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The Applanation Tonometry in Giant Cell Arteritis (ATOM-GCA) study will answer the following questions:
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)?
What is the diagnostic accuracy and positivity cutoff of the PWV, measured by applanation tonometry, in detecting:
What is the acceptability and adherence of repeat applanation tonometry during the follow-up period in patients with GCA?
ATOM-GCA is a single-center, cross-sectional vanguard study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Applanation tonometry | Diagnostic Test | Applanation tonometry will be used to measure arterial stiffness in these segments, bilaterally:
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Diagnostic performance of the PWV | 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. | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants who accept repeat applanation tonometry | 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. | Baseline |
| Proportion of participants who complete repeated applanation tonometry |
Inclusion criteria:
To be included in ATOM-GCA, participants must meet all the following criteria:
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:
Current use of any conventional or biologic immunosuppressive therapy.
Temporal artery biopsy prior to the study visit.
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Consecutive patients referred for suspected new-onset GCA
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| Name | Affiliation | Role |
|---|---|---|
| Jean-Paul Makhzoum | CISSS du Nord-de-l'ile de Montreal | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal | Montreal | Quebec | H4J1C5 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34859177 | Background | 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. | |
| 33580374 |
| Label | URL |
|---|---|
| Vasculitis Clinic - University of Montreal | View source |
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| ID | Term |
|---|---|
| D013700 | Giant Cell Arteritis |
| D004194 | Disease |
| ID | Term |
|---|---|
| D020293 | Vasculitis, Central Nervous System |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D002561 | Cerebrovascular Disorders |
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| 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. |
|
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. |
| Up to 2 years |
| Background |
| Baalbaki 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. |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D001167 | Arteritis |
| D014657 | Vasculitis |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |