CTEPH DIAGNOSIS Europe - MRI

Hannover Medical School (MHH)

Status and phase: Unknown; Phase 3

Conditions: Pulmonary Hypertension

Treatments: Other: Index test: functional dynamic contrast enhanced (DCE)-MRI

Study type: Interventional

Funder types: Other

Identifiers

NCT02791282

CHANGE-MRI

Details and patient eligibility

About

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)

Full 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.

Enrollment: 1,080 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,080 participants in 1 patient group

Index test: functional dynamic contrast enhanced (DCE)-MRI

Other group

Description:

Patients with clinical suspicion for CTEPH, scheduled for SPECT

Treatment:

Other: Index test: functional dynamic contrast enhanced (DCE)-MRI