跳至主要内容
临床试验/NCT06316011
NCT06316011招募中不适用

Magnetocardiography in the Identification and Risk Stratification of Patients With Acute Chest Pian

Qilu Hospital of Shandong University1 个研究点 分布在 1 个国家目标入组 3,620 人开始时间: 2024年3月20日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
3,620
试验地点
1
主要终点
Efficacy of MCG for the detection and risk stratification in high-risk patients with chest pain

研究概览

简要总结

This prospective cohort study is aimed at identification and risk stratification of patients who have symptoms of acute chest pain suspected with acute coronary syndrome (ACS) using Magnetocardiography (MCG).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Those with suspected ACS who presented with symptoms of acute chest pain.
  • Signed informed consent.

排除标准

  • Those with known structural heart disease such as cardiomyopathy and valvular disease;
  • Those with atrial fibrillation, supraventricular tachycardia, atrioventricular block and other arrhythmias that have not returned to normal;
  • Those who have chest pain with known pulmonary embolism or aortic coarctation;
  • Those who are thought to be incapable of completing the MCG examination by an attending physician (or physician with higher qualifications) due to unstable clinical conditions, metal implants, etc;
  • Those who are unable to perform magnetocardiography examinations due to claustrophobia, etc., or those who fail to receive magnetocardiography examination;
  • Those with malignant tumors;
  • Pregnant or lactating women.
  • Those with acute or critical illnesses of other systems, such as acute or severe respiratory illnesses, marked abnormalities in liver function or kidney function.

结局指标

主要结局

Efficacy of MCG for the detection and risk stratification in high-risk patients with chest pain

时间窗: from the date of enrollment until the date of discharge, up to 30 days

Establishing an algorithm model of MCG in identifying high-risk cardiogenic chest pain, the efficacy of the model was assessed by sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and AUC, etc.

Efficacy of MCG for the detection and risk stratification in low-risk patients with chest pain

时间窗: from the date of enrollment until the date of discharge, up to 30 days

Establishing an algorithm model of MCG in identifying low-risk cardiogenic chest pain, the efficacy of the model was assessed by sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and AUC, etc.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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