NCT06026696

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,000

participants targeted

Target at P75+ for all trials

Timeline
149mo left

Started Sep 2023

Longer than P75 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress19%
Sep 2023Sep 2038

First Submitted

Initial submission to the registry

August 21, 2023

Completed
11 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 7, 2023

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2033

Expected
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2038

Last Updated

September 7, 2023

Status Verified

July 1, 2023

Enrollment Period

10 years

First QC Date

August 21, 2023

Last Update Submit

September 4, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 (20)

  • Incidence of a vascular event

    Up to 10 years

  • Modified Rankin score

    At 3 months

  • Modified Rankin score

    At 1 year

  • Modified Rankin score

    At 2 years

  • Modified Rankin score

    At 3 years

  • +15 more secondary outcomes

Study Arms (1)

Patients treated for acute cerebrovascular pathology cerebrovascular disease

Other: follow-up

Interventions

Long term follow-up

Patients treated for acute cerebrovascular pathology cerebrovascular disease

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients treated for acute cerebrovascular disease

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Ischemic StrokeHemorrhagic Stroke

Condition Hierarchy (Ancestors)

StrokeCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Peggy Reiner, Dr

CONTACT

Jérôme Lambert, Dr

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 21, 2023

First Posted

September 7, 2023

Study Start

September 1, 2023

Primary Completion (Estimated)

September 1, 2033

Study Completion (Estimated)

September 1, 2038

Last Updated

September 7, 2023

Record last verified: 2023-07