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

Horton Disease Clinical Trial

— HORTIM  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02473029
• Other study ID #: GEL_2014_01
• Status: Terminated
• Start date: December 2014
• Est. completion date: June 2018

Study information

• Verified date: December 2018
• Source: Fondation Ophtalmologique Adolphe de Rothschild
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 45
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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...

Related Conditions & MeSH terms

• Giant Cell Arteritis
• Horton Disease
• Polymyalgia Rheumatica

Intervention

Radiation:
• Vascular tomodensitometry

Other:
• Magnetic resonance angiography

• Vascular ultrasonography

• Retinal angiography

• Retinal optical coherence tomography

Locations

Country	Name	City	State
France	Fondation Ophtalmologique A. de Rotchschild	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Fondation Ophtalmologique Adolphe de Rothschild

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	MRI angiography mural inflammation	Presence of signs of artery mural inflammation in T1 sequence of MRI angiography	Baseline