Brief description of trial (Data source: BASEC)
Ziel dieser Studie ist, zu untersuchen, ob die strahlungsfreie Magnetresonanztomographie (MRT) im direkten Vergleich mit dem V/Q-Scan bei Diagnose der chronisch thromoembolischen pulmonalen Hypertension (CTEPH) gleichwertig ist, um zukünftig hier auch das MRT in der klinischen Routine anbieten zu können.
Der Ersatz des V/Q-Scan durch die MRT kann letztendlich dazu beitragen, die Strahlenexposition für Patienten mit pulmonaler Hypertonie sowie der gesamten Bevölkerung zu reduzieren.
Health conditions investigated(Data source: BASEC)
Chronisch thrombotische pulmonale Hypertension
Health conditions
(Data source: WHO)
Pulmonary Hypertension
Rare disease
(Data source: BASEC)
No
Intervention investigated (e.g. drug, therapy or campaign)
(Data source: BASEC)
Es wird untersucht ob die strahlungsfreie Magnetresonanztomographie (MRT) ähnlich sensitive Ergebnisse zur Diagnose der chronisch thromoembolischen pulmonalen Hypertension (CTEPH) liefern kann.
Interventions
(Data source: WHO)
Other: Index test: functional dynamic contrast enhanced (DCE)-MRI
Criteria for participation in trial
(Data source: BASEC)
Verdacht auf eine pulmonale Hypertonie welche bereits für eine klinisch indizierte SPECT Untersuchung angemeldet sind
Volljährigkeit
Einverständnis
Exclusion criteria
(Data source: BASEC)
Unvermögen der Durchführung einer MRT (Platzangst, nicht MRI taugliche Installationen)
Unverträglichkeit gegen MRT-Kontrastmittel
Schwangerschaft und Stillzeit
Inclusion/Exclusion Criteria
(Data source: WHO)
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
-
Further information on trial
Date trial registered
Jun 1, 2016
Incorporation of the first participant
May 1, 2016
Recruitment status
Recruiting
Academic title
(Data source: WHO)
CHANGE-MRI (CTEPH DIAGNOSIS Europe - MRI)
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Phase
(Data source: WHO)
Phase 3
Primary end point
(Data source: WHO)
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
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
Trial results
(Data source: WHO)
Results summary
no information available yet
Link to the results in the primary register
no information available yet
Information on the availability of individual participant data
no information available yet
Trial sites
Trial sites in Switzerland
(Data source: BASEC)
Hannover, Heidelberg, Mainz, Marburg, München, Regensburg, Sheffield, Vienna, Zurich
Countries
(Data source: WHO)
Switzerland might not appear as site of trial if it has not yet been entered as such in the WHO primary registry.
Germany
Contact for further information on the trial
Details of contact in Switzerland
(Data source: BASEC)
Thomas Frauenfelder
+41 44 255 93 83
thomas.frauenfelder@usz.ch
Contact for general information
(Data source: WHO)
Jens Vogel-Claussen, MD
Hannover Medical School
+49 511 5323421;+49 5115323421
vogel-claussen.jens@mh-hannover.de
Contact for scientific information
(Data source: WHO)
Jens Vogel-Claussen, MD
Hannover Medical School
+49 511 5323421;+49 5115323421
vogel-claussen.jens@mh-hannover.de
Authorisation by the ethics committee (Data source: BASEC)
Name of the authorising ethics committee (for multicentre studies only the lead committee)
Kantonale
Ethikkommission Zürich
Date of authorisation by the ethics committee
08.10.2019
Further trial identification numbers
Trial identification number of the ethics committee (BASEC-ID)
(Data source: BASEC)
2019-01069
Secondary ID (Data source: WHO)
CHANGE-MRI
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