Giant Cell Arteritis
Conditions
Keywords
diagnosis
Brief summary
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?
Detailed description
ATOM-GCA is a single-center, cross-sectional vanguard study.
Interventions
DIAGNOSTIC_TESTApplanation tonometry
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
DIAGNOSTIC_TESTStandardized GCA assessment
Clinical assessment, blood test review, high-resolution temporal artery ultrasound using a 24mHz probe.
DIAGNOSTIC_TESTRepeat applanation tonometry (optional)
Repeat index test at month 6 and at disease relapse.
Sponsors
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 99 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PWV in patients with and without GCA | Baseline | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diagnostic performance of the PWV | Baseline | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of participants who accept repeat applanation tonometry | Baseline | In patients with GCA, we will evaluate the acceptability of applanation tonometry by measuring the proportion of participants who, at the baseline visit, consent to undergo repeated applanation tonometry during the follow-up period. |
| Proportion of participants who complete repeated applanation tonometry | Up to 2 years | The adherence of repeat applanation tonometry (proportion of patient who successfully complete applanation tonometry at month 6 and at relapse) will be assessed in those who consented to have repeat applanation tonometry. |
Countries
Canada
Outcome results
None listed