AzTrials
AzTrials

Coronary Artery DiseaseNCT06246188

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

An observational study of Coronary Artery Disease, run by German Heart Institute at 1 site in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease
What is being tested?
Cardiac MRI using Regadenoson and GE-267
How many people
80 participants
Where
1 siteGermany
Study dates
1 Jun 2025to 31 Dec 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • Adults with known or suspected coronary artery disease based one of the following criteria:
  • Abnormal CMR without stress in a previous CMR measurement (e.g. new onset of wall motion abnormalities or reduced LVEF)
  • Referral from local cardiologist based on one of the following criteria:
  • Patients has a diagnosed coronary artery disease based on other methods
  • 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.
  • Patients demonstrate chronic kidney disease (CKD III or higher) and diabetes
Show all 9Show fewer
  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Sebastian Kelle, Prof. Dr. contact

+493045931182

sebastian.kelle@dhzc-charite.de

Gisela Thiede, Dr. contact

+4915209192843

gisela.thiede@dhzc-charite.de

Germany1 site

  • Deutsches Herzzentrum der Charité

    Berlin, 13353

    Sebastian Kelle, Prof. Dr., sebastian.kelle@dhzc-charite.de

Other trials in Germany

About this study

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

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.

Read the 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
Being tested
Cardiac MRI using Regadenoson and GE-267
Keywords
Cardiac MRI, Stress perfusion cardiac MRI, Regadenoson, GE-267, Diagnosis, Rural Region, mycocardial perfusion defect, mobile MRI, CMR, Cardiac Magnetic Resonance
Medical subject headings
Coronary Artery Disease, Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cardiac MRI using Regadenoson and GE-267Diagnostic test

    Performing stress-cardiac MRI for clinical diagnostic in adult patients with suspected coronary artery disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Detect mycocardial perfusion defect

    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)

    Measured: at baseline

  2. Evaluate the image quality of GE-267

    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))

    Measured: at baseline

Secondary outcomes (4)

  1. Recommendation of the patient to further procedure

    Recommendation of the patient to further procedure into following classes:

    1. 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

    Measured: 6-8 months

  2. Comparison of stress-cMRI result and result of invasive diagnostic

    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

    Measured: 6-8 months

  3. Total examination time

    Total examination time including time patient in, examination, patient out time

    Measured: within 2 hours after baseline

  4. Adverse Effects

    Number of Patients with Any (One or More) Regadenoson and/or GE-267-related Adverse-effect

    Measured: within 2 hours after baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Feb 2024
  2. Study start1 Jun 2025 (estimated)
  3. Primary completion31 Dec 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
80 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06246188
Sponsor's protocol ID
RAPS-22-02
Status last verified
Apr 2024
First submitted
30 Jan 2024
Last updated
25 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Nagel E, Klein C, Paetsch I, Hettwer S, Schnackenburg B, Wegscheider K, Fleck E. Magnetic resonance perfusion measurements for the noninvasive detection of coronary artery disease. Circulation. 2003 Jul 29;108(4):432-7. doi: 10.1161/01.CIR.0000080915.35024.A9. Epub 2003 Jul 14.

    PubMed 12860910

  • Hundley WG, Hamilton CA, Thomas MS, Herrington DM, Salido TB, Kitzman DW, Little WC, Link KM. Utility of fast cine magnetic resonance imaging and display for the detection of myocardial ischemia in patients not well suited for second harmonic stress echocardiography. Circulation. 1999 Oct 19;100(16):1697-702. doi: 10.1161/01.cir.100.16.1697.

    PubMed 10525488

  • Kelle S, Roes SD, Klein C, Kokocinski T, de Roos A, Fleck E, Bax JJ, Nagel E. Prognostic value of myocardial infarct size and contractile reserve using magnetic resonance imaging. J Am Coll Cardiol. 2009 Nov 3;54(19):1770-7. doi: 10.1016/j.jacc.2009.07.027.

