CTEPH DIAGNOSIS Europe

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

1080 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-06-30

Brief Summary

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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)

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Detailed Description

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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.

Conditions

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Pulmonary Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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

Patients with clinical suspicion for CTEPH, scheduled for SPECT

Group Type OTHER

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

Intervention Type 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

Interventions

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

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No