CTEPH DIAGNOSIS Europe - MRI

CHANGE-MRI (CTEPH DIAGNOSIS Europe - MRI)

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.

Inclusion Criteria:

• Transthoracic echocardiography indicates pulmonary hypertension
• Patients with clinical suspicion for CTEPH, scheduled for SPECT
• Provided informed consent for the study
• Age >18y

Exclusion Criteria:

• Patient unable to undergo MRI (e.g. due to claustrophobia, cardiac pacemaker, hypersensitivity to MR i.v. contrast imaging agents)
• Women who are pregnant or breast feeding