NCT01130857

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2010

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 26, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
Last Updated

May 26, 2010

Status Verified

January 1, 2010

Enrollment Period

1.7 years

First QC Date

May 25, 2010

Last Update Submit

May 25, 2010

Conditions

Temporal Arteritis

Outcome Measures

Primary Outcomes (1)

  • Percent decrease in future biopsy use.

    2 years

Secondary Outcomes (1)

  • No secondary outcome.

    2 years

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients suspected of temporal arteritis and referred to temporal artery biopsy

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous SystemAutoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Israel SA Heller, MD

    Tel Aviv Medical Center, Tel Aviv, ISRAEL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Israel SA Heller, MD

CONTACT

+97236973375/6heller@tasmc.health.gov.il

Ioni Tsechori, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

May 25, 2010

First Posted

May 26, 2010

Study Start

July 1, 2010

Primary Completion

March 1, 2012

Study Completion

July 1, 2012

Last Updated

May 26, 2010

Record last verified: 2010-01