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

Terminated

• Conditions: Horton Disease
• Interventions: Radiation: Vascular tomodensitometry; Other: Magnetic resonance angiography; Other: Vascular ultrasonography; Other: Retinal angiography; Other: Retinal optical coherence tomography

• Registration Number: NCT02473029
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-12
• Study First Submitted: 2015-06-12
• Study First Submitted QC: 2015-06-15
• Study First Posted: 2015-06-16
• Primary Completion: 2018-06
• Study Completion: 2018-06
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-18
• Last Update Posted: 2018-12-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 45

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cases	Vascular ultrasonography	Patients admitted to a tertiary hospital, with a clinical suspicion of Horton disease
Cases	Magnetic resonance angiography	Patients admitted to a tertiary hospital, with a clinical suspicion of Horton disease
Cases	Retinal optical coherence tomography	Patients admitted to a tertiary hospital, with a clinical suspicion of Horton disease
Cases	Vascular tomodensitometry	Patients admitted to a tertiary hospital, with a clinical suspicion of Horton disease
Cases	Retinal angiography	Patients admitted to a tertiary hospital, with a clinical suspicion of Horton disease

Primary Outcome Measures

Name	Time	Method
MRI angiography mural inflammation	Baseline	Presence of signs of artery mural inflammation in T1 sequence of MRI angiography

Trial Locations

Locations (1)

Fondation Ophtalmologique A. de Rotchschild; 🇫🇷 Paris, France