<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/NCT03259737</url>
  </required_header>
  <id_info>
    <org_study_id>REK2015/358</org_study_id>
    <nct_id>NCT03259737</nct_id>
  </id_info>
  <brief_title>An Observational Study of Stroke Patients.</brief_title>
  <acronym>SPET-72</acronym>
  <official_title>An Observational Study of Stroke Patients With Focus on Examinations and Therapeutic Improvement the First 72 Hours.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ellen Bøhmer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sykehuset Innlandet HF</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 intention is to study presumed changes in daily practice, probably due to New Guidelines&#xD;
      concerning stroke patients. The impression is more frequent measurements of blood pressure,&#xD;
      serum glucose, troponin and supplementary computer tomography or magnetic resonance imaging.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is in general a focus on misuse of health resources. An increasing amount of guidelines&#xD;
      is produced to reduce the variation in treatment of patients with the same diagnosis. Many&#xD;
      recommendations are weak but seems though to have considerable impact on in hospital care.&#xD;
      The issues to be studied are all grounded on weak clinical evidence. A pilot study confirmed&#xD;
      the suspicion of very frequent measurements of blood pressure, glucose, troponin and frequent&#xD;
      supplementary CT and MRI. The intention is to study these issues in a larger population&#xD;
      including an evaluation of utility of the different examinations and evaluations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">May 1, 2018</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Actual">November 15, 2018</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 supplementary computer tomography and magnetic resonance imaging of the brain.</measure>
    <time_frame>3 months</time_frame>
    <description>Number</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The number of blood sugar measurements</measure>
    <time_frame>72 hours after admission to hospital</time_frame>
    <description>Number</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Troponin measurement,</measure>
    <time_frame>72 hours</time_frame>
    <description>frequency and level of max value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of blood pressure measurement</measure>
    <time_frame>72 hours</time_frame>
    <description>Number</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transfer to tertiary center</measure>
    <time_frame>72 hours</time_frame>
    <description>Number</description>
  </secondary_outcome>
  <enrollment type="Actual">120</enrollment>
  <condition>Quality of Care</condition>
  <condition>Cerebrovascular Disorders</condition>
  <condition>Hyperglycemia</condition>
  <condition>Hypertension</condition>
  <condition>Troponin</condition>
  <eligibility>
    <study_pop>
      <textblock>
        All patients &gt; 18 years, registered with a diagnosis of stroke during 2015 at Innlandet&#xD;
        Hospital Trust Lillehammer.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with a diagnosis of stroke according to ICD 10th revision (code I61 I63 and&#xD;
             I64)&#xD;
&#xD;
          -  Hospitalized between January 1 and December 31, 2015&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous hospitalization with a diagnosis of stroke in 2015.&#xD;
&#xD;
          -  Foreigners and patients from other regions of Norway.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ingebjørg Hartz</last_name>
    <role>Study Director</role>
    <affiliation>Sykehuset Innlandet HF</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Innlandet Hospital Trust Lillehammer</name>
      <address>
        <city>Lillehammer</city>
        <zip>2609</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ellen Bøhmer</name>
      <address>
        <city>Lillehammer</city>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 24, 2017</study_first_posted>
  <last_update_submitted>December 31, 2020</last_update_submitted>
  <last_update_submitted_qc>December 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 5, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sykehuset Innlandet HF</investigator_affiliation>
    <investigator_full_name>Ellen Bøhmer</investigator_full_name>
    <investigator_title>PHD cand med</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cerebrovascular Disorders</mesh_term>
    <mesh_term>Hyperglycemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03259737
org study id: REK2015/358
nct id: NCT03259737
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The intention is to study presumed changes in daily practice, probably due to New Guidelines
      concerning stroke patients. The impression is more frequent measurements of blood pressure,
      serum glucose, troponin and supplementary computer tomography or magnetic resonance imaging.
There is in general a focus on misuse of health resources. An increasing amount of guidelines
      is produced to reduce the variation in treatment of patients with the same diagnosis. Many
      recommendations are weak but seems though to have considerable impact on in hospital care.
      The issues to be studied are all grounded on weak clinical evidence. A pilot study confirmed
      the suspicion of very frequent measurements of blood pressure, glucose, troponin and frequent
      supplementary CT and MRI. The intention is to study these issues in a larger population
      including an evaluation of utility of the different examinations and evaluations.
observational model: Cohort
time perspective: Retrospective
measure: Number of supplementary computer tomography and magnetic resonance imaging of the brain.
time frame: 3 months
description: Number
measure: The number of blood sugar measurements
time frame: 72 hours after admission to hospital
description: Number
measure: Troponin measurement,
time frame: 72 hours
description: frequency and level of max value
measure: Number of blood pressure measurement
time frame: 72 hours
description: Number
measure: Transfer to tertiary center
time frame: 72 hours
description: Number
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ingebjørg Hartz
role: Study Director
affiliation: Sykehuset Innlandet HF
facility: 
facility: 
country: Norway
responsible party type: Sponsor-Investigator
investigator affiliation: Sykehuset Innlandet HF
investigator full name: Ellen Bøhmer
investigator title: PHD cand med
mesh term: Cerebrovascular Disorders
mesh term: Hyperglycemia
sharing ipd: No