The Applanation Tonometry in GCA Pilot

Not yet recruiting

• Conditions: Giant Cell Arteritis

• Registration Number: NCT05703763
• Lead Sponsor: Hopital du Sacre-Coeur de Montreal

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.

Study Timeline

• Study First Submitted: 2023-01-17
• Study First Submitted QC: 2023-01-26
• Study First Posted: 2023-01-30
• Status Verified: 2024-10
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-04
• Study Start: 2026-01
• Primary Completion: 2026-10
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 146

Inclusion Criteria

1. adult patient aged > 50 years;
2. referred for suspected, new-onset or relapsing cranial GCA;
3. ability to understand and willingness to sign a written informed consent form.

Exclusion Criteria

1. they had a temporal artery biopsy prior to the study visit;
2. they used systemic glucocorticoids for ≥ 14 consecutive days in the previous 30 days.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean PWV in patients with GCA to the mean PWV in individuals without GCA.	Baseline	Repeated measures in PWV (n=4 for each participant)

Secondary Outcome Measures

Name	Time	Method
Diagnostic performance of the PWV to predict the presence of GCA-induced inflammation on high-resolution ultrasound	Baseline	1. Repeated measures in PWV (n=4 for each participant).; 2. For each participant, branches (n=4) of temporal artery will be characterized by the absence/presence of inflammation based on predefined validated positivity thresholds on high-resolution ultrasound.

Trial Locations

Locations (1)

Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal; 🇨🇦 Montreal, Quebec, Canada