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van CCT (UK)


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Usefulness of the temporal artery biopsy


- candidate number17534
- NTR NumberNTR4529
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-apr-2014
- Secondary IDsW13_301 #13.17.0371 METC AMC
- Public TitleUsefulness of the temporal artery biopsy
- Scientific TitleClinical implications of the temporal artery biopsy
- ACRONYM
- hypothesisThe temporal artery biopsy has no additional value after a halo sign using ultrasound of the temporal artery
- Healt Condition(s) or Problem(s) studiedArteriitis temporalis, Giant cell arteritis
- Inclusion criteriaAll persons referred to the surgical department for a temporal artery biopsy
- Exclusion criteriaNone
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupFactorial
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-apr-2014
- planned closingdate1-apr-2017
- Target number of participants120
- InterventionsAn ultrasound of the temporal artery is performed prior to the biopsy.
- Primary outcome1. To show the additional value of an temporal artery ultrasound and its ability to avoid unnecessary temporal artery biopsies.
2. Potential cost reduction by application of a novel clinical tool.
- Secondary outcomeTo provide a novel clinical tool when to perform a temporal artery biopsy after a temporal artery ultrasound.
- TimepointsDay 0: temporal artery ultrasound and biopsy.
Day 14: Clinical and pathological outcome of the biopsy, potential complications of the biopsty.
Day 84: Long-term complications of the temporal artery biopsy.
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. Dr. I.C.J.H. Post
- CONTACT for SCIENTIFIC QUERIESMD. Dr. I.C.J.H. Post
- Sponsor/Initiator Spaarne Hospital
- Funding
(Source(s) of Monetary or Material Support)
Spaarne Hospital
- Publications
- Brief summaryTemporal arteritis is a disease involving the middle- and greater arteries of the human body. The golden standard for diagnosis is a temporal artery biopsy.
However, novel insights suggest that using ultrasound it is possible to diagnose arteritis temporalis without performing a biopsy with its potential complications.
We intend to correlate the outcome of the ultrasound with the biopsy in order to formulate a clinical tool that can indicate when a biopsy can be avoided in the presence of a positive ultrasound.
- Main changes (audit trail)
- RECORD20-apr-2014 - 13-mei-2014


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