Diagnostic Study of Temporal Arteritis

Temporal Arteritis Clinical Trial

Official title:

Diagnostic Tools in Temporal Arteritis - Towards the Development of a Diagnostic Algorithm

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01130857
• Other study ID #: 0123-09-TLV
• Status: Not yet recruiting
• Phase: N/A
• First received: May 25, 2010
• Last updated: May 25, 2010
• Start date: July 2010
• Est. completion date: July 2012

Study information

• Verified date: January 2010
• Source: Tel-Aviv Sourasky Medical Center
• Contact: Israel SA Heller, MD
• Phone: +97236973375/6
• Email: heller[@]tasmc.health.gov.il
• Is FDA regulated: No
• Health authority: Ethics Commission, Tel Aviv Sourasky Medical Center, Tel Aviv, ISRAEL:
• Study type: Observational

Clinical Trial Summary

Despite a large and growing body of knowledge concerning the diagnosis of temporal arteritis, this potentially crippling disease still requires pathological diagnosis in practically every case. It seems likely that a correctly estimated clinical probability could help in evaluating imaging results in a way that might safely obviate temporal biopsy in a large segment of suspect cases.

With this aim in view, we intend to identify useful clinical items and integrate them in an appropriate diagnostic pathway.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2012
• Est. primary completion date: March 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients suspected of temporal arteritis and referred by their physicians to biopsy of a temporal artery.

Exclusion Criteria:

• Pregnancy; age > 80 or < 18; unable to answer study questions

Study Design

Observational Model: Case-Only

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Temporal Arteritis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent decrease in future biopsy use.		2 years	No
Secondary	No secondary outcome.		2 years	No