Frontiers in Cardiovascular Medicine (Apr 2020)
Comparison of MRI and VQ-SPECT as a Screening Test for Patients With Suspected CTEPH: CHANGE-MRI Study Design and Rationale
- Florian Lasch,
- Annika Karch,
- Armin Koch,
- Thorsten Derlin,
- Andreas Voskrebenzev,
- Tawfik Moher Alsady,
- Marius M. Hoeper,
- Marius M. Hoeper,
- Henning Gall,
- Henning Gall,
- Fritz Roller,
- Fritz Roller,
- Sebastian Harth,
- Sebastian Harth,
- Dagmar Steiner,
- Gabriele Krombach,
- Gabriele Krombach,
- Hossein Ardeschir Ghofrani,
- Hossein Ardeschir Ghofrani,
- Fabian Rengier,
- Fabian Rengier,
- Claus Peter Heußel,
- Claus Peter Heußel,
- Claus Peter Heußel,
- Ekkehard Grünig,
- Ekkehard Grünig,
- Dietrich Beitzke,
- Marcus Hacker,
- Irene M. Lang,
- Jürgen Behr,
- Jürgen Behr,
- Peter Bartenstein,
- Julien Dinkel,
- Julien Dinkel,
- Kai-Helge Schmidt,
- Karl-Friedrich Kreitner,
- Thomas Frauenfelder,
- Silvia Ulrich,
- Okka W. Hamer,
- Michael Pfeifer,
- Christopher S. Johns,
- David G. Kiely,
- Andrew James Swift,
- Jim Wild,
- Jens Vogel-Claussen,
- Jens Vogel-Claussen
Affiliations
- Florian Lasch
- Institute of Biostatistics, Hannover Medical School, Hanover, Germany
- Annika Karch
- Institute of Biostatistics, Hannover Medical School, Hanover, Germany
- Armin Koch
- Institute of Biostatistics, Hannover Medical School, Hanover, Germany
- Thorsten Derlin
- Department of Nuclear Medicine, Hannover Medical School, Hanover, Germany
- Andreas Voskrebenzev
- Department of Diagnostic and Interventional Radiology, Hannover Medical School, Hanover, Germany
- Tawfik Moher Alsady
- Department of Diagnostic and Interventional Radiology, Hannover Medical School, Hanover, Germany
- Marius M. Hoeper
- Department of Pneumology, Hannover Medical School, Hanover, Germany
- Marius M. Hoeper
- Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), Member of the German Center for Lung Research (DZL), Hanover, Germany
- Henning Gall
- Department of Pneumology, Medical University Giessen and Marburg, Giessen, Germany
- Henning Gall
- Universities of Giessen and Marburg Lung Center, Marburg, Germany
- Fritz Roller
- Universities of Giessen and Marburg Lung Center, Marburg, Germany
- Fritz Roller
- Department of Radiology, Medical University Giessen and Marburg, Giessen, Germany
- Sebastian Harth
- Universities of Giessen and Marburg Lung Center, Marburg, Germany
- Sebastian Harth
- Department of Radiology, Medical University Giessen and Marburg, Giessen, Germany
- Dagmar Steiner
- Department of Nuclear Medicine, Medical University Giessen and Marburg, Giessen, Germany
- Gabriele Krombach
- Universities of Giessen and Marburg Lung Center, Marburg, Germany
- Gabriele Krombach
- Department of Radiology, Medical University Giessen and Marburg, Giessen, Germany
- Hossein Ardeschir Ghofrani
- Department of Pneumology, Medical University Giessen and Marburg, Giessen, Germany
- Hossein Ardeschir Ghofrani
- Universities of Giessen and Marburg Lung Center, Marburg, Germany
- Fabian Rengier
- 0Diagnostic and Interventional Radiology, University Hospital Heidelberg, Heidelberg, Germany
- Fabian Rengier
- 1Translational Lung Research Center (TLRC) Heidelberg, Member of the German Center for Lung Research (DZL), University of Heidelberg, Heidelberg, Germany
- Claus Peter Heußel
- 0Diagnostic and Interventional Radiology, University Hospital Heidelberg, Heidelberg, Germany
- Claus Peter Heußel
- 1Translational Lung Research Center (TLRC) Heidelberg, Member of the German Center for Lung Research (DZL), University of Heidelberg, Heidelberg, Germany
- Claus Peter Heußel
- 2Department of Diagnostic and Interventional Radiology With Nuclear Medicine, Thoraxklinik at University Hospital Heidelberg, Heidelberg, Germany
- Ekkehard Grünig
- 1Translational Lung Research Center (TLRC) Heidelberg, Member of the German Center for Lung Research (DZL), University of Heidelberg, Heidelberg, Germany
- Ekkehard Grünig
- 3Centre for Pulmonary Hypertension, Thoraxklinik at Heidelberg University Hospital, Heidelberg, Germany
- Dietrich Beitzke
- 4Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria
- Marcus Hacker
- 4Department of Biomedical Imaging and Image-Guided Therapy, Medical University of Vienna, Vienna, Austria
- Irene M. Lang
- 5Department of Cardiology, Internal Medicine II, Medical University of Vienna, Vienna, Austria
- Jürgen Behr
- 6Department of Pneumology, Ludwig-Maximilan University Munich, Munich, Germany
- Jürgen Behr
- 7Comprehensive Pneumology Center, Munich, Ludwig-Maximilians-University Munich and Asklepios Hospital Munich-Gauting and Helmholtz Center Munich, Member of the German Center for Lung Research (DZL), Munich, Germany
- Peter Bartenstein
- 8Department of Nuclear Medicine, Ludwig-Maximilan University, Munich, Germany
- Julien Dinkel
- 7Comprehensive Pneumology Center, Munich, Ludwig-Maximilians-University Munich and Asklepios Hospital Munich-Gauting and Helmholtz Center Munich, Member of the German Center for Lung Research (DZL), Munich, Germany
- Julien Dinkel
- 9Department of Radiology, Ludwig-Maximilan University Munich, Munich, Germany
- Kai-Helge Schmidt
- 0Department of Cardiology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany
- Karl-Friedrich Kreitner
- 1Department of Diagnostic and Interventional Radiology, University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Germany
- Thomas Frauenfelder
- 2Department of Diagnostic and Interventional Radiology, University Hospital Zurich, Zurich, Switzerland
- Silvia Ulrich
- 3Department of Respiratory Medicine, Pulmonary Hypertension Unit, University Hospital Zurich, Zurich, Switzerland
- Okka W. Hamer
- 4Department of Radiology, Regensburg University Hospital, Regensburg, Germany
- Michael Pfeifer
- 5Department of Pneumology, Regensburg University Hospital, Regensburg, Germany
- Christopher S. Johns
- 6Academic Unit of Radiology, University of Sheffield, Sheffield, United Kingdom
- David G. Kiely
- 7Sheffield Pulmonary Vascular Disease Unit, Royal Hallamhire Hospital, Sheffield, United Kingdom
- Andrew James Swift
- 8Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom
- Jim Wild
- 8Department of Infection, Immunity and Cardiovascular Disease, University of Sheffield, Sheffield, United Kingdom
- Jens Vogel-Claussen
- Department of Diagnostic and Interventional Radiology, Hannover Medical School, Hanover, Germany
- Jens Vogel-Claussen
- Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), Member of the German Center for Lung Research (DZL), Hanover, Germany
- DOI
- https://doi.org/10.3389/fcvm.2020.00051
- Journal volume & issue
-
Vol. 7
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, ClinicalTrials.gov 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.
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