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

NCT ID: NCT02473029

Last Updated: 2018-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

45 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-06-30

Brief Summary

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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

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Conditions

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Horton Disease

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cases

Patients admitted to a tertiary hospital, with a clinical suspicion of Horton disease

Vascular tomodensitometry

Intervention Type RADIATION

Magnetic resonance angiography

Intervention Type OTHER

Vascular ultrasonography

Intervention Type OTHER

Retinal angiography

Intervention Type OTHER

Retinal optical coherence tomography

Intervention Type OTHER

Interventions

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Vascular tomodensitometry

Intervention Type RADIATION

Magnetic resonance angiography

Intervention Type OTHER

Vascular ultrasonography

Intervention Type OTHER

Retinal angiography

Intervention Type OTHER

Retinal optical coherence tomography

Intervention Type OTHER

Eligibility Criteria

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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...
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fondation Ophtalmologique A. de Rotchschild

Paris, , France

Site Status

Countries

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France

Other Identifiers

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GEL_2014_01

Identifier Type: -

Identifier Source: org_study_id