Comparison of 22Mhz and 18Mhz High-frequency Probes for t... | NCT04204512

Studies
Comparison of 22Mhz and 18Mhz High-frequency Probes for the Ultrasound Study of Temporal Arteries in Patients Suspected of Having Giant Cell Arteritis

NCT04204512

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Aug 24, 2021Actual

Enrollment

80Actual

Phase

Not provided

Conditions

Giant Cell Arteritis

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 17, 2019Actual

Primary Completion Date

Aug 24, 2020Actual

Completion Date

Aug 24, 2020Actual

First Submitted Date

Dec 17, 2019

First Submission Date that Met QC Criteria

Dec 17, 2019

First Posted Date

Dec 19, 2019Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 23, 2021

Last Update Posted Date

Aug 24, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Comparison of the results obtained by using 2 different frequencies probes in the diagnosis of giant cell arteritis

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

80Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
halo sign of carotid arteritis	hypoechogenicity of the wall artery	inclusion
halo sign of subclavian arteritis	hypoechogenicity of the wall artery

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

50 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients with suspicion of giant cell arteritis

Sampling Method

Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHRU de Brest		Brest		29609	France

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

All collected data that underlie results in a publication

Types

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.

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013700	Giant Cell Arteritis

Ancestor Terms

ID	Term
D020293	Vasculitis, Central Nervous System
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D002561	Cerebrovascular Disorders

Browse Leaves

Not provided

Browse Branches

Not provided