Coronary Artery Disease
Conditions
Keywords
Cardiac MRI, Stress perfusion cardiac MRI, Regadenoson, GE-267, Diagnosis, Rural Region, mycocardial perfusion defect, mobile MRI, CMR, Cardiac Magnetic Resonance
Brief summary
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.
Detailed description
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
Interventions
DIAGNOSTIC_TESTCardiac MRI using Regadenoson and GE-267
Performing stress-cardiac MRI for clinical diagnostic in adult patients with suspected coronary artery disease
Sponsors
GE Healthcare
German Heart Institute
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Adults with known or suspected coronary artery disease based one of the following criteria: 1. Abnormal CMR without stress in a previous CMR measurement (e.g. new onset of wall motion abnormalities or reduced LVEF) 2. Referral from local cardiologist based on one of the following criteria: 1. Patients has a diagnosed coronary artery disease based on other methods 2. 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. 3. Patients demonstrate chronic kidney disease (CKD III or higher) and diabetes 4. 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Detect mycocardial perfusion defect | 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 | 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)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recommendation of the patient to further procedure | 6-8 months | 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 |
| Comparison of stress-cMRI result and result of invasive diagnostic | 6-8 months | 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 |
| Total examination time | within 2 hours after baseline | Total examination time including time patient in, examination, patient out time |
| Adverse Effects | within 2 hours after baseline | Number of Patients with Any (One or More) Regadenoson and/or GE-267-related Adverse-effect |
Countries
Germany
Contacts
Primary ContactSebastian Kelle, Prof. Dr.
Backup ContactGisela Thiede, Dr.
Outcome results
None listed