The Applanation Tonometry in Giant Cell Arteritis Pilot
Overview
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 146
- Locations
- 1
- Primary Endpoint
- PWV in patients with and without GCA
Overview
Brief Summary
The Applanation Tonometry in Giant Cell Arteritis (ATOM-GCA) study will answer the following questions:
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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)?
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What is the diagnostic accuracy and positivity cutoff of the PWV, measured by applanation tonometry, in detecting:
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A clinical diagnosis of GCA (based on pre-defined criteria 6 months after inclusion)?
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Inflammation of temporal arteries on high-resolution ultrasound?
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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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 50 Years to 99 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
PWV in patients with and without GCA
Time Frame: 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 Outcomes
- Diagnostic performance of the PWV(Baseline)
Investigators
Jean-Paul Makhzoum
Director - Vasculitis Research Program, Principal Investigator
Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal