Cohort of Neurovascular Diseases Treated in the Acute Pha... | NCT06026696

Studies
Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière

NCT06026696

Sponsor

Assistance Publique - Hôpitaux de Paris

Status

Not yet recruiting

Last Update Posted

Sep 7, 2023Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Ischemic Stroke
Hemorrhagic Stroke

Interventions

follow-up

Countries

Not provided

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

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2023Estimated

Primary Completion Date

Sep 2033Estimated

Completion Date

Sep 2038Estimated

First Submitted Date

Aug 21, 2023

First Submission Date that Met QC Criteria

Sep 4, 2023

First Posted Date

Sep 7, 2023Actual

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 4, 2023

Last Update Posted Date

Sep 7, 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

Neurovascular diseases can cause ischaemic or haemorrhagic strokes. While the most common, such as atherosclerosis are widely studied, others are less well known, such as arterial dissections or cerebral angiopathies. What's more, most studies are limited to a few years' follow-up and the longer-term evolution of patients is less well assessed. Patient follow-up data available in routine practice and specific enrollment through the headache emergencies of the Lariboisière neurovascular intensive care unit (USINV) could provide a particularly rich resource.

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

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients treated for acute cerebrovascular pathology cerebrovascular disease			Other: follow-up

Interventions

Name	Type	Description	Arm Group Labels	Other Names
follow-up	Other	Long term follow-up	Patients treated for acute cerebrovascular pathology cerebrovascular disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of a vascular event	Vascular event is defined as : myocardial infarction, ischaemic or haemorrhagic stroke, recurrence of cerebrovascular disease, systemic embolism, congestive heart disease, vascular or non-vascular death during patient follow-up.	Up to 5 years

Secondary Outcomes

Measure	Description	Time Frame
Incidence of a vascular event	Vascular event is defined as : myocardial infarction, ischaemic or haemorrhagic stroke, recurrence of cerebrovascular disease, systemic embolism, congestive heart disease, vascular or non-vascular death during patient follow-up.	Up to 10 years
Modified Rankin score

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients ≥18 years
Patients admitted to the Neurovascular Intensive Care Unit with acute cerebrovascular disease OR Patients managed for acute cerebrovascular pathology with or without stroke by the Lariboisière neurology team.
No opposition from the patient to the research and for patients under guardianship or guardianship or lack of capacity to object (severe impairment of cognitive functions, dementia, etc.), no opposition from the legal representative.

Exclusion Criteria:

Patient refusing to take part in the study or refusal by the legal representative in the case of patients under guardianship or curatorship
Patient suffering from a rare neurovascular disease and being followed at the "Centre de référence des maladies vasculaires rares du cerveau et de l'oeil" (CERVCO)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

100 Years

Standard Ages

AdultOlder Adult

Study Population

Adult patients treated for acute cerebrovascular disease

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Peggy Reiner, Dr	Contact	+33149956525		peggy.reiner@aphp.fr
Jérôme Lambert, Dr	Contact	+33142499742		jerome.lambert@u-paris.fr

Overall Officials

Not provided

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000083242	Ischemic Stroke
D000083302	Hemorrhagic Stroke

Ancestor Terms

ID	Term
D020521	Stroke
D002561	Cerebrovascular Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided