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

Sponsor
Assistance Publique - Hôpitaux de Paris (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06026696
Collaborator
(none)
5,000
180

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: follow-up

Study Design

Study Type:
Observational
Anticipated Enrollment :
5000 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
Cohorte de Maladies Neurovasculaires Prises en Charge à la Phase aiguë et Suivies à Lariboisière
Anticipated Study Start Date :
Sep 1, 2023
Anticipated Primary Completion Date :
Sep 1, 2033
Anticipated Study Completion Date :
Sep 1, 2038

Arms and Interventions

Arm Intervention/Treatment
Patients treated for acute cerebrovascular pathology cerebrovascular disease

Other: follow-up
Long term follow-up

Outcome Measures

Primary Outcome Measures

  1. Incidence of a vascular event [Up to 5 years]

    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.

Secondary Outcome Measures

  1. Incidence of a vascular event [Up to 10 years]

    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.

  2. Modified Rankin score [At 3 months]

    The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.

  3. Modified Rankin score [At 1 year]

    The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.

  4. Modified Rankin score [At 2 years]

    The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.

  5. Modified Rankin score [At 3 years]

    The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.

  6. Modified Rankin score [At 4 years]

    The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.

  7. Modified Rankin score [At 5 years]

    The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.

  8. Modified Rankin score [At 6 years]

    The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.

  9. Modified Rankin score [At 7 years]

    The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.

  10. Modified Rankin score [At 8 years]

    The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.

  11. Modified Rankin score [At 9 years]

    The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.

  12. Modified Rankin score [At 10 years]

    The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.

  13. Occurrence of intercurrent pathologies requiring specific treatment [Up to 10 years]

    Pathologies are defined as : anxiety-depressive disorder, dementia, comititude, neoplasia, venous thromboembolism, haemorrhage, systemic disease, respiratory insufficiency

  14. Obstetrical prognosis [Up to 10 years]

    Incidence of pregnancies, complications, delivery methods

  15. Incidence of death [Up to 10 years]

    Age and causes of death

  16. Prevalence of vascular risk factors [Up to 10 years]

    Medical history, LDL (Low Density Lipoprotein), Tobacco, Arterial pressure, HbA1C (glycated hemoglobin)

  17. Number of associated treatments [Up to 10 years]

    Description of the types of treatment used

  18. Number of adverse events [Up to 10 years]

    Evaluation of treatment tolerance

  19. Treatment adherence [Up to 10 years]

  20. Incidence of headaches [Up to 10 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assistance Publique - Hôpitaux de Paris

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier:
NCT06026696
Other Study ID Numbers:
  • APHP221076
First Posted:
Sep 7, 2023
Last Update Posted:
Sep 7, 2023
Last Verified:
Jul 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 7, 2023