Comparison of the Use of an Outpatient/Mobile MRI Procedure With an Inpatient MRI Procedure in Adult Patients With Known or Suspected Coronary Artery Disease (CAD)
Comparison of the Use of an Outpatient/Mobile MRI Procedure With an Inpatient MRI Procedure in Adult Patients With Known or Suspected Coronary Heart Disease in a Randomized Open-label Study
Coronary artery disease (CAD) is the clinically relevant manifestation of atherosclerosis affecting the coronary arteries. CAD is associated with an increased risk of morbidity and mortality and typically presents as angina pectoris or dyspnea. Non-invasive imaging techniques are recommended for the diagnosis of CAD. Of particular importance is stress perfusion cardiac magnetic resonance imaging (CMR), which is distinguished from other recommended diagnostic modalities by its high diagnostic accuracy and the absence of exposure of patients and healthcare professionals to ionizing radiation. Consequently, stress perfusion CMR has been assigned a Class I recommendation in international cardiology guidelines.
The aim of this study is to demonstrate the feasibility of transferring the clinical routine workflow for the diagnostic evaluation of patients with suspected coronary artery disease (CAD) from stationary, specialized centers to mobile MRI units.
This will be demonstrated by comparing two groups. In one group, stress CMR examinations will be performed using mobile MRI units, while in the other group, examinations will be conducted in stationary imaging facilities. Participants will be randomly assigned to one of the two groups.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
The diagnostic examinations conducted as part of this study will be performed using stress perfusion cardiac magnetic resonance imaging (CMR) with the pharmacologically active agent regadenoson and the contrast agent gadobutrol. A total of 250 patients with a clinical suspicion of hemodynamically significant coronary artery disease (CAD) will undergo stress perfusion CMR using the pharmacologically active vasodilator regadenoson and the contrast agent gadobutrol. Examinations will be performed in either mobile or stationary MRI units. By introducing stress CMR as a mobile diagnostic service, state-of-the-art, highly accurate diagnostic imaging can also be made available in rural areas. This will enable timely diagnostic examinations close to patients' homes, both for patients with abnormal findings and suspected coronary artery disease and for further diagnostic evaluation of patients with already established CAD. Mobile stress CMR diagnostics will provide the treating specialist with additional information to support clinical decision-making regarding the timely initiation of targeted treatment in the cardiac catheterization laboratory, potentially having a positive impact on subsequent treatment and prognosis.
The study aims to achieve the following objectives:
To demonstrate the feasibility of easily performing stress perfusion CMR in a mobile setting using a short, patient- and user-friendly MRI protocol that is identical to the protocol established in clinical routine practice and recommended by professional societies.
Our hypothesis is that there are no differences in the performance of stress CMR examinations in a mobile setting compared with a stationary setting. The primary endpoints are the proportion of successfully completed and evaluable stress CMR examinations with at least adequate image quality.
Type d'étude
Inscription (Estimé)
Contacts et emplacements
Coordonnées de l'étude
- Nom: Sebastian Kelle, Prof. Dr.
- Numéro de téléphone: +493045931182
- E-mail: sebastian.kelle@dhzc-charite.de
Sauvegarde des contacts de l'étude
- Nom: Gisela Thiede, Dr.
- Numéro de téléphone: +4915209192843
- E-mail: gisela.thiede@dhzc-charite.de
Lieux d'étude
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Berlin, Allemagne, 13353
- Deutsches Herzzentrum der Charité
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Contact:
- Sebastian Kelle, Prof. Dr.
- E-mail: sebastian.kelle@dhzc-charite.de
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
The study population consists of adults with a clinical indication for invasive cardiac diagnostic evaluation due to suspected or known coronary artery disease (CAD).
La description
Inclusion Criteria:
Adults based one of the following criteria:
- Male or female subjects aged ≥18 years
- Clinical indication for invasive cardiac diagnostic evaluation in patients with suspected or known coronary artery disease (CAD)
- Patient fully responsible and can understand/sign the study from a legal aspect
- Patients who have provided written informed consent to participate in the study and to the processing of their personal data
Exclusion Criteria:
- Patient refusal to participate
- Any contraindication to perform an Stress-Perfusion MRI exam
- Contraindication to the cardiac MRI examination (e.g. inability to hold breath; severe claustrophobia, metallic devices such as pace makers)
- Sensorineural hearing loss and tinnitus
- Known pregnancy or lactation
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: OTHER
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
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Mobile Setting Group
Adult patients with suspected coronary artery disease will undergo a clinical indicated stress CMR examination in a mobile MRI unit using stress agent Regadenoson and contrast agent gadobutrol. Stress cardiac examination will be performed In accordance with the protocol established in clinical routine practice and consistent with the MRI examinations performed in the stationary setting group. |
Performing stress cardiac MRI in mobile MRI units vs. stationary MRI units for clinical diagnosis in adult patients with suspected coronary artery disease |
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Stationary Setting Group
Adult patients with suspected coronary artery disease will undergo a clinical indicated stress CMR examination in a stationary MRI unit using stress agent Regadenoson and contrast agent gadobutrol. Stress cardiac examination will be performed In accordance with the protocol established in clinical routine practice. |
Performing stress cardiac MRI in mobile MRI units vs. stationary MRI units for clinical diagnosis in adult patients with suspected coronary artery disease |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Proportion of unsuccessful or non-evaluable stress CMR examinations
Délai: at baseline
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The primary endpoint is the proportion of unsuccessful or non-evaluable stress CMR examinations (e.g., due to adverse events or insufficient image quality) under an identical examination protocol. In the stationary setting, this proportion is approximately 3%. It is assumed that the proportion will also be 3% in the mobile setting, with mobile stress CMR being considered non-inferior provided that the proportion of unsuccessful or non-evaluable stress CMR examinations does not exceed 10%. Based on these assumptions, a non-inferiority test with a one-sided significance level of 2.5% will have 80% power if 94 patients are enrolled in each study arm. |
at baseline
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Sebastian Kelle, Prof. Dr., Deutsches Herzzentrum der Charité
Publications et liens utiles
Publications générales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Estimé)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- Mobile Stress-Perfusion MRI
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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