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Active, Not Recruiting

NCT Number: NCT05703763

The Applanation Tonometry in GCA Pilot

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?

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Giant Cell Arteritis Arteritis Autoimmune Diseases Autoimmune Diseases of the Nervous System Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Disease Immune System Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin and Connective Tissue Diseases Vascular Diseases Vasculitis Vasculitis, Central Nervous System

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J1C5, Canada

About this study

ATOM-GCA is a single-center, cross-sectional vanguard study.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

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.

Treatment and study plan

Applanation tonometry

Diagnostic Test

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

Standardized GCA assessment

Diagnostic Test

Clinical assessment, blood test review, high-resolution temporal artery ultrasound using a 24mHz probe.

Repeat applanation tonometry (optional)

Diagnostic Test

Repeat index test at month 6 and at disease relapse.

Primary outcomes

  1. 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

  1. Diagnostic performance of the PWV

    Time frame: 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 outcomes

  1. Proportion of participants who accept repeat applanation tonometry

    Time frame: 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.

  2. Proportion of participants who complete repeated applanation tonometry

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Centre Integre Universitaire de Sante et Services Sociaux du Nord de l'ile de Montreal

Other

Registry information

Official study title

The Applanation Tonometry in Giant Cell Arteritis Pilot

Acronym: ATOM-GCA

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 30, 2023
Registry last updated
Aug 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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