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UnknownNCT04010097

Chewing Gum Test for the Diagnosis of Giant Cell Arteritis (Horton's Disease) - ChewingHort

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
66 (estimated)
Sponsor
University Hospital, Limoges · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERchewing gumThe test involves chewing a chewing gum for 4 minutes

Timeline

Start date
2019-10-30
Primary completion
2022-01-01
Completion
2022-01-01
First posted
2019-07-08
Last updated
2021-11-17

Locations

6 sites across 1 country: France

Source: ClinicalTrials.gov record NCT04010097. Inclusion in this directory is not an endorsement.