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.
Highlights
The Clinical ProblemChronic thromboembolic pulmonary hypertension (CTEPH) occurs in 0.1–4.0% of patients with acute pulmonary embolism (PE) within 2 years [1]
CHANGE-magnetic resonance imaging (MRI) is a prospective, multicenter, comparative phase III diagnostic study undertaken by the German Centre for Lung Research (DZL): Centre for Biomedical Research in Endstage and Obstructive Lung Disease Hannover (BREATH), the Universities of Giessen and Marburg Lung Centre (LGMLC), the Comprehensive Pneumology Centre Munich, the Translational Lung Research Centre Heidelberg (TLRC-H), the University of Sheffield, the Medical University of Vienna, the University Medical Centre of the Johannes Gutenberg University Mainz, the University Hospital Zurich and the University Hospital Regensburg
The diagnostic strategy for Clinical ProblemChronic thromboembolic pulmonary hypertension (CTEPH) is basically composed of two components leading to a final diagnosis for or against CTEPH: 1) Presence of chronic pulmonary embolism, and 2) Presence of elevated pulmonary artery pressure
Summary
Chronic thromboembolic pulmonary hypertension (CTEPH) occurs in 0.1–4.0% of patients with acute pulmonary embolism (PE) within 2 years [1]. Novel 4D dynamic contrast-enhanced (DCE) lung perfusion magnetic resonance imaging (MRI) techniques [11] are widely available on current MRI systems and have shown excellent test performance in diagnosing CTEPH in a single center registry setting in Sheffield [ASPIRE registry [12]]. In the CHANGE-MRI study we implemented phase-resolved functional lung (PREFUL) MRI as a secondary outcome parameter, which is a further development of Fourier Decomposition MRI depicting the whole breathing and cardiac cycle [15] These novel functional MRI techniques hold significant potential to be an equal rights non-ionizing alternative to VQ-SPECT in the near future, if they can demonstrate robust test performance in a prospective multicenter setting (Figure 2).
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