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NCT02791282 | SNCTP000003483

Untersuchung der chronisch thrombotischen pulmonalen Hypertension mittels der Magnetresonanztomographie.

Data source: BASEC (Imported from 16.10.2019), WHO (Imported from 13.10.2019)
Changed: 09.10.2019
Disease category: Anderes, Atemwegserkrankungen (nicht Krebs)

Brief description of trial (Source of data: 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 (Source of data: BASEC)

Chronisch thrombotische pulmonale Hypertension

Health conditions (Source of data: WHO)

Pulmonary Hypertension

Rare disease (Source of data: BASEC)

No

Intervention investigated (e.g. drug, therapy or campaign) (Source of data: BASEC)

Es wird untersucht ob die strahlungsfreie Magnetresonanztomographie (MRT) ähnlich sensitive Ergebnisse zur Diagnose der chronisch thromoembolischen pulmonalen Hypertension (CTEPH) liefern kann.

Interventions (Source of data: WHO)

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

Criteria for participation in trial (Source of data: BASEC)

Verdacht auf eine pulmonale Hypertonie welche bereits für eine klinisch indizierte SPECT Untersuchung angemeldet sind
Volljährigkeit
Einverständnis

Exclusion criteria (Source of data: BASEC)

Unvermögen der Durchführung einer MRT (Platzangst, nicht MRI taugliche Installationen)
Unverträglichkeit gegen MRT-Kontrastmittel
Schwangerschaft und Stillzeit

Inclusion/Exclusion Criteria (Source of data: 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 the trial in WHO primary registry

https://clinicaltrials.gov/show/NCT02791282

Further information on the trial from WHO database (ICTRP)

http://apps.who.int/trialsearch/Trial2.aspx?TrialID=NCT02791282

Further information on trial

Date trial registered

01.06.2016

Incorporation of the first participant

01.05.2016

Recruitment status

Recruiting

Academic title (Source of data: WHO)

CHANGE-MRI (CTEPH DIAGNOSIS Europe - MRI)

Type of trial (Source of data: WHO)

Interventional

Design of the trial (Source of data: WHO)

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Phase (Source of data: WHO)

Phase 3

Primary end point (Source of data: 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 (Source of data: WHO)

Please refer to primary and secondary sponsors

Trial sites

Trial sites in Switzerland (Source of data: BASEC)

Hannover, Heidelberg, Mainz, Marburg, München, Regensburg, Sheffield, Vienna, Zürich

Countries (Source of data: WHO)

Germany

Contact for further information on the trial

Details of contact in Switzerland (Source of data: BASEC)

Thomas Frauenfelder
+41 44 255 93 83
thomas.frauenfelder@usz.ch

Contact for general information (Source of data: WHO)

Jens Vogel-Claussen, MD
Hannover Medical School
+49 511 5323421;+49 5115323421
vogel-claussen.jens@mh-hannover.de

Contact for scientific information (Source of data: WHO)

Jens Vogel-Claussen, MD
Hannover Medical School
+49 511 5323421;+49 5115323421
vogel-claussen.jens@mh-hannover.de

Principal Sponsor/Investigator

Principal sponsor (Source of data: WHO)

Hannover Medical School

Additional sponsors (Source of data : WHO)

University of Sheffield;University of Giessen;Ludwig-Maximilians - University of Munich;Heidelberg University

Further trial identification numbers

BASEC ID (Source of data: BASEC)

2019-01069

Secondary ID (Source of data: WHO)

CHANGE-MRI