xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06026696</url>
    </required_header>
    <id_info>
      <org_study_id>APHP221076</org_study_id>
      <nct_id>NCT06026696</nct_id>
    </id_info>
    <brief_title>Cohort of Neurovascular Diseases Treated in the Acute Phase and Followed at Lariboisière</brief_title>
    <acronym>NERVAL</acronym>
    <official_title>Cohorte de Maladies Neurovasculaires Prises en Charge à la Phase aiguë et Suivies à Lariboisière</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Neurovascular diseases can cause ischaemic or haemorrhagic strokes. While the most common,&#xD;
        such as atherosclerosis are widely studied, others are less well known, such as arterial&#xD;
        dissections or cerebral angiopathies. What's more, most studies are limited to a few years'&#xD;
        follow-up and the longer-term evolution of patients is less well assessed. Patient follow-up&#xD;
        data available in routine practice and specific enrollment through the headache emergencies&#xD;
        of the Lariboisière neurovascular intensive care unit (USINV) could provide a particularly&#xD;
        rich resource.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">September 2038</completion_date>
    <primary_completion_date type="Anticipated">September 2033</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Incidence of a vascular event</measure>
      <time_frame>Up to 5 years</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of a vascular event</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Rankin score</measure>
      <time_frame>At 3 months</time_frame>
      <description>The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Rankin score</measure>
      <time_frame>At 1 year</time_frame>
      <description>The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Rankin score</measure>
      <time_frame>At 2 years</time_frame>
      <description>The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Rankin score</measure>
      <time_frame>At 3 years</time_frame>
      <description>The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Rankin score</measure>
      <time_frame>At 4 years</time_frame>
      <description>The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Rankin score</measure>
      <time_frame>At 5 years</time_frame>
      <description>The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Rankin score</measure>
      <time_frame>At 6 years</time_frame>
      <description>The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Rankin score</measure>
      <time_frame>At 7 years</time_frame>
      <description>The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Rankin score</measure>
      <time_frame>At 8 years</time_frame>
      <description>The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Rankin score</measure>
      <time_frame>At 9 years</time_frame>
      <description>The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Modified Rankin score</measure>
      <time_frame>At 10 years</time_frame>
      <description>The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of intercurrent pathologies requiring specific treatment</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>Pathologies are defined as : anxiety-depressive disorder, dementia, comititude, neoplasia, venous thromboembolism, haemorrhage, systemic disease, respiratory insufficiency</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Obstetrical prognosis</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>Incidence of pregnancies, complications, delivery methods</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of death</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>Age and causes of death</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prevalence of vascular risk factors</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>Medical history, LDL (Low Density Lipoprotein), Tobacco, Arterial pressure, HbA1C (glycated hemoglobin)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of associated treatments</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>Description of the types of treatment used</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of adverse events</measure>
      <time_frame>Up to 10 years</time_frame>
      <description>Evaluation of treatment tolerance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Treatment adherence</measure>
      <time_frame>Up to 10 years</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of headaches</measure>
      <time_frame>Up to 10 years</time_frame>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">5000</enrollment>
    <condition>Ischemic Stroke</condition>
    <condition>Hemorrhagic Stroke</condition>
    <arm_group>
      <arm_group_label>Patients treated for acute cerebrovascular pathology cerebrovascular disease</arm_group_label>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>follow-up</intervention_name>
      <description>Long term follow-up</description>
      <arm_group_label>Patients treated for acute cerebrovascular pathology cerebrovascular disease</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Adult patients treated for acute cerebrovascular disease&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adult patients ≥18 years&#xD;
