Comparison of MRI and VQ-SPECT as a Screening Test for Patients With Suspected CTEPH: CHANGE-MRI Study Design and Rationale

Lasch, Florian and Karch, Annika and Koch, Armin and Derlin, Thorsten and Voskrebenzev, Andreas and Alsady, Tawfik Moher and Hoeper, Marius M. and Gall, Henning and Roller, Fritz and Harth, Sebastian and Steiner, Dagmar and Krombach, Gabriele and Ghofrani, Hossein Ardeschir and Rengier, Fabian and Heussel, Claus Peter and Gruenig, Ekkehard and Beitzke, Dietrich and Hacker, Marcus and Lang, Irene M. and Behr, Juergen and Bartenstein, Peter and Dinkel, Julien and Schmidt, Kai-Helge and Kreitner, Karl-Friedrich and Frauenfelder, Thomas and Ulrich, Silvia and Hamer, Okka W. and Pfeifer, Michael and Johns, Christopher S. and Kiely, David G. and Swift, Andrew James and Wild, Jim and Vogel-Claussen, c (2020) Comparison of MRI and VQ-SPECT as a Screening Test for Patients With Suspected CTEPH: CHANGE-MRI Study Design and Rationale. FRONTIERS IN CARDIOVASCULAR MEDICINE, 7: 51. ISSN 2297-055X,

Full text not available from this repository. (Request a copy)

Abstract

The diagnostic strategy for chronic thromboembolic pulmonary hypertension (CTEPH) is composed of two components required for a diagnosis of CTEPH: the presence of chronic pulmonary embolism and an elevated pulmonary artery pressure. The current guidelines require that ventilation-perfusion single-photon emission computed tomography (VQ-SPECT) is used for the first step diagnosis of chronic pulmonary embolism. However, VQ-SPECT exposes patients to ionizing radiation in a radiation sensitive population. The prospective, multicenter, comparative phase III diagnostic trial CTEPH diagnosis Europe - MRI (CHANGE-MRI, identifier NCT02791282) aims to demonstrate whether functional lung MRI can serve as an equal rights alternative to VQ-SPECT in a diagnostic strategy for patients with suspected CTEPH. Positive findings are verified with catheter pulmonary angiography or computed tomography pulmonary angiography (gold standard). For comparing the imaging methods, a co-primary endpoint is used. (i) the proportion of patients with positive MRI in the group of patients who have a positive SPECT and gold standard diagnosis for chronic pulmonary embolism and (ii) the proportion of patients with positive MRI in the group of patients with negative SPECT and gold standard. The CHANGE-MRI trial will also investigate the performance of functional lung MRI without i.v. contrast agent as an index test and identify cardiac, hemodynamic, and pulmonary MRI-derived parameters to estimate pulmonary artery pressures and predict 6-12 month survival. Ultimately, this study will provide the necessary evidence for the discussion about changes in the recommendations on the diagnostic approach to CTEPH.

Item Type: Article
Uncontrolled Keywords: MAGNETIC-RESONANCE ANGIOGRAPHY; PULMONARY-EMBOLISM; VENTILATION; DIAGNOSIS; BIAS; MRI; VQ-SPECT; CTEPH; PH; pulmonary embolism; diagnostic strategy
Subjects: 600 Technology > 610 Medical sciences Medicine
Divisions: Medicine > Lehrstuhl für Innere Medizin II
Medicine > Lehrstuhl für Röntgendiagnostik
Depositing User: Dr. Gernot Deinzer
Date Deposited: 26 Mar 2021 12:43
Last Modified: 26 Mar 2021 12:43
URI: https://pred.uni-regensburg.de/id/eprint/44752

Actions (login required)

View Item View Item