CoBRA: Clinical and Biological Strokes Collection in Reunion Island

Sponsor

Centre Hospitalier Universitaire de la Réunion (Other)

Overall Status

Recruiting

CT.gov ID

NCT05598138

Collaborator

(none)

2,000

Enrollment

Locations

Arm

29.3

Anticipated Duration (Months)

1000

Patients Per Site

34.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Stroke	Biological: Biological Collection	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

2000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Clinical and Biological Strokes Collection in Reunion Island

Actual Study Start Date :

Jun 22, 2021

Anticipated Primary Completion Date :

Jun 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Intervention A blood sample (10 ml) will be taken for each patient included in the study	Biological: Biological Collection A blood sample (10 ml) will be taken for each patient included in the study.

Arm

Intervention/Treatment

Other: Intervention

A blood sample (10 ml) will be taken for each patient included in the study

Biological: Biological Collection

A blood sample (10 ml) will be taken for each patient included in the study.

Outcome Measures

Primary Outcome Measures

clinico-biological score [at inclusion]
area under the diagnostic score curve identifying ischemic stroke, stroke hemorrhagic or mimics.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de La Réunion	Saint-Denis		Réunion	97400
2	CHU de La Réunion	Saint-Pierre		Réunion	97448

Sponsors and Collaborators

Centre Hospitalier Universitaire de la Réunion

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire de la Réunion

ClinicalTrials.gov Identifier:

NCT05598138

Other Study ID Numbers:

2020/CHU/40

First Posted:

Oct 28, 2022

Last Update Posted:

Oct 28, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Stroke

Study Results

No Results Posted as of Oct 28, 2022