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

January 30, 2024 updated by: Sebastian Kelle, German Heart Institute

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

The population from which the groups or cohorts will be selected are adults with known or suspected coronary artery disease located in Brandenburg or Mecklenburg-Western Pomerania. Either they already participated in the HerzCheck-Trial (NCT05122793) or they are referred from local cardiologists.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detect mycocardial perfusion defect
Time Frame: 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)
at baseline
Evaluate the image quality of GE-267
Time Frame: 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))
at baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recommendation of the patient to further procedure
Time Frame: 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
6-8 months
Comparison of stress-cMRI result and result of invasive diagnostic
Time Frame: 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
6-8 months
Total examination time
Time Frame: within 2 hours after baseline
Total examination time including time patient in, examination, patient out time
within 2 hours after baseline
Adverse Effects
Time Frame: within 2 hours after baseline
Number of Patients with Any (One or More) Regadenoson and/or GE-267-related Adverse-effect
within 2 hours after baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German Heart Institute

Collaborators

GE Healthcare

Investigators

  • Principal Investigator: Sebastian Kelle, Prof. Dr., German Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

July 31, 2025

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

February 7, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RAPS-22-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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