Applanation Tonometry in the Diagnosis of Giant Cell Arteritis

Giant Cell Arteritis Clinical Trial

— TAAT  

Official title:

Applanation Tonometry in the Diagnosis and Monitoring of New-Onset Giant Cell Arteritis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05703763
• Other study ID #: 2020-1890
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: August 2027

Study information

• Verified date: September 2023
• Source: Hopital du Sacre-Coeur de Montreal
• Contact: Jean-Paul Makhzoum, MD
• Phone: 514-338-2222
• Email: jean-paul.makhzoum[@]umontreal.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The objective of this observational prospective cohort study is to assess if: 1. temporal artery stiffness measurement by applanation tonometry may help predict a final diagnosis of new-onset GCA 2. In patients with a diagnosis of GCA, identify if temporal artery stiffness measured by applanation tonometry improves with treatment.

Description:

Applanation tonometry (a technique that measures the pulsation of the arteries with a probe, like ultrasound), measures the stiffness of the arteries. This technique is increasingly used for the diagnosis and monitoring of high blood pressure in routine practice. The presence of systemic inflammation, was already demonstrated to cause increased arterial stiffness, at various arterial levels, in rheumatic diseases such as rheumatoid arthritis or Takayasu's arteritis. Objectives : 1. To establish if temporal artery stiffness measurement may help predict a final diagnosis of new-onset GCA 2. In patients with a diagnosis of GCA, identify if temporal artery stiffness improves with treatment

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: August 2027
• Est. primary completion date: August 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 95 Years

Eligibility

Inclusion Criteria:

• Adult patients referred to our fast-track vasculitis clinic with a clinical suspicion of new-onset GCA.
• Must have a duration of glucocorticoid treatment of less than 14 days.
• Must sign informed consent
• Participation must be able to attend a 3 month follow-up visit, and in those with GCA, longitudinal clinic visits

Exclusion Criteria:

• Prior temporal artery biopsy before study enrollment
• Chronic use of immunosupressive therapy or glucocorticoids for more than 14 days

Related Conditions & MeSH terms

• Arteritis
• Giant Cell Arteritis
• Polymyalgia Rheumatica

Intervention

Diagnostic Test:
• Applanation tonometry
Applanation tonometry will be used to measure arterial stiffness in these segments, bilaterally: Superficial temporal artery to frontal temporal artery Superficial temporal artery to parietal temporal artery Common carotid artery to frontal temporal artery Common carotid artery to parietal temporal artery Common carotid artery to femoral artery

Locations

Country	Name	City	State
Canada	Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Hopital du Sacre-Coeur de Montreal

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of arterial striffness of temporal arteries in patients with vs. without new-onset GCA		Baseline
Primary	Comparison of arterial striffness of extra-cranial arteries in patients with vs. without new-onset GCA		Baseline
Secondary	Assessment of variability in arterial stiffness (cranial and extra-cranial) during the course of therapy of patients with GCA		Month 3 and clinical relapse (up to 24 months after study inclusion)

External Links

•   Vasculitis Clinic - University of Montreal