MyoStrain CMR Testing of Ischemia With Low Levels of Stress
概览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Myocardial Solutions
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Sensitivity of Ischemic CAD Detection
概览
简要总结
This prospective, observational study evaluates the accuracy of stress testing with the MyoStrain SENC CMR Imaging System to detect myocardial ischemia and viability in patients with suspected coronary artery disease using low levels of stress.
详细描述
This prospective, single center study evaluates the MyoStrain SENC CMR Imaging System for the detection of myocardial ischemia and viability during conventional Cardiac Magnetic Resonance (CMR) wall motion stress testing. Patients with known or suspected coronary artery disease and scheduled for cardiac catheterization will be consented for inclusion in the study and evaluated during stress testing with low dose Dobutamine as the stressor agent. Data obtained with the MyoStrain SENC CMR Imaging System will be for observational purposes and will not be used to alter patient management.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Known or suspected Coronary Artery Disease
- •Symptoms potentially due to CAD; stable angina
- •Positive imaging stress test or negative stress test but typical angina or anginal equivalent
- •Negative Troponin with unstable angina
- •Invasive coronary angiography planned within 3 months of CMR
- •Provided written consent
排除标准
- •Pregnancy
- •Contraindication to Magnetic Resonance Imaging
- •Prior allergy to Dobutamine
- •Severe aortic stenosis
- •Hypertrophic Cardiomyopathy
- •Clinically significant Ventricular Tachycardia that would prohibit Dobutamine administration
结局指标
主要结局
Sensitivity of Ischemic CAD Detection
时间窗: Up to coronary angiography within 1 month of standard CMR stress testing
Sensitivity of correctly identifying ischemic coronary artery disease based on cardiac catheterization results using low dose Dobutamine stress testing with MyoStrain software
次要结局
- Specificity of Ischemic CAD Detection(Up to coronary angiography within 1 month of standard CMR stress testing)