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.
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: 1. 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). 2. Detect mycocardial perfusion defect indicating significant CAD using Regadenoson 3. Evaluate the image quality of GE-267 in a real-world setting using a quantitative score-systeme
Study Type
OBSERVATIONAL
Enrollment
80
Performing stress-cardiac MRI for clinical diagnostic in adult patients with suspected coronary artery disease
Deutsches Herzzentrum der Charité
Berlin, Germany
Detect mycocardial perfusion defect
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)
Time frame: at baseline
Evaluate the image quality of GE-267
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))
Time frame: at baseline
Recommendation of the patient to further procedure
Recommendation of the patient to further procedure into following classes: I) Unremarkable stress-cMRI -\> Follow Up of the patient by phone call II) Unremarkable stress-cMRI, but pathologic abnormal MRI -\> recommendation for further diagnostic -\> Follow Up of the patient by phone call III) Positive stress-cMRI -\> recommendation for invasive diagnostic -\> Follow Up of the patient by phone call
Time frame: 6-8 months
Comparison of stress-cMRI result and result of invasive diagnostic
Comparison of Group with positive stress-cMRI (and recommendation for invasive diagnostic as well as Follow Up of the patient by phone call 6-8 months after MRI): Stress-cMRI result and result of invasive diagnostic
Time frame: 6-8 months
Total examination time
Total examination time including time patient in, examination, patient out time
Time frame: within 2 hours after baseline
Adverse Effects
Number of Patients with Any (One or More) Regadenoson and/or GE-267-related Adverse-effect
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Time frame: within 2 hours after baseline