跳至主要内容
临床试验/NCT06856993
NCT06856993招募中不适用

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

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年12月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
Presence (or not of exosome-associated metabolites, microRNAs, and proteins

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Presence (or not of exosome-associated metabolites, microRNAs, and proteins

时间窗: 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).

次要结局

未报告次要终点

研究者

发起方
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hao Sun

MD

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

研究点 (1)

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