    PubMed 19874990

  • Tschope C, Ammirati E, Bozkurt B, Caforio ALP, Cooper LT, Felix SB, Hare JM, Heidecker B, Heymans S, Hubner N, Kelle S, Klingel K, Maatz H, Parwani AS, Spillmann F, Starling RC, Tsutsui H, Seferovic P, Van Linthout S. Myocarditis and inflammatory cardiomyopathy: current evidence and future directions. Nat Rev Cardiol. 2021 Mar;18(3):169-193. doi: 10.1038/s41569-020-00435-x. Epub 2020 Oct 12.

    PubMed 33046850

  • Weiss KJ, Nasser SB, Bigvava T, Doltra A, Schnackenburg B, Berger A, Anker MS, Stehning C, Doeblin P, Abdelmeguid M, Talat M, Gebker R, E-Naggar W, Pieske B, Kelle S. Long-term prognostic value of vasodilator stress cardiac magnetic resonance in patients with atrial fibrillation. ESC Heart Fail. 2022 Feb;9(1):110-121. doi: 10.1002/ehf2.13736. Epub 2021 Dec 6.

    PubMed 34866358

  • Sengupta PP, Kramer CM, Narula J, Dilsizian V. The Potential of Clinical Phenotyping of Heart Failure With Imaging Biomarkers for Guiding Therapies: A Focused Update. JACC Cardiovasc Imaging. 2017 Sep;10(9):1056-1071. doi: 10.1016/j.jcmg.2017.07.001.

    PubMed 28882290

  • Zeppenfeld K, Tfelt-Hansen J, de Riva M, Winkel BG, Behr ER, Blom NA, Charron P, Corrado D, Dagres N, de Chillou C, Eckardt L, Friede T, Haugaa KH, Hocini M, Lambiase PD, Marijon E, Merino JL, Peichl P, Priori SG, Reichlin T, Schulz-Menger J, Sticherling C, Tzeis S, Verstrael A, Volterrani M; ESC Scientific Document Group. 2022 ESC Guidelines for the management of patients with ventricular arrhythmias and the prevention of sudden cardiac death. Eur Heart J. 2022 Oct 21;43(40):3997-4126. doi: 10.1093/eurheartj/ehac262. No abstract available.

    PubMed 36017572

  • Kramer CM, Barkhausen J, Bucciarelli-Ducci C, Flamm SD, Kim RJ, Nagel E. Standardized cardiovascular magnetic resonance imaging (CMR) protocols: 2020 update. J Cardiovasc Magn Reson. 2020 Feb 24;22(1):17. doi: 10.1186/s12968-020-00607-1.

    PubMed 32089132

  • Pavon AG, Porretta AP, Arangalage D, Domenichini G, Rutz T, Hugelshofer S, Pruvot E, Monney P, Pascale P, Schwitter J. Feasibility of adenosine stress cardiovascular magnetic resonance perfusion imaging in patients with MR-conditional transvenous permanent pacemakers and defibrillators. J Cardiovasc Magn Reson. 2022 Jan 13;24(1):9. doi: 10.1186/s12968-021-00842-0.

    PubMed 35022037

  • Doltra A, Skorin A, Hamdan A, Schnackenburg B, Gebker R, Klein C, Nagel E, Fleck E, Kelle S. Comparison of acquisition time and dose for late gadolinium enhancement imaging at 3.0 T in patients with chronic myocardial infarction using Gd-BOPTA. Eur Radiol. 2014 Sep;24(9):2192-200. doi: 10.1007/s00330-014-3213-y. Epub 2014 May 15.

    PubMed 24828537

Questions about this trial

What is this clinical trial studying?

An observational study of Coronary Artery Disease, run by German Heart Institute at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sebastian Kelle, Prof. Dr. (+493045931182, sebastian.kelle@dhzc-charite.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Detect mycocardial perfusion defect (time frame: at baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06246188, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in