CTEPH DIAGNOSIS Europe - MRI
- Conditions
- Pulmonary Hypertension
- Registration Number
- NCT02791282
- Lead Sponsor
- Hannover Medical School
- Brief Summary
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)
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 1080
- Transthoracic echocardiography indicates pulmonary hypertension
- Patients with clinical suspicion for CTEPH, scheduled for SPECT
- Provided informed consent for the study
- Age >18y
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Hannover Medical School
🇩🇪Hannover, Lower Saxony, Germany