BRUSH Sign: Radiolographic Marker of Cerebral Infarctus P... | NCT03467269

Studies
BRUSH Sign: Radiolographic Marker of Cerebral Infarctus Prognosis

NCT03467269

Sponsor

Fondation Hôpital Saint-Joseph

Status

Completed

Last Update Posted

Mar 15, 2018Actual

Enrollment

250Actual

Phase

Not provided

Conditions

Cerebral Infarction

Interventions

Brush sign

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

Mar 2018

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

Feb 24, 2017Actual

Primary Completion Date

Apr 1, 2017Actual

Completion Date

Jun 30, 2017Actual

First Submitted Date

Mar 9, 2018

First Submission Date that Met QC Criteria

Mar 14, 2018

First Posted Date

Mar 15, 2018Actual

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

Mar 14, 2018

Last Update Posted Date

Mar 15, 2018Actual

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

Today the treatment of ischemic stroke in acute phase is based on medicinal or endovascular revascularization. Cerebral MRI sequences help the diagnostic. This procedure uses deoxyhemoglobin as an endogenous tracer. This is also a scorer of cerebral ischemia and the increase lets visualized transcerebral veins in the suffering zone giving a brush aspect. Several studies show the interest of this sign and conclude that deoxyhemoglobin presence is a predictive factor of cerebral ischemia. The aim of the study is to evaluate this brush-sign and correlate it with the prognosis retrospectively.

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

250Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Brush sign	Diagnostic Test	presence of a brush sign in MRI image in acute cerebral ischaemia

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
autonomy level	measurement of autonomy level by mRS	Month 3

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age>18 years old
hospitalized for cerebral infarction
MCA territory
MRI within 24hours
Sequence of magnetic susceptibility (SWAN)

Exclusion Criteria:

Incomplete cerebral infarct
MRI not possible

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patient hospitalized between april 2014 and august 2016 for cerebral infarction

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
ZUBER Mathieu, Professor	GHPSJ	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Groupe Hospitalier Paris Saint Joseph		Paris	Île-de-France Region	75014	France

Condition Browse Module

MeSH Terms

ID	Term
D002544	Cerebral Infarction

Ancestor Terms

ID	Term
D020520	Brain Infarction
D002545	Brain Ischemia
D002561	Cerebrovascular Disorders
D001927	Brain Diseases

Browse Leaves

Not provided

Browse Branches

Not provided