|- candidate number||17534|
|- NTR Number||NTR4529|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||20-apr-2014|
|- Secondary IDs||W13_301 #13.17.0371 METC AMC|
|- Public Title||Usefulness of the temporal artery biopsy|
|- Scientific Title||Clinical implications of the temporal artery biopsy|
|- hypothesis||The temporal artery biopsy has no additional value after a halo sign using ultrasound of the temporal artery|
|- Healt Condition(s) or Problem(s) studied||Arteriitis temporalis, Giant cell arteritis|
|- Inclusion criteria||All persons referred to the surgical department for a temporal artery biopsy|
|- Exclusion criteria||None|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||1-apr-2014|
|- planned closingdate||1-apr-2017|
|- Target number of participants||120|
|- Interventions||An ultrasound of the temporal artery is performed prior to the biopsy.|
|- Primary outcome||1. 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 outcome||To provide a novel clinical tool when to perform a temporal artery biopsy after a temporal artery ultrasound.|
|- Timepoints||Day 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|
|- CONTACT FOR PUBLIC QUERIES||MD. Dr. I.C.J.H. Post|
|- CONTACT for SCIENTIFIC QUERIES||MD. Dr. I.C.J.H. Post|
|- Sponsor/Initiator ||Spaarne Hospital|
(Source(s) of Monetary or Material Support)
|- Brief summary||Temporal 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)|
|- RECORD||20-apr-2014 - 13-mei-2014|