NCT04204512

Brief Summary

Evaluation of the structural features of temporal arteritis using two frequencies probes: 18 and 22Mhz.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

December 17, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 19, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2020

Completed
Last Updated

August 24, 2021

Status Verified

July 1, 2021

Enrollment Period

8 months

First QC Date

December 17, 2019

Last Update Submit

August 23, 2021

Conditions

Keywords

ultrasound,giant cell arteritis

Outcome Measures

Primary Outcomes (2)

  • halo sign of temporal arteritis

    hypoechogenicity of the wall artery

    inclusion

  • compression sign of of temporal arteritis

    persistent of increased inflammatory arteries wall

    inclusion

Secondary Outcomes (5)

  • halo sign of carotid arteritis

    inclusion

  • halo sign of subclavian arteritis

    inclusion

  • halo sign of axillary arteritis

    inclusion

  • other structural abnormalities in unilateral B mode

    inclusion

  • other structural abnormalities in bilateral B mode

    inclusion

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients with suspicion of giant cell arteritis

You may qualify if:

  • sedimentation rate\> 50 mm/h or recent unusual headache or unusual fever, recent visual trouble or jaw claudication, or induration temporal arteritis

You may not qualify if:

  • previous diagnosis of giant cell arteritis and relapse of the giant cell arteritis and opposition to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU de Brest

Brest, 29609, France

Location

MeSH Terms

Conditions

Giant Cell Arteritis

Condition Hierarchy (Ancestors)

Vasculitis, Central Nervous SystemAutoimmune Diseases of the Nervous SystemNervous System DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesArteritisVasculitisSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2019

First Posted

December 19, 2019

Study Start

December 17, 2019

Primary Completion

August 24, 2020

Study Completion

August 24, 2020

Last Updated

August 24, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will share

All collected data that underlie results in a publication

Shared Documents
STUDY PROTOCOL
Time Frame
Data will be available beginning 18 month and ending five years following the end of study
Access Criteria
Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.

Locations