Clinical trial NCT04010097: Chewing Gum Test for the Diagnosis of Giant Cell Arteritis (Horton's Disease) - ChewingHort
Official title: Evaluation of Sensitivity, Specificity, Positive and Negative Predictive Values of the Chewing Gum Test for the Diagnosis of Giant Cell Arteritis (Horton's Disease) - ChewingHort
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Horton Disease
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2019-07-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: It is hypothesized that chewing-gums may be a useful test to unmask jaws intermittent claudication in order to enhance the diagnosis of Giant Cell Arteritis (GCA).

Detailed description: GCA is the most common vasculitis. The diagnosis easily could be made in patients over 50 years old with headache, inflammatory belt pain, claudication of the jaws, scalp hyperesthesia, ophthalmological manifestations and an inflammatory syndrome. However, the clinical pictures could be less suggestive, hence diagnostic difficulties. Some patients have only isolated inflammatory syndrome. To confirm the diagnosis, sometimes PET CT or temporal artery biopsy is used, but access to a PET CT is sometimes complex, biopsy of temporal arteries is only positive in about 70% cases. Early diagnosis is important, however, to avoid irreversible complications, especially ophthalmological complications. One in six patients has definitive amaurosis, because of diagnosis delay. The current diagnostic delay is estimated on average at 9 weeks.

Jaw intermittent claudication probably has a very good positive predictive value and this clinical sign often carries conviction. Patients with claudication of the jaws also have a greater visual risk. Kuo reports two observations of patients with claudication of the jaws revealed by the "chewing gum test" after 2 minutes of chewing. It is therefore proposed to perform a chewing gum test to assess the sensitivity and specificity of this test, compared to the interview.

Once the test is done, the study is completed for the patient.

Eligibility criteria: Inclusion Criteria:

* Group 1
* Any patient suspected of having GCA, that is to say in practice patients in whom a doctor plans a Doppler ultrasound of temporal arteries or a temporal arteritis biopsy or an imagery (Angio-CT, Angio-MRI, PET- to scan
* Patient over 50 years old
* Patient able to chew a chewing gum for 4 minutes Group 2
* Patients free from GCA
* Age matched (± 3 years)
* Patient able to chew a chewing gum for 4 minutes

Exclusion Criteria:

* Group 1
* Patients known to have a temporomandibular joint pathology
* Patients who started corticosteroid therapy Group 2
* Patients known to have temporomandibular joint pathology
* Patients who started corticosteroid therapy

Primary outcomes:
measure: Evaluate the sensitivity and specificity of the chewing gum test in Horton's disease.
timeFrame: Day 1
Secondary outcomes:
measure: Evaluate the positive predictive value, the negative predictive value, and the likelihood ratio of the chewing gum test in Horton's disease,
timeFrame: Day1
Other outcomes:
Locations:
city: Avignon
country: France
facility: CH Avignon
city: Limoges
country: France
facility: CHU Limoges
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: CH St Antoine
city: Tours
country: France
facility: CHU Tours
city: Valenciennes
country: France
facility: CH Valenciennes
Study officials:
References: