Trials / Unknown
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
| Type | Name | Description |
|---|---|---|
| OTHER | chewing gum | The 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.