Magnetocardiography as an Innovative Diagnostic Tool for Early and Accurate Identification of Myocardial Ischemia in Suspected NSTE-ACS Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 14,090
- 试验地点
- 1
- 主要终点
- Efficacy of MCG to detect coronary ischemia in patients with suspected NSTE-ACS
研究概览
简要总结
The goal of this multi-center observational study is to learn about the effectiveness of magnetocardiography in rapid and accurate identification of ischemia in patients with suspected NSTE-ACS.
详细描述
Rapid and accurate Identification of ischemia in patients with chest pain suspected of non-ST-elevation-acute coronary syndrome (NSTE-ACS) is of great clinical significance for timely and effective treatment. Magnetocardiography based on spin-exchange relaxation-free (SERF) principle can detect the weak magnetic field generated by the heart sensitively, which do not need ultra-low temperature cooling. Magnetic signal does not decay through the skin and tissues as electricity does, hence magnetocardiogram (MCG) contains more information of diagnostic value of ischemia. The aim of this observational study is to optimize and validate MCG models as a fast and accurate strategy for detecting coronary ischemia, as a shortage of blood supply to myocardium, in patients who suffer from chest pain, and compare to routine diagnostic means.
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
- 否
入选标准
- •Age 18 years or older;
- •Patients with symptoms of myocardial ischemia such as angina who are suspected to NSTE-ACS and proposed to undergo CAG or coronary CTA;
- •Signed informed consent.
排除标准
- •Patients with ST-elevation myocardial infarction (STEMI);
- •Patients with Non-ischemic dilated cardiomyopathy, or hypertrophic cardiomyopathy, or moderate or severe valvular disease;
- •Patients with Hemodynamic instability (systolic blood pressure<90 mmHg, or who requires vasoactive drugs), or patients with tachyarrhythmia, Ⅱ degree atrioventricular block and above that have not returned to normal;
- •Patients who have severe renal abnormality with eGFR <30 ml/min, or patients who are on dialysis;
- •Patients with malignant tumors with predicted survival of less than 1 year;
- •Pregnant or breastfeeding women;
- •Patients who are unable to enter the MCG device, who are unable to perform MCG examination due to interference from metal implants or other reasons, or who are deemed by the investigators to be unsuitable for enrollment.
结局指标
主要结局
Efficacy of MCG to detect coronary ischemia in patients with suspected NSTE-ACS
时间窗: from the date of enrollment until the date of discharge, up to 30 days
the sensitivity and specificity of MCG to detect coronary ischemia (defined as stenosis ≥ 90% or fractional flow reserve ≤0.8）
次要结局
- The time saved by using MCG in the detection of NSTEMI compared to troponin(from the date of enrollment until the date of discharge, up to 30 days)
- Efficacy of MCG in identifying coronary ischemia in patients with normal ECG.(from the date of enrollment until the date of discharge, up to 30 days)
- Efficacy of MCG in evaluating the severity of coronary lesions.(from the date of enrollment until the date of discharge, up to 30 days)
- Efficacy of MCG in early stratification of patients with suspected NSTE-ACS(from the date of enrollment until the date of discharge, up to 30 days)