Early Evaluation of Exosome Multiomics and Clinical Prognosis in Patients With Sudden Death

April 6, 2026 updated by: Hao Sun, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with sudden death

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2021

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

February 26, 2025

First Submitted That Met QC Criteria

February 26, 2025

First Posted (Actual)

March 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 8, 2026

Last Update Submitted That Met QC Criteria

April 6, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-SR-320

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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