Clinical and Biological Strokes Collection in Reunion Island | NCT05598138

Studies
Clinical and Biological Strokes Collection in Reunion Island

NCT05598138

Sponsor

Centre Hospitalier Universitaire de la Réunion

Status

Completed

Last Update Posted

Sep 29, 2023Actual

Enrollment

795Actual

Phase

Not Applicable

Conditions

Stroke

Interventions

Biological Collection

Countries

Reunion

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 2023

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

Jun 22, 2021Actual

Primary Completion Date

Jun 21, 2023Actual

Completion Date

Jun 21, 2023Actual

First Submitted Date

Oct 19, 2022

First Submission Date that Met QC Criteria

Oct 26, 2022

First Posted Date

Oct 28, 2022Actual

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

Sep 28, 2023

Last Update Posted Date

Sep 29, 2023Actual

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

Cross-sectional regional multicenter hospital study of all neurological events (stroke, AIT and mimics) for diagnostic and prognostic purposes. Cost of illness study.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

795Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	A blood sample (10 ml) will be taken for each patient included in the study	Biological: Biological Collection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Biological Collection	Biological	A blood sample (10 ml) will be taken for each patient included in the study.	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
clinico-biological score	area under the diagnostic score curve identifying ischemic stroke, stroke hemorrhagic or mimics.	24 hours after the stroke

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

affiliated to a social security scheme
clinical signs suggestive of stroke : hemiparesis or hemiplegia, unilateral sensory disorder, language disorder, balance disorder, dizziness, loss of total or partial bilateral or monocular vision, sudden neurological deficit

Exclusion Criteria:

current pregnancy
Recent clinical history of head trauma
patients aged < 18 years old
patient under guardianship or curatorship
Person deprived of liberty

Accepts Healthy Volunteers

Yes

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

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de La Réunion		Saint-Denis		97400	Reunion
CHU de La Réunion

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D020521	Stroke

Ancestor Terms

ID	Term
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided