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Diagnostic Study of Temporal Arteritis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Tel-Aviv Sourasky Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier:
NCT01130857
First received: May 25, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

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.


Condition
Temporal Arteritis

Study Type: Observational
Study Design: Observational Model: Case-Only
Official Title: Diagnostic Tools in Temporal Arteritis - Towards the Development of a Diagnostic Algorithm

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • Percent decrease in future biopsy use. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • No secondary outcome. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: July 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Inpatients suspected of temporal arteritis and referred to temporal artery biopsy

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01130857

Contacts
Contact: Israel SA Heller, MD +97236973375/6 heller@tasmc.health.gov.il
Contact: Ioni Tsechori, MD

Sponsors and Collaborators
Tel-Aviv Sourasky Medical Center
Investigators
Principal Investigator: Israel SA Heller, MD Tel Aviv Medical Center, Tel Aviv, ISRAEL
  More Information

No publications provided

Responsible Party: Israel Heller MD, Israel Heller MD, Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01130857     History of Changes
Other Study ID Numbers: 0123-09-TLV
Study First Received: May 25, 2010
Last Updated: May 25, 2010
Health Authority: Ethics Commission, Tel Aviv Sourasky Medical Center, Tel Aviv, ISRAEL:

Additional relevant MeSH terms:
Giant Cell Arteritis
Arteritis
Vascular Diseases
Cardiovascular Diseases
Vasculitis
Vasculitis, Central Nervous System
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Skin Diseases, Vascular
Skin Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013