Horton DiseaseHORTIMNCT02473029
Interest of Medical Imaging in the Diagnostic Strategy Vis a Vis a Suspected Horton Disease
An observational study of Horton Disease, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Horton Disease
- What is being tested?
- Vascular tomodensitometry, Magnetic resonance angiography and Vascular ultrasonography
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteFrance
- Study dates
- Dec 2014to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to the Fondation Ophtalmologique Adolphe de Rothschild with a suspected Horton disease
Who may be able to join
- 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.
Who cannot join
- 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...
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Vascular tomodensitometry, Magnetic resonance angiography, Vascular ultrasonography, Retinal angiography, Retinal optical coherence tomography
- Medical subject headings
- Giant Cell Arteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vascular tomodensitometryRadiation
Magnetic resonance angiographyOther
Vascular ultrasonographyOther
Retinal angiographyOther
Retinal optical coherence tomographyOther
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients admitted to a tertiary hospital, with a clinical suspicion of Horton disease Receives: Radiation: Vascular tomodensitometry; Other: Magnetic resonance angiography; Other: Vascular ultrasonography; Other: Retinal angiography; Other: Retinal optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI angiography mural inflammation
Presence of signs of artery mural inflammation in T1 sequence of MRI angiography
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2015 (estimated)
- Study startDec 2014
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Horton DiseaseStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02473029
- Sponsor's protocol ID
- GEL_2014_01
- Acronym
- HORTIM
- Status last verified
- Dec 2018
- First submitted
- 12 Jun 2015
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interest of Medical Imaging in the Diagnostic Strategy Vis a Vis a Suspected Horton Disease
- ClinicalTrials.gov ID
- NCT02473029
- Acronym / sponsor ID
- HORTIM / GEL_2014_01
- Conditions
- Horton Disease
- Study type
- Observational
- Recruitment status
- Terminated
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Dec 2014 (actual)
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 16 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Radiation: Vascular tomodensitometry, Other: Magnetic resonance angiography, Other: Vascular ultrasonography, Other: Retinal angiography, Other: Retinal optical coherence tomographyPatients admitted to a tertiary hospital, with a clinical suspicion of Horton disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to the Fondation Ophtalmologique Adolphe de Rothschild with a suspected Horton disease
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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...
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vascular tomodensitometry | Radiation | Cases |
| Magnetic resonance angiography | Other | Cases |
| Vascular ultrasonography | Other | Cases |
| Retinal angiography | Other | Cases |
| Retinal optical coherence tomography | Other | Cases |
Primary outcome
MRI angiography mural inflammation
Time frame: Baseline
Presence of signs of artery mural inflammation in T1 sequence of MRI angiography
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Horton Disease, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI angiography mural inflammation (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.