Interest of Medical Imaging in the Diagnostic Strategy Vis a Vis a Suspected Horton Disease (HORTIM)

December 18, 2018 updated by: Fondation Ophtalmologique Adolphe de Rothschild
The study aims at measuring the sensitivity and specificity of a series of imaging signs (recorded by magnetic resonance angiography, vascular tomodensitometry, vascular ultrasonography, retina angiography and retina optic coherence tomography) for the diagnosis of Horton disease, the gold standard being the result of temporal artery biopsy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75019
        • Fondation Ophtalmologique A. de Rotchschild

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients admitted to the Fondation Ophtalmologique Adolphe de Rothschild with a suspected Horton disease

Description

Inclusion Criteria:

  • Patients admitted to the Fondation Ophtalmologique Adolphe de Rothschild and suspected to suffer from Horton disease, based on the presence of 3 or more major criteria, or 2 major criteria and at least one minor criteria.

Major criteria : Age > 50 ans ; headache ; intermittent jaw or tongue pain ; visual impairment ; ESR > 50 mm at 1h and/or CRP > 8mg/l.

Minor criteria: temporal artery or scalp tenderness ; facial pain or tenderness ; fever >38°C, weight loss >10%, anorexia, fatigue.

Exclusion Criteria:

  • Autoimmune disease
  • Active infectious condition
  • Malignant disease
  • Condition counterindicating one or several of the protocol's imaging procedures : allergy to iodine and/or renal insufficiency and/or claustrophobia and/or metallic foreign body...

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cases
Patients admitted to a tertiary hospital, with a clinical suspicion of Horton disease
Radiation: Vascular tomodensitometry
Other: Magnetic resonance angiography
Other: Vascular ultrasonography
Other: Retinal angiography
Other: Retinal optical coherence tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
MRI angiography mural inflammation
Time Frame: Baseline
Presence of signs of artery mural inflammation in T1 sequence of MRI angiography
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

June 1, 2018

Study Completion (Actual)

June 1, 2018

Study Registration Dates

First Submitted

June 12, 2015

First Submitted That Met QC Criteria

June 15, 2015

First Posted (Estimate)

June 16, 2015

Study Record Updates

Last Update Posted (Actual)

December 19, 2018

Last Update Submitted That Met QC Criteria

December 18, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GEL_2014_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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