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

NCT06856993 | Recruiting

• 1 other identifier: 2021-SR-320
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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).

  2 years

Interventions

standardized medical care of cardiac arrest PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with sudden death

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, 210008, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Death, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart Arrest; Heart Diseases; Cardiovascular Diseases; Death, Sudden; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 26, 2025
• First Posted: March 4, 2025
• Study Start: December 22, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-04

Locations

CN (1)