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The Applanation Tonometry in GCA Pilot

Study acronym: ATOM-GCA
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated August 7, 2025 (before its estimated June 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary endpoint revisedv5 Show 7 more changesShow less
    • Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Primary completion date: Oct 2026 to Jun 2026
    • Study completion date: Mar 2027 to Jul 2027
    • Start date changed from estimate of Jan 2026 to Jul 30, 2025
    • Eligibility criteria expanded, about 68 words
    • Secondary endpoint revised
    • Site contact updated
  2. Primary endpoint revisedv4 Show 4 more changesShow less
    • Enrollment target: 120 to 146
    • Interventions: Applanation tonometry (Diagnostic Test), Standardized GCA assessment (Diagnostic Test) to Applanation tonometry (Diagnostic Test), Repeat applanation tonometry (optional) (Diagnostic Test), Standardized GCA assessment (Diagnostic…
    • Secondary endpoint revised
    • Study description revised
  3. Enrollment target: 200 to 120v3 Show 11 more changesShow less
    • Primary completion date: Aug 2025 to Oct 2026
    • Start date: Mar 2024 to Jan 2026
    • Primary endpoints: 2 to 1
    • Study completion date: Aug 2027 to Mar 2027
    • Interventions: Applanation tonometry (Diagnostic Test) to Applanation tonometry (Diagnostic Test), Standardized GCA assessment (Diagnostic Test)
    • Eligibility criteria shortened, about 18 words
    • Secondary endpoint revised
    • Study description shortened, about 92 words
    • Site contact updated
    • Study arms: 0 to 2
    • Study title shortened, about 3 words
  4. Start date: Jun 2023 to Mar 2024v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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?
Trial Details
NCT Number NCT05703763
Lead Sponsor Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal
Conditions
(from sponsor)		 Giant Cell Arteritis
Related terms Disease, Giant Cell Arteritis
Enrollment 146 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov