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NCT Number: NCT06026696

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

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Hemorrhagic Stroke Nervous System Diseases Stroke Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Follow-up

Other

Long term follow-up

Primary outcomes

  1. Incidence of a vascular event

    Time frame: 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 outcomes

  1. Incidence of a vascular event

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: Up to 10 years

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

  14. Obstetrical prognosis

    Time frame: Up to 10 years

    Incidence of pregnancies, complications, delivery methods

  15. Incidence of death

    Time frame: Up to 10 years

    Age and causes of death

  16. Prevalence of vascular risk factors

    Time frame: Up to 10 years

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

  17. Number of associated treatments

    Time frame: Up to 10 years

    Description of the types of treatment used

  18. Number of adverse events

    Time frame: Up to 10 years

    Evaluation of treatment tolerance

  19. Treatment adherence

    Time frame: Up to 10 years

  20. Incidence of headaches

    Time frame: Up to 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Jérôme Lambert, Dr

CONTACT

[email protected]

+33142499742

Peggy Reiner, Dr

CONTACT

[email protected]

+33149956525

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

Cohorte de Maladies Neurovasculaires Prises en Charge à la Phase aiguë et Suivies à Lariboisière

Acronym: NERVAL

Important dates

Study start
2023
Primary completion
2033
Study completion
2038
First posted
Sep 7, 2023
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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