NCT06315998招募中不适用
Accurate Identification of Structural Heart Disease Using Magnetocardiography as an Innovative and Non-invasive Tool
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,914
- 试验地点
- 1
- 主要终点
- The efficacy of the MCG in identifying structural heart disease
研究概览
简要总结
The purpose of this prospective cohort study is to determine the parameters of cardiac magnetic imaging to identify structural heart disease using use transthoracic echocardiography or cardiac magnetic resonance as reference standard.
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
- 否
入选标准
- •Those with suspected structural heart disease who are scheduled to undergo echocardiography or cardiac magnetic resonance. Structural heart disease includes cardiomyopathy (hypertrophic cardiomyopathy, dilated cardiomyopathy, restrictive cardiomyopathy, etc.), congenital heart disease (including ventricular septal defect, atrial septal defect, patent ductus arteriosus, Tetralogy of Fallot) syndrome, tricuspid valve malformation, etc.), valvular heart disease (aortic valve stenosis, mitral valve stenosis, etc.), ventricular remodeling caused by myocardial ischemia or cardiac structural changes.
- •Signed the consent form.
排除标准
- •Those with atrial fibrillation, supraventricular tachycardia, atrioventricular block and other arrhythmias that have not returned to normal;
- •Those who are thought to be incapable of completing the relevant examinations by an attending physicians (or physicians with higher qualifications) due to unstable clinical conditions, metal implants, etc., or those who are unable to perform the examinations;
- •Those with obvious abnormal thyroid function, severe anemia or other blood diseases and other diseases that obviously affect the circulating blood supply;
- •Those with malignant tumors;
- •Pregnant or lactating women.
结局指标
主要结局
The efficacy of the MCG in identifying structural heart disease
时间窗: from the date of enrollment until the date of discharge, up to 30 days
Using echocardiography or cardiac magnetic resonance as reference standard to assess the sensitivity, specificity, accuracy, positive predictive value, negative predictive value, and ROC of the cardiac magnetic image algorithm model for identification and localization of structural heart disease.
次要结局
未报告次要终点
研究者
研究点 (1)
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