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

Coronary Artery Disease Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06246188
Study type Observational
Source German Heart Institute
Contact Sebastian Kelle, Prof. Dr.
Phone +493045931182
Email sebastian.kelle@dhzc-charite.de
Status Not yet recruiting
Phase
Start date May 1, 2024
Completion date July 31, 2025
View Details
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