary greatly. 3% ~ 5% of patients who exclude ACS only through myocardial markers, clinical blood transfusion and ECG still have myocardial infarction (MI). For the emergency department, early prediction of the risk of SCD in ACS patients and timely and accurate screening of high-risk patients are very important.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with sudden death
Key inclusion criteria (6 listed)
- The death event happens suddenly.
- Age ≥ 18 years
- The patient had obvious clinical symptoms 24 hours before treatment
- Life expectancy exceeds 3 days
- Proxy of patients signs the informed consent form
Key exclusion criteria (7 listed)
- Death caused by accident, such as trauma, poisoning, etc.
- Death from accidental or intentional overdose
- Death from asphyxia
- Death is caused by chronic disease or terminal illness
- The patient died naturally
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| standardized medical care of cardiac arrestThe standardized medical care for cardiac arrest includes early cardiopulmonary resuscitation (CPR), defibrillation, advanced cardiac life support (ACLS), post-resuscitation care, and continuous monitoring of the patient's vital functions. | Procedure or surgery | – |
Primary outcome
Presence (or not of exosome-associated metabolites, microRNAs, and proteins
Time frame: 2 years
This outcome measure evaluates the presence (or not) of specific exosome-associated biomolecules, including metabolites (pyruvate, spermidine, glycine, glucose, L-phenylalanine), microRNAs (microRNA-208b-3p, microRNA-143-3p), and proteins (PSMB10, A1BG).
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 8 Apr 2026.
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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.
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 and Exosome Multiomics, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 6 inclusion and 7 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 8 Apr 2026. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence (or not of exosome-associated metabolites, microRNAs, and proteins (time frame: 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 8 Apr 2026.