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CTEPH DIAGNOSIS Europe - MRI

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ClinicalTrials.gov Identifier: NCT02791282
Recruitment Status : Recruiting
First Posted : June 6, 2016
Last Update Posted : June 6, 2016
Sponsor:
Collaborators:
University of Sheffield
University of Giessen
Ludwig-Maximilians - University of Munich
Heidelberg University
Information provided by (Responsible Party):
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)

Condition or disease Intervention/treatment Phase
Pulmonary Hypertension Other: Index test: functional dynamic contrast enhanced (DCE)-MRI Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1080 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: CHANGE-MRI (CTEPH DIAGNOSIS Europe - MRI)
Study Start Date : May 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Index test: functional dynamic contrast enhanced (DCE)-MRI
Patients with clinical suspicion for CTEPH, scheduled for SPECT
Other: 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




Primary Outcome Measures :
  1. 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 [ Time Frame: 6 months ]
  2. The proportion of patients with positive MRI in the group of patients with negative VQ-SPECT who are negative in the gold standard [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02791282


Contacts
Contact: Jens Vogel-Claussen, MD +49 511 5323421 vogel-claussen.jens@mh-hannover.de

Locations
Germany
Hannover Medical School Recruiting
Hannover, Lower Saxony, Germany, 30625
Contact: Jens Vogel-Claussen, MD    +49 5115323421    vogel-claussen.jens@mh-hannover.de   
Sponsors and Collaborators
Hannover Medical School
University of Sheffield
University of Giessen
Ludwig-Maximilians - University of Munich
Heidelberg University
Investigators
Principal Investigator: Jens Vogel-Claussen, MD Hannover Medical School

Additional Information:
Responsible Party: Hannover Medical School
ClinicalTrials.gov Identifier: NCT02791282     History of Changes
Other Study ID Numbers: CHANGE-MRI
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Hannover Medical School:
Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
MRI
SPECT

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases