Use of Stress-CMR Using Regadenoson and GE-267 in Adult Patients with Known or Suspected Coronary Artery Disease Using Mobile Cardiac MRI Units in a Single-arm Open-label Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Detect mycocardial perfusion defect
研究概览
简要总结
Stress cardiac MRI is crucial for diagnosing coronary artery disease in adults. Currently, it is mainly performed with vasodilators in specialized centers. Introducing mobile CMR units could increase accessibility, especially in rural areas, potentially reducing unnecessary invasive procedures. The objectives include demonstrating the feasibility of mobile stress perfusion CMR, detecting CAD using Regadenoson, and evaluating the image quality of GE-267 in real-world scenarios.
详细描述
Stress-cardiac MRI (CMR) has a Class I indication for the clinical diagnostic workup in adult patients with suspected coronary artery disease (CAD), including those with epicardial as well as microvascular disease (Gulati M et al. 2021; Zeppenfeld et al. 2022). According to large registry data, in more than 90% of stress-CMR-exams the test was performed using a vasodilator (Adenosine/Regadenoson) at tertiary care centers. However, the use of mobile CMR-units would make this high-end diagnostic tool available to much more patients, especially in rural areas, and by this potentially decrease the rate of unnecessary invasive procedures to rule out CAD. Therefore, we define following objectives:
- Demonstrate the easy performance of stress Perfusion CMR in a mobile setting using a short and patient/user friendly CMR-protocol. Our hypothesis is that there are no differences in performing stress CMR using a mobile setting versus a stationary setting (based on published literature).
- Detect mycocardial perfusion defect indicating significant CAD using Regadenoson
- Evaluate the image quality of GE-267 in a real-world setting using a quantitative score-systeme
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
- •Adults with known or suspected coronary artery disease based one of the following criteria:
- •Abnormal CMR without stress in a previous CMR measurement (e.g. new onset of wall motion abnormalities or reduced LVEF)
- •Referral from local cardiologist based on one of the following criteria:
- •Patients has a diagnosed coronary artery disease based on other methods
- •Patients has a high-risk profile based on risk stratification using clinical evaluation (ESC-Score > 5%), the assessment of LV function by resting echocardiography, and, in the majority of cases, non-invasive assessment of ischaemia or coronary anatomy.
- •Patients demonstrate chronic kidney disease (CKD III or higher) and diabetes
- •Patients demonstrate history of peripheral artery disease (PTA/Stent) or TEA of the carotids or previous operation of atherosclerotic aortic aneurysms
- •Male or female subjects aged ≥18 years
- •Patient fully responsible and can understand/sign the study from a legal aspect
排除标准
- •Patient refusal to participate
- •Any contraindication to perform an MRI exam
- •Known Hypersensitivity to the active substance or to any of the excipients in Regadenoson or GE-267
- •Any contraindication to aminophylline or theophylline: hypotension, unstable cardiac arrhythmias and acute coronary symptoms
- •Unstable angina that has not been stabilized with medical therapy
- •Severe hypotension
- •Decompensated states of heart failure
- •Severe Arrhythmias
- •Contraindication to the cardiac MRI examination (e.g. inability to hold breath; severe claustrophobia, metallic devices such as pace makers)
- •Second or third degree atrioventricular (AV) block or sinus node dysfunction, unless these patients have a functioning artificial pacemaker
- •Known pregnancy or lactation
结局指标
主要结局
Detect mycocardial perfusion defect
时间窗: at baseline
Presence of a myocardial perfusion defect indicating significant CAD per participant on GE-267-enhanced cMRI using Regadenoson (detected by visual assessment and/or quantitative perfusion)
Evaluate the image quality of GE-267
时间窗: at baseline
Signal intensity of GE-267 meglumine during perfusion cardiovascular magnetic resonance (detected by quantitative assessment by a score system by two experienced readers and/or image quality assessment by Philips software (SNR/CNR))
次要结局
- Recommendation of the patient to further procedure(6-8 months)
- Comparison of stress-cMRI result and result of invasive diagnostic(6-8 months)
- Total examination time(within 2 hours after baseline)
- Adverse Effects(within 2 hours after baseline)
研究者
Sebastian Kelle
Univ.-Prof. Dr. med.
German Heart Institute