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CTEPH DIAGNOSIS Europe - MRI

Primary Purpose

Pulmonary Hypertension

Status
Unknown status
Phase
Phase 3
Locations
Germany
Study Type
Interventional
Intervention
Index test: functional dynamic contrast enhanced (DCE)-MRI
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Hypertension focused on measuring Chronic Thromboembolic Pulmonary Hypertension (CTEPH), MRI, SPECT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Hannover Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

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

Arm Description

Patients with clinical suspicion for CTEPH, scheduled for SPECT

Outcomes

Primary Outcome Measures

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
The proportion of patients with positive MRI in the group of patients with negative VQ-SPECT who are negative in the gold standard

Secondary Outcome Measures

Full Information

First Posted
June 1, 2016
Last Updated
June 1, 2016
Sponsor
Hannover Medical School
Collaborators
University of Sheffield, University of Giessen, Ludwig-Maximilians - University of Munich, Heidelberg University
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1. Study Identification

Unique Protocol Identification Number
NCT02791282
Brief Title
CTEPH DIAGNOSIS Europe - MRI
Official Title
CHANGE-MRI (CTEPH DIAGNOSIS Europe - MRI)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
May 2016 (undefined)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
June 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hannover Medical School
Collaborators
University of Sheffield, University of Giessen, Ludwig-Maximilians - University of Munich, Heidelberg University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), MRI, SPECT

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1080 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Index test: functional dynamic contrast enhanced (DCE)-MRI
Arm Type
Other
Arm Description
Patients with clinical suspicion for CTEPH, scheduled for SPECT
Intervention Type
Other
Intervention Name(s)
Index test: functional dynamic contrast enhanced (DCE)-MRI
Intervention Description
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 Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jens Vogel-Claussen, MD
Phone
+49 511 5323421
Email
vogel-claussen.jens@mh-hannover.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Vogel-Claussen, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hannover Medical School
City
Hannover
State/Province
Lower Saxony
ZIP/Postal Code
30625
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens Vogel-Claussen, MD
Phone
+49 5115323421
Email
vogel-claussen.jens@mh-hannover.de

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32328500
Citation
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.
Results Reference
derived
Links:
URL
http://change-mri.de
Description
study website

Learn more about this trial

CTEPH DIAGNOSIS Europe - MRI

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