Use of Stress-CMR Using Regadenoson and GE-267 in Adult Patients with Known or Suspected Coronary Artery Disease

Not yet recruiting

• Conditions: Coronary Artery Disease

• Registration Number: NCT06246188
• Lead Sponsor: German Heart Institute

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

Study Timeline

• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-02-07
• Status Verified: 2024-04
• Last Update Submitted: 2025-03-20
• Last Update Posted: 2025-03-25
• Study Start: 2025-06-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Deutsches Herzzentrum der Charité; 🇩🇪 Berlin, Germany