NCT06255769招募中不适用
Identification of Myocardial Ischemia With Magnetocardiography Using Single Photon Emission Computed Tomography (SPECT) as a Reference Standard
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 1
- 主要终点
- Efficacy of MCG to detect myocardial ischemia using SPECT as a reference standard.
研究概览
简要总结
This is a prospective clinical study aiming to investigate the efficacy of Magnetocardiography (MCG) in detecting myocardial ischemia in patients of a suspected non-ST-elevation-acute coronary syndrome (NSTE-ACS) by using Single photon emission computed tomography (SPECT) as the gold standard for determining the presence and severity of myocardial ischemia.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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 pectoris, who have CAG showing <70% stenosis at the most severe site or CTA showing non-severe stenosis
- •Signed informed consent.
排除标准
- •Patients with absolute or relative contraindications to SPECT-loaded myocardial perfusion, including acute myocardial infarction within 48 hours, significant left main coronary artery stenosis, bronchial asthma, and adenosine injection allergy;
- •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, Ⅱdegree 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 myocardial ischemia using SPECT as a reference standard.
时间窗: from the date of enrollment until the date of discharge, up to 30 days
Sensitivity, specificity, and area under the ROC curve are performed for assessing the efficacy.
次要结局
- Efficacy of MCG to detect myocardial ischemia in patients with coronary stenosis <50% (Ischemia with no obstructive coronary artery, INOCA)(from the date of enrollment until the date of discharge, up to 30 days)
研究者
研究点 (1)
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