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/NCT06033378</url>
    </required_header>
    <id_info>
      <org_study_id>2022-06754-01</org_study_id>
      <nct_id>NCT06033378</nct_id>
    </id_info>
    <brief_title>Blood Pressure Treatment in ICU Patients With Subarachniodal Haemorrhage.</brief_title>
    <acronym>BFBP</acronym>
    <official_title>Blood Pressure Treatment in ICU Patients With Subarachniodal Haemorrhage. -Can Blood Pressure be Used as a Surrogate Marker for Blood Flow</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Umeå University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Region Västerbotten</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Umeå University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        An MRI study to examine the relationship between blood pressure and cerebral blood flow in&#xD;
        patients with subarachnoidal hemorrhage and suspect or verified vasospasm.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Subarachnoidal hemorrhage (SAH) is a type of stroke with high mortality rates and often&#xD;
        requires care at the intensive care unit. Cerebral blood flow (CBF) needs to be ensured so&#xD;
        that the brain receives optimal nourishment, and this is largely controlled by regulating&#xD;
        blood pressure (BP) using medications that affect the heart and blood vessels. Approximately&#xD;
        3-7 days after SAH onset, vasospasm (SAH-V) can occur. Treatment usually includes maintaining&#xD;
        blood pressure (BP) above a certain threshold to achieve adequate cerebral blood flow (CBF).&#xD;
        An important component of raising BP is increasing vascular resistance using vasoconstrictive&#xD;
        medications, which paradoxically can decrease CBF.&#xD;
  &#xD;
        Our objective is to investigate the correlation between BP changes and their impact on CBF in&#xD;
        patients with suspect or verified SAH-V using MRO.&#xD;
  &#xD;
        To achieve our purpose, we plan to examine the relationship between BP and CBF in patients&#xD;
        with SAH-V who require neuro-intensive care. For measuring CBF, we will use MRI with two&#xD;
        different MRI techniques: phase-contrast MRI and arterial spin labeling.&#xD;
  &#xD;
        Flow measurement with MRI:&#xD;
  &#xD;
          1. Baseline images will be acquired at baseline blood pressure.&#xD;
  &#xD;
          2. Mean arterial pressure (MAP) will be increased using norepinephrine. New images will be&#xD;
             acquired when MAP is increased by approximately 20-30% from the baseline.&#xD;
  &#xD;
        All BP levels will be maintained within clinically acceptable ranges. All data will be&#xD;
        recorded in the patient's medical record, and MRI images will be processed at a later stage.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">September 1, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>N/A</allocation>
      <intervention_model>Single Group Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Cerebral blood flow</measure>
      <time_frame>1 hour</time_frame>
      <description>mL/min as measured by MRI</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Blood Pressure</condition>
    <condition>Subarachnoid Hemorrhage</condition>
    <condition>Aneurysm Cerebral</condition>
    <arm_group>
      <arm_group_label>Cerebral blood flow</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Change in cerebral blood flow with increased systemic blood pressure</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Blood pressure elevation</intervention_name>
      <description>Increasing systemic blood pressure for measurement of cerebral blood flow changes</description>
      <arm_group_label>Cerebral blood flow</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Coiled or clipped aneurysm Suspected or confirmed vasospasm&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          BMI &gt;30 Pregnancy Pacemaker or other MRI contraindications Severe congestive heart failure&#xD;
          (NYHA III-IV) or cardiac arrhythmia. Severe respiratory failure or FiO2 &gt;0.6 Severe kidney&#xD;
          failure&#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>Laleh Zarrinkoob</last_name>
      <role>Principal Investigator</role>
      <affiliation>Region Västerbotten</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Laleh Zarrinkoob, MD, PhD</last_name>
      <phone>+46707567067</phone>
      <email>laleh.zarrinkoob@umu.se</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 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 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>magnetic resonance imaging</keyword>
    <keyword>norepinephrine</keyword>
    <keyword>blood flow</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Subarachnoid Hemorrhage</mesh_term>
      <mesh_term>Aneurysm</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06033378
  org study id: 2022-06754-01
  nct id: NCT06033378
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  An MRI study to examine the relationship between blood pressure and cerebral blood flow in
        patients with subarachnoidal hemorrhage and suspect or verified vasospasm.
  Subarachnoidal hemorrhage (SAH) is a type of stroke with high mortality rates and often
        requires care at the intensive care unit. Cerebral blood flow (CBF) needs to be ensured so
        that the brain receives optimal nourishment, and this is largely controlled by regulating
        blood pressure (BP) using medications that affect the heart and blood vessels. Approximately
        3-7 days after SAH onset, vasospasm (SAH-V) can occur. Treatment usually includes maintaining
        blood pressure (BP) above a certain threshold to achieve adequate cerebral blood flow (CBF).
        An important component of raising BP is increasing vascular resistance using vasoconstrictive
        medications, which paradoxically can decrease CBF.
  
        Our objective is to investigate the correlation between BP changes and their impact on CBF in
        patients with suspect or verified SAH-V using MRO.
  
        To achieve our purpose, we plan to examine the relationship between BP and CBF in patients
        with SAH-V who require neuro-intensive care. For measuring CBF, we will use MRI with two
        different MRI techniques: phase-contrast MRI and arterial spin labeling.
  
        Flow measurement with MRI:
  
          1. Baseline images will be acquired at baseline blood pressure.
  
          2. Mean arterial pressure (MAP) will be increased using norepinephrine. New images will be
             acquired when MAP is increased by approximately 20-30% from the baseline.
  
        All BP levels will be maintained within clinically acceptable ranges. All data will be
        recorded in the patient's medical record, and MRI images will be processed at a later stage.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Cerebral blood flow
  time frame: 1 hour
  description: mL/min as measured by MRI
  arm group label: Cerebral blood flow
  arm group type: Experimental
  description: Change in cerebral blood flow with increased systemic blood pressure
  intervention type: Other
  intervention name: Blood pressure elevation
  description: Increasing systemic blood pressure for measurement of cerebral blood flow changes
  arm group label: Cerebral blood flow
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Laleh Zarrinkoob
  role: Principal Investigator
  affiliation: Region Västerbotten
  last name: Laleh Zarrinkoob, MD, PhD
  phone: +46707567067
  email: laleh.zarrinkoob@umu.se
  responsible party type: Sponsor
  mesh term: Subarachnoid Hemorrhage
  mesh term: Aneurysm
  mesh term: Hemorrhage
  sharing ipd: No