The Applanation Tonometry in GCA Pilot

N/AActive Not RecruitingNCT05703763

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal146 enrolled

Overview

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?

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

Study Type

OBSERVATIONAL

Enrollment

146

Conditions

Giant Cell Arteritis

Interventions

Applanation tonometryDIAGNOSTIC_TEST

Applanation tonometry will be used to measure arterial stiffness in these segments, bilaterally: * Superficial temporal artery to frontal temporal artery * Common carotid artery to superficial temporal artery

Eligibility

Sex: ALLMin age: 50 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

PWV in patients with and without GCA

The primary outcome of ATOM-GCA is to compare the mean PWV in patients with GCA to the mean PWV in individuals without GCA. Final confirmation of GCA will be determined 6 months after study inclusion. This analysis will establish whether the PWV differs in GCA. Additionally, we will explore the optimal PWV cutoff and evaluate its diagnostic performance to confirm a final diagnosis of GCA at 6 months.

Time frame: Baseline

Secondary Outcomes

Diagnostic performance of the PWV

The secondary outcome is to assess the diagnostic performance of the PWV to predict the presence of GCA-induced inflammation on high-resolution ultrasound. This analysis will identify the optimal PWV cutoff to potentially replace temporal artery ultrasound in GCA diagnosis.