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| Name | Class |
|---|---|
| GE Healthcare | INDUSTRY |
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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.
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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiac MRI using Regadenoson and GE-267 | Diagnostic Test | Performing stress-cardiac MRI for clinical diagnostic in adult patients with suspected coronary artery disease |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | at baseline |
| 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)) | at baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Recommendation of the patient to further procedure | 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 |
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Inclusion Criteria:
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
Patients demonstrate history of peripheral artery disease (PTA/Stent) or TEA of the carotids or previous operation of atherosclerotic aortic aneurysms
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sebastian Kelle, Prof. Dr. | Contact | +493045931182 | sebastian.kelle@dhzc-charite.de | |
| Gisela Thiede, Dr. | Contact | +4915209192843 | gisela.thiede@dhzc-charite.de |
| Name | Affiliation | Role |
|---|---|---|
| Sebastian Kelle, Prof. Dr. | Deutsches Herzzentrum der Charité | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deutsches Herzzentrum der Charité | Berlin | 13353 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12860910 | Background | 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. | |
| 10525488 | Background | 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. |
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| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D004194 | Disease |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 6-8 months |
| 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 | 6-8 months |
| Total examination time | Total examination time including time patient in, examination, patient out time | within 2 hours after baseline |
| Adverse Effects | Number of Patients with Any (One or More) Regadenoson and/or GE-267-related Adverse-effect | within 2 hours after baseline |
| 19874990 | Background | 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. |
| 33046850 | Background | 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. |
| 34866358 | Background | 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. |
| 28882290 | Background | 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. |
| 36017572 | Background | 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. |
| 32089132 | Background | 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. |
| 35022037 | Background | 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. |
| 24828537 | Background | 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. |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |