Clinical trial NCT06026696: Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière
Official title: Cohorte de Maladies Neurovasculaires Prises en Charge à la Phase aiguë et Suivies à Lariboisière
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ischemic Stroke
Hemorrhagic Stroke
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-09-07
Enrollment: 5000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients treated for acute cerebrovascular disease

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.


Eligibility criteria: Inclusion Criteria:

1. Adult patients ≥18 years
2. 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.
3. 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:

1. Patient refusing to take part in the study or refusal by the legal representative in the case of patients under guardianship or curatorship
2. 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)

Primary outcomes:
measure: Incidence of a vascular event
timeFrame: Up to 5 years
Secondary outcomes:
measure: Incidence of a vascular event
timeFrame: Up to 10 years
measure: Modified Rankin score
timeFrame: At 3 months
measure: Modified Rankin score
timeFrame: At 1 year
measure: Modified Rankin score
timeFrame: At 2 years
measure: Modified Rankin score
timeFrame: At 3 years
measure: Modified Rankin score
timeFrame: At 4 years
measure: Modified Rankin score
timeFrame: At 5 years
measure: Modified Rankin score
timeFrame: At 6 years
measure: Modified Rankin score
timeFrame: At 7 years
measure: Modified Rankin score
timeFrame: At 8 years
measure: Modified Rankin score
timeFrame: At 9 years
measure: Modified Rankin score
timeFrame: At 10 years
measure: Occurrence of intercurrent pathologies requiring specific treatment
timeFrame: Up to 10 years
measure: Obstetrical prognosis
timeFrame: Up to 10 years
measure: Incidence of death
timeFrame: Up to 10 years
measure: Prevalence of vascular risk factors
timeFrame: Up to 10 years
measure: Number of associated treatments
timeFrame: Up to 10 years
measure: Number of adverse events
timeFrame: Up to 10 years
measure: Treatment adherence
timeFrame: Up to 10 years
measure: Incidence of headaches
timeFrame: Up to 10 years
Other outcomes:
Locations:
Study officials:
References: