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

NCT02473029 | Terminated

• 1 other identifier: GEL_2014_01
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Horton Disease

Outcome Measures

Primary Outcomes (1)

• MRI angiography mural inflammation

  Presence of signs of artery mural inflammation in T1 sequence of MRI angiography

  Baseline

Study Arms (1)

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

Interventions

Vascular tomodensitometry RADIATION

Cases

Magnetic resonance angiography OTHER

Cases

Vascular ultrasonography OTHER

Cases

Retinal angiography OTHER

Cases

Retinal optical coherence tomography OTHER

Cases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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...

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation Ophtalmologique A. de Rotchschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous System; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteritis; Vasculitis; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2015
• First Posted: June 16, 2015
• Study Start: December 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: December 19, 2018

Record last verified: 2018-12

Locations

FR (1)