TAAT: Applanation Tonometry in the Diagnosis of Giant Cell Arteritis

Sponsor
Hopital du Sacre-Coeur de Montreal (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05703763
Collaborator
(none)
200
1
50
4

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Applanation tonometry

Detailed 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

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Applanation Tonometry in the Diagnosis and Monitoring of New-Onset Giant Cell Arteritis
Anticipated Study Start Date :
Jun 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2025
Anticipated Study Completion Date :
Aug 1, 2027

Outcome Measures

Primary Outcome Measures

  1. Comparison of arterial striffness of temporal arteries in patients with vs. without new-onset GCA [Baseline]

  2. Comparison of arterial striffness of extra-cranial arteries in patients with vs. without new-onset GCA [Baseline]

Secondary Outcome Measures

  1. 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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years to 95 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vasculitis Clinic, Hopital du Sacre-Coeur de Montreal Montreal Quebec Canada H4J1C5

Sponsors and Collaborators

  • Hopital du Sacre-Coeur de Montreal

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

Responsible Party:
Jean-Paul Makhzoum, Director - Vasculitis Research Program, Principal Investigator, Hopital du Sacre-Coeur de Montreal
ClinicalTrials.gov Identifier:
NCT05703763
Other Study ID Numbers:
  • 2020-1890
First Posted:
Jan 30, 2023
Last Update Posted:
Jan 30, 2023
Last Verified:
Jan 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Jean-Paul Makhzoum, Director - Vasculitis Research Program, Principal Investigator, Hopital du Sacre-Coeur de Montreal
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 30, 2023