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| Name | Class |
|---|---|
| University of Sheffield | OTHER |
| University of Giessen | OTHER |
| Ludwig-Maximilians - University of Munich | OTHER |
| Heidelberg University |
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Phase III diagnostic trial to demonstrate that functional lung MRI can replace VQ-SPECT in a diagnostic strategy for patients with suspected CTEPH where positive findings are verified with catheter pulmonary angiography (CPA), or computed tomography pulmonary angiography (CTPA)
CHANGE-MRI is a prospective, multicentre, comparative phase III diagnostic study. The study aims to show via an in-place validation that MRI can replace VQ-SPECT as a screening test for chronic pulmonary embolism in the diagnostic algorithm for CTEPH. The diagnostic gold standard is catheter pulmonary angiography (CPA) or computed tomography pulmonary angiography (CTPA) with correction from the clinical outcome after 6-12 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Index test: functional dynamic contrast enhanced (DCE)-MRI | Other | Patients with clinical suspicion for CTEPH, scheduled for SPECT |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Index test: functional dynamic contrast enhanced (DCE)-MRI | Other | Index test: functional dynamic contrast enhanced (DCE)-MRI Reference test: Ventilation-perfusion (VQ) single-photon emission computed tomography (SPECT) Follow-up per patient: clinical assessment after 6-12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of patients with positive MRI in the group of patients who have a positive VQ-SPECT diagnosis for chronic pulmonary embolism and who are positive in the gold standard | 6 months | |
| The proportion of patients with positive MRI in the group of patients with negative VQ-SPECT who are negative in the gold standard | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jens Vogel-Claussen, MD | Contact | +49 511 5323421 | vogel-claussen.jens@mh-hannover.de |
| Name | Affiliation | Role |
|---|---|---|
| Jens Vogel-Claussen, MD | Hannover Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hannover Medical School | Recruiting | Hanover | Lower Saxony | 30625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32328500 | Derived | Lasch F, Karch A, Koch A, Derlin T, Voskrebenzev A, Alsady TM, Hoeper MM, Gall H, Roller F, Harth S, Steiner D, Krombach G, Ghofrani HA, Rengier F, Heussel CP, Grunig E, Beitzke D, Hacker M, Lang IM, Behr J, Bartenstein P, Dinkel J, Schmidt KH, Kreitner KF, Frauenfelder T, Ulrich S, Hamer OW, Pfeifer M, Johns CS, Kiely DG, Swift AJ, Wild J, Vogel-Claussen J. Comparison of MRI and VQ-SPECT as a Screening Test for Patients With Suspected CTEPH: CHANGE-MRI Study Design and Rationale. Front Cardiovasc Med. 2020 Apr 9;7:51. doi: 10.3389/fcvm.2020.00051. eCollection 2020. |
| Label | URL |
|---|---|
| study website | View source |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| OTHER |
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| D002318 |
| Cardiovascular Diseases |