Research on Diagnosis and Prognosis of Myocardial Ischemia Level in Xiangya Hospital Using Magnetocardiography -- Miracle MCG
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 146
- 主要终点
- Consistency of diagnosis of myocardial infarction level
研究概览
简要总结
Magnetocardiography (MCG) is a non-invasive and accurate method of detecting myocardial ischemia. However, the previous MCG is limited in clinical practice due to its high working conditions and limited sensitivity. The next-generation MCG based on optical pumped magnetometer (OPM) has the advantages of high sensitivity, high reliability, high usability and low cost, which makes it suitable for most medical scenarios. Thus, this prospective single-center study aimed to use OPM MCG to explore its diagnostic efficacy and predictive value for myocardial ischemia. Participants who will receive coronary angiography examinations will be enrolled in this study. Participants enrolled in the study will also have a 1, 3, 6, 12, 24, 36, and 48-month follow-up for analysis of adverse cardiac events.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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 old;
- •Those who are suspected of coronary heart disease and scheduled to undergo coronary angiography;
- •Sign the informed consent.
排除标准
- •Complex arrhythmia, including frequent premature atrial beats, premature ventricular beats, atrial fibrillation, atrial flutter, and complete bundle branch block;
- •Severe hypertension (> 180/110 mmHg);
- •Congenital heart diseases, valvular heart diseases, or implantation of pacemakers or drug pumps.
- •Severe thoracic or pulmonary diseases, thoracic malformation, or history of thoracic surgery;
- •Pregnant or breastfeeding women;
- •Claustrophobia, or those who can't lie still for 2 minutes in a confined space;
- •Allergy to contrast agent;
- •Renal impairment: serum creatinine > 2,0 mg/dl (176.8 μmol/L) or those who are receiving hemodialysis;
- •Other diseases, including malignant tumors, organ transplantation, and candidates for organ transplantation;
- •History of alcohol or drug abuse (cocaine, heroin, etc.);
- •Participating in clinical studies of other drugs or devices without reaching the time limit for the primary endpoint;
- •Those who aren't suitable for inclusion due to other reason.
结局指标
主要结局
Consistency of diagnosis of myocardial infarction level
时间窗: up to 6 months
The myocardial ischemic level is measured by MCG and coronary angiography examination. The result of the coronary angiography examination is independently judged by three experienced clinicians. Calculate the consistency to evaluate the diagnosis of myocardial infarction level reliability.
Kappa statistics of diagnosis of myocardial infarction level
时间窗: up to 6 months
The myocardial ischemic level is measured by MCG and coronary angiography examination. The result of the coronary angiography examination is independently judged by three experienced clinicians. Calculate the Kappa statistics to evaluate the diagnosis of myocardial infarction level reliability.
Specificity of diagnosis of myocardial infarction level
时间窗: up to 6 months
The myocardial ischemic level is measured by MCG and coronary angiography examination. The result of the coronary angiography examination is independently judged by three experienced clinicians. And calculate the specificity to evaluate the diagnosis of myocardial infarction level validity.
Sensitivity of diagnosis of myocardial infarction level
时间窗: up to 6 months
The myocardial ischemic level is measured by MCG and coronary angiography examination. The result of the coronary angiography examination is independently judged by three experienced clinicians. And calculate the sensitivity to evaluate the diagnosis of myocardial infarction level validity.
次要结局
- Incidence of major adverse cardiovascular events(through study completion, an avarage of 2 years)