CTEPH DIAGNOSIS Europe - MRI
CHANGE-MRI (CTEPH DIAGNOSIS Europe - MRI)
1 other identifier
interventional
1,080
1 country
1
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started May 2016
Typical duration for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2020
CompletedJune 6, 2016
June 1, 2016
3.8 years
June 1, 2016
June 1, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
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
Study Arms (1)
Index test: functional dynamic contrast enhanced (DCE)-MRI
OTHERPatients with clinical suspicion for CTEPH, scheduled for SPECT
Interventions
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
Eligibility Criteria
You may qualify if:
- Transthoracic echocardiography indicates pulmonary hypertension
- Patients with clinical suspicion for CTEPH, scheduled for SPECT
- Provided informed consent for the study
- Age \>18y
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hannover Medical Schoollead
- University of Sheffieldcollaborator
- University of Giessencollaborator
- Ludwig-Maximilians - University of Munichcollaborator
- Heidelberg Universitycollaborator
Study Sites (1)
Hannover Medical School
Hanover, Lower Saxony, 30625, Germany
Related Publications (1)
Lasch F, Karch A, Koch A, Derlin T, Voskrebenzev A, Alsady TM, Hoeper MM, Gall H, Roller F, Harth S, Steiner D, Krombach G, Ghofrani HA, Rengier F, Heussel CP, Grunig E, Beitzke D, Hacker M, Lang IM, Behr J, Bartenstein P, Dinkel J, Schmidt KH, Kreitner KF, Frauenfelder T, Ulrich S, Hamer OW, Pfeifer M, Johns CS, Kiely DG, Swift AJ, Wild J, Vogel-Claussen J. Comparison of MRI and VQ-SPECT as a Screening Test for Patients With Suspected CTEPH: CHANGE-MRI Study Design and Rationale. Front Cardiovasc Med. 2020 Apr 9;7:51. doi: 10.3389/fcvm.2020.00051. eCollection 2020.
PMID: 32328500DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jens Vogel-Claussen, MD
Hannover Medical School
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2016
First Posted
June 6, 2016
Study Start
May 1, 2016
Primary Completion
March 1, 2020
Study Completion
June 1, 2020
Last Updated
June 6, 2016
Record last verified: 2016-06
Data Sharing
- IPD Sharing
- Will not share