  &#xD;
            2. Patients admitted to the Neurovascular Intensive Care Unit with acute cerebrovascular&#xD;
               disease OR Patients managed for acute cerebrovascular pathology with or without stroke&#xD;
               by the Lariboisière neurology team.&#xD;
  &#xD;
            3. No opposition from the patient to the research and for patients under guardianship or&#xD;
               guardianship or lack of capacity to object (severe impairment of cognitive functions,&#xD;
               dementia, etc.), no opposition from the legal representative.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patient refusing to take part in the study or refusal by the legal representative in&#xD;
               the case of patients under guardianship or curatorship&#xD;
  &#xD;
            2. Patient suffering from a rare neurovascular disease and being followed at the &quot;Centre&#xD;
               de référence des maladies vasculaires rares du cerveau et de l'oeil&quot; (CERVCO)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Peggy Reiner, Dr</last_name>
      <phone>+33149956525</phone>
      <email>peggy.reiner@aphp.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jérôme Lambert, Dr</last_name>
      <phone>+33142499742</phone>
      <email>jerome.lambert@u-paris.fr</email>
    </overall_contact_backup>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stroke</mesh_term>
      <mesh_term>Ischemic Stroke</mesh_term>
      <mesh_term>Hemorrhagic Stroke</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06026696
  org study id: APHP221076
  nct id: NCT06026696
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  observational model: Cohort
  time perspective: Cross-Sectional
  measure: Incidence of a vascular event
  time frame: Up to 5 years
  description: 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.
  measure: Incidence of a vascular event
  time frame: Up to 10 years
  description: 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.
  measure: Modified Rankin score
  time frame: At 3 months
  description: The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
  measure: Modified Rankin score
  time frame: At 1 year
  description: The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
  measure: Modified Rankin score
  time frame: At 2 years
  description: The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
  measure: Modified Rankin score
  time frame: At 3 years
  description: The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
  measure: Modified Rankin score
  time frame: At 4 years
  description: The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
  measure: Modified Rankin score
  time frame: At 5 years
  description: The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
  measure: Modified Rankin score
  time frame: At 6 years
  description: The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
  measure: Modified Rankin score
  time frame: At 7 years
  description: The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
  measure: Modified Rankin score
  time frame: At 8 years
  description: The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
  measure: Modified Rankin score
  time frame: At 9 years
  description: The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
  measure: Modified Rankin score
  time frame: At 10 years
  description: The modified Rankin score is a 6 point disability scale varying between 0 to 5. The higher the score, the greater the disability.
  measure: Occurrence of intercurrent pathologies requiring specific treatment
  time frame: Up to 10 years
  description: Pathologies are defined as : anxiety-depressive disorder, dementia, comititude, neoplasia, venous thromboembolism, haemorrhage, systemic disease, respiratory insufficiency
  measure: Obstetrical prognosis
  time frame: Up to 10 years
  description: Incidence of pregnancies, complications, delivery methods
  measure: Incidence of death
  time frame: Up to 10 years
  description: Age and causes of death
  measure: Prevalence of vascular risk factors
  time frame: Up to 10 years
  description: Medical history, LDL (Low Density Lipoprotein), Tobacco, Arterial pressure, HbA1C (glycated hemoglobin)
  measure: Number of associated treatments
  time frame: Up to 10 years
  description: Description of the types of treatment used
  measure: Number of adverse events
  time frame: Up to 10 years
  description: Evaluation of treatment tolerance
  measure: Treatment adherence
  time frame: Up to 10 years
  measure: Incidence of headaches
  time frame: Up to 10 years
  arm group label: Patients treated for acute cerebrovascular pathology cerebrovascular disease
  intervention type: Other
  intervention name: follow-up
  description: Long term follow-up
  arm group label: Patients treated for acute cerebrovascular pathology cerebrovascular disease
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Peggy Reiner, Dr
  phone: +33149956525
  email: peggy.reiner@aphp.fr
  last name: Jérôme Lambert, Dr
  phone: +33142499742
  email: jerome.lambert@u-paris.fr
  responsible party type: Sponsor
  mesh term: Stroke
  mesh term: Ischemic Stroke
  mesh term: Hemorrhagic Stroke
  sharing ipd: Undecided