Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06246188
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-01-30
Brief Title:
Use of Stress-CMR Using Regadenoson and GE-267 in Adult Patients With Known or Suspected Coronary Artery Disease
Sponsor:
German Heart Institute
Organization:
German Heart Institute
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 AdenosineRegadenoson 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 patientuser 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
1 Demonstrate the easy performance of stress Perfusion CMR in a mobile setting using a short and patientuser 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None