Velocimetric Study of Temporal Arteries in Patients With... | NCT03360162

Studies
Velocimetric Study of Temporal Arteries in Patients With Horton Disease Using Scan-Doppler

NCT03360162

Sponsor

University Hospital, Brest

Status

Completed

Last Update Posted

Apr 21, 2020Actual

Enrollment

46Actual

Phase

Not provided

Conditions

Horton Disease

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

Apr 2020

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

Nov 2, 2017Actual

Primary Completion Date

Dec 10, 2017Actual

Completion Date

Dec 10, 2017Actual

First Submitted Date

Nov 28, 2017

First Submission Date that Met QC Criteria

Nov 28, 2017

First Posted Date

Dec 4, 2017Actual

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

Apr 20, 2020

Last Update Posted Date

Apr 21, 2020Actual

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

The use of ultrasonography in detecting giant cell arteritis ( GCA) is emerging. Currently, temporal biopsy is the gold standard to diagnose GCA but studies have shown the interest to use B mode ultrasonography. However, until now, the study of velocities in GCA have not been yet performed.

Detailed Description

Not provided

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

46Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Velocimetric Study of Temporal Arteries in Patients With Horton Disease Using Scan-Doppler	velocimetric temporal arterial study in giant arteritis	2 months

Secondary Outcomes

Measure	Description	Time Frame
evaluation of the halo sign in giant arteritis using B mode ultrasonography	presence or absence of the halo sign in giant arteritis patients	2 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients with suspicious giant arteritis

Exclusion Criteria:

patients who have already been treated or diagnosed for giant arteritis

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

all patients aged more than 55 years old who are suspected of giant arteritis

Sampling Method

Probability Sample

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

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