The Applanation Tonometry in GCA Pilot
ATOM-GCA
1 other identifier
observational
146
1 country
1
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:
- 3.A clinical diagnosis of GCA (based on pre-defined criteria 6 months after inclusion)?
- 4.Inflammation of temporal arteries on high-resolution ultrasound?
- 5.What is the acceptability and adherence of repeat applanation tonometry during the follow-up period in patients with GCA?
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jul 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 17, 2023
CompletedFirst Posted
Study publicly available on registry
January 30, 2023
CompletedStudy Start
First participant enrolled
July 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
August 7, 2025
July 1, 2025
10 months
January 17, 2023
August 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline
Secondary Outcomes (1)
Diagnostic performance of the PWV
Baseline
Other Outcomes (2)
Proportion of participants who accept repeat applanation tonometry
Baseline
Proportion of participants who complete repeated applanation tonometry
Up to 2 years
Study Arms (2)
GCA group
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.
Non-GCA group
Participants who do not meet the criteria (above) for GCA at month 6.
Interventions
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
Clinical assessment, blood test review, high-resolution temporal artery ultrasound using a 24mHz probe.
Repeat index test at month 6 and at disease relapse.
Eligibility Criteria
Consecutive patients referred for suspected new-onset GCA
You may qualify if:
- To be included in ATOM-GCA, participants must meet all the following criteria:
- Age \> 50 years.
- Referral for suspected, new-onset GCA.
- Ability to understand and willingness to sign an informed consent form.
- Willingness to comply with study visits and procedures.
You may not qualify if:
- An individual who meets any of these criteria will be excluded from ATOM-GCA:
- Referral for a suspected GCA relapse.
- Current use of systemic glucocorticoids, with the following duration at the baseline visit:
- ≥ 14 consecutive days of oral glucocorticoids in the previous 30 days, or
- ≥ 7 consecutive days of oral glucocorticoids if intravenous glucocorticoids were administered in the previous 30 days.
- Current use of any conventional or biologic immunosuppressive therapy.
- Temporal artery biopsy prior to the study visit.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, H4J1C5, Canada
Related Publications (2)
Zarka F, Rheaume M, Belhocine M, Goulet M, Febrer G, Mansour AM, Troyanov Y, Starnino T, Meunier RS, Chagnon I, Routhier N, Benard V, Ducharme-Benard S, Ross C, Makhzoum JP. Colour Doppler ultrasound and the giant cell arteritis probability score for the diagnosis of giant cell arteritis: a Canadian single-centre experience. Rheumatol Adv Pract. 2021 Nov 10;5(3):rkab083. doi: 10.1093/rap/rkab083. eCollection 2021.
PMID: 34859177BACKGROUNDBaalbaki H, Jalaledin D, Lachance C, Febrer G, Rheaume M, Makhzoum JP. Characterization of visual manifestations and identification of risk factors for permanent vision loss in patients with giant cell arteritis. Clin Rheumatol. 2021 Aug;40(8):3207-3217. doi: 10.1007/s10067-021-05643-5. Epub 2021 Feb 12.
PMID: 33580374BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Jean-Paul Makhzoum
CISSS du Nord-de-l'ile de Montreal
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director - Vasculitis Research Program, Principal Investigator
Study Record Dates
First Submitted
January 17, 2023
First Posted
January 30, 2023
Study Start
July 30, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
July 1, 2027
Last Updated
August 7, 2025
Record last verified: 2025-07