<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/NCT03262246</url>
  </required_header>
  <id_info>
    <org_study_id>ISAAC</org_study_id>
    <nct_id>NCT03262246</nct_id>
  </id_info>
  <brief_title>Cerebral Infarction and White Substance in Angiopathy Cerebral Amyloid</brief_title>
  <official_title>Cerebral Infarction and White Substance in Angiopathy Cerebral Amyloid</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fondation Hôpital Saint-Joseph</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fondation Hôpital Saint-Joseph</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>
      The cerebral amyloïd angiopathy ( AAC) is a disease characterized by deposits of beta-amyloid&#xD;
      peptids in the walls of the arteries of young and average calibre of the brain and the&#xD;
      leptomeninx. The incidence of the AAC increases strongly with the age and represents a major&#xD;
      cause of spontaneous brain haemorrhage to people over 60. The main demonstration is the lobar&#xD;
      brain haemorrhage, the other ones are bleedings under arachnoid cortical and microbleedings&#xD;
      leading to cognitive decline.&#xD;
&#xD;
      Anatomical studies reported the presence of cortical infarcts in patients having amyloïd&#xD;
      deposits suggesting an association between asymptomatic cortical cerebral infarcts and AAC.&#xD;
&#xD;
      However prevalence and meaning of these infarcts in patients having an AAC remain badly known&#xD;
      because of studies on low number of patients and the rarity of radiological analyses of these&#xD;
      infarcts .A better knowledge of these asymptomatic cortical infarcts would allow to dread&#xD;
      better cognitive disorders(confusions) presented by these patients, and to develop preventive&#xD;
      strategies.&#xD;
&#xD;
      Besides, the risk factors of severity of the AAC are little studied.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2, 2016</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>number of patient with cerebral infarction and associated factors in a cohort of cerebral amyloid angiopathy patients</measure>
    <time_frame>1day</time_frame>
  </primary_outcome>
  <enrollment type="Actual">126</enrollment>
  <condition>Amyloid Angiopathy</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>medical report consultation</intervention_name>
    <description>investigators consult medical report concerning patient identified for cerebral amyloid angiopathy</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Investigators select medical report of hospitalized patient between 2011/01/01 and&#xD;
        2015/12/31 in CAEN hospital and Paris St Joseph hospital ; these had an MRI for cerebral&#xD;
        haemorrhage.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age&gt;55&#xD;
&#xD;
          -  hospitalized in CAEN hospital and Paris St Joseph Hospital between 1st january 2011&#xD;
             and 31 december 2015 for cerebral haemorrhage with MRI images diagnosing cerebral&#xD;
             amyloid angiopathy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Insufficient MRI images quality without FLAI sequence, T2 GRE&#xD;
&#xD;
          -  disease with same radiologic and clinical signs that cerebral amyloid angiopathy.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>HODEL Jérome, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>GHPSJ</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Groupe Hospitalier Paris Saint Joseph</name>
      <address>
        <city>Paris</city>
        <state>Ile-de-France</state>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2018</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>February 1, 2019</last_update_submitted>
  <last_update_submitted_qc>February 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 4, 2019</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>Cerebral Infarction</mesh_term>
    <mesh_term>Amyloidosis</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT03262246
org study id: ISAAC
nct id: NCT03262246
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The cerebral amyloïd angiopathy ( AAC) is a disease characterized by deposits of beta-amyloid
      peptids in the walls of the arteries of young and average calibre of the brain and the
      leptomeninx. The incidence of the AAC increases strongly with the age and represents a major
      cause of spontaneous brain haemorrhage to people over 60. The main demonstration is the lobar
      brain haemorrhage, the other ones are bleedings under arachnoid cortical and microbleedings
      leading to cognitive decline.

      Anatomical studies reported the presence of cortical infarcts in patients having amyloïd
      deposits suggesting an association between asymptomatic cortical cerebral infarcts and AAC.

      However prevalence and meaning of these infarcts in patients having an AAC remain badly known
      because of studies on low number of patients and the rarity of radiological analyses of these
      infarcts .A better knowledge of these asymptomatic cortical infarcts would allow to dread
      better cognitive disorders(confusions) presented by these patients, and to develop preventive
      strategies.

      Besides, the risk factors of severity of the AAC are little studied.
observational model: Cohort
time perspective: Retrospective
measure: number of patient with cerebral infarction and associated factors in a cohort of cerebral amyloid angiopathy patients
time frame: 1day
intervention type: Other
intervention name: medical report consultation
description: investigators consult medical report concerning patient identified for cerebral amyloid angiopathy
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: HODEL Jérome, Professor
role: Principal Investigator
affiliation: GHPSJ
facility: 
country: France
responsible party type: Sponsor
mesh term: Cerebral Infarction
mesh term: Amyloidosis
mesh term: Infarction