The Applanation Tonometry in GCA Pilot (ATOM-GCA)

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Status: Active, not recruiting

Conditions: Giant Cell Arteritis

Treatments: Diagnostic Test: Standardized GCA assessment; Diagnostic Test: Repeat applanation tonometry (optional); Diagnostic Test: Applanation tonometry

Study type: Observational

Funder types: Other

Identifiers

NCT05703763

2020-1890

Details and patient eligibility

About

The Applanation Tonometry in Giant Cell Arteritis (ATOM-GCA) study will answer the following questions:

1. How does PWV, measured by applanation tonometry of temporal arteries, differ between patients with and without a final diagnosis of GCA (based on pre-defined criteria 6 months after inclusion)?

2. What is the diagnostic accuracy and positivity cutoff of the PWV, measured by applanation tonometry, in detecting:

   1. A clinical diagnosis of GCA (based on pre-defined criteria 6 months after inclusion)?
   2. Inflammation of temporal arteries on high-resolution ultrasound?

3. What is the acceptability and adherence of repeat applanation tonometry during the follow-up period in patients with GCA?

Full description

ATOM-GCA is a single-center, cross-sectional vanguard study.

Enrollment: 146 estimated patients

Sex: All

Ages: 50 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

To be included in ATOM-GCA, participants must meet all the following criteria:

1. Age > 50 years.
2. Referral for suspected, new-onset GCA.
3. Ability to understand and willingness to sign an informed consent form.
4. Willingness to comply with study visits and procedures.

Exclusion criteria

An individual who meets any of these criteria will be excluded from ATOM-GCA:

1. Referral for a suspected GCA relapse.

2. Current use of systemic glucocorticoids, with the following duration at the baseline visit:

   1. ≥ 14 consecutive days of oral glucocorticoids in the previous 30 days, or
   2. ≥ 7 consecutive days of oral glucocorticoids if intravenous glucocorticoids were administered in the previous 30 days.

3. Current use of any conventional or biologic immunosuppressive therapy.

4. Temporal artery biopsy prior to the study visit.

Trial design

146 participants in 2 patient groups

GCA group

Description:

Definite confirmation of GCA will occur 6 months after study inclusion, following the phone follow-up, and will require all the following features: 1) initial symptoms and clinical evolution consistent with GCA; 2) at least one positive test for cranial GCA (ultrasound of temporal arteries, temporal artery biopsy, cranial MRI, cranial PET); and 3) satisfies the 2022 ACR-EULAR classification criteria for GCA.

Treatment:

Diagnostic Test: Applanation tonometry

Diagnostic Test: Repeat applanation tonometry (optional)

Diagnostic Test: Standardized GCA assessment

Non-GCA group

Description:

Participants who do not meet the criteria (above) for GCA at month 6.

Treatment:

Diagnostic Test: Applanation tonometry

Diagnostic Test: Standardized GCA assessment