<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/NCT02991157</url>
  </required_header>
  <id_info>
    <org_study_id>12.02</org_study_id>
    <nct_id>NCT02991157</nct_id>
  </id_info>
  <brief_title>Noninvasive Assessment of Cerebral Oxygenation and Cardiac Function in Patients With Neurovascular Diseases</brief_title>
  <official_title>Noninvasive Assessment of Cerebral Oxygenation and Cardiac Function in Patients With Neurovascular Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Mental Health and Neuro Sciences, India</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Mental Health and Neuro Sciences, India</source>
  <brief_summary>
    <textblock>
      This prospective observational study will assess the regional cerebral oxygen saturation and&#xD;
      cardiac output non-invasively in patients with subarachnoid hemorrhage during nimodipine&#xD;
      administration for the prevention/management of cerebral vasospasm.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">November 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine</measure>
    <time_frame>Change from baseline cerebral oxygen saturation at 30 minutes after administration of nimodipine</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in the cardiac output measured using near NICOM technology after administration of nimodipine</measure>
    <time_frame>Change from baseline cardiac output at 30 and 240 minutes after administration of nimodipine</time_frame>
    <description>unit of measurement will be L/min</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine</measure>
    <time_frame>Change from baseline cerebral oxygen saturation at 240 minutes after administration of nimodipine</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">25</enrollment>
  <condition>Subarachnoid Hemorrhage, Aneurysmal</condition>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Nimodipine</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        aneurysmal subarachnoid hemorrhage with cerebral vasospasm&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  aneurysmal subarachnoid hemorrhage&#xD;
&#xD;
          -  potential or actual cerebral vasospasm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-aneurysmal subarachnoid hemorrhage&#xD;
&#xD;
          -  outside the 4-21 day window after ictus&#xD;
&#xD;
          -  peripheral deoxygenation&#xD;
&#xD;
          -  contraindication for nimodipine administration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>NIMHANS</name>
      <address>
        <city>Bengaluru</city>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 9, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>March 23, 2019</last_update_submitted>
  <last_update_submitted_qc>March 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 26, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National Institute of Mental Health and Neuro Sciences, India</investigator_affiliation>
    <investigator_full_name>Sriganesh Kamath</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>cerebral vasospasm</keyword>
  <keyword>nimodipine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Subarachnoid Hemorrhage</mesh_term>
    <mesh_term>Hemorrhage</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nimodipine</mesh_term>
  </intervention_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/NCT02991157
org study id: 12.02
nct id: NCT02991157
lead sponsor: 
This prospective observational study will assess the regional cerebral oxygen saturation and
      cardiac output non-invasively in patients with subarachnoid hemorrhage during nimodipine
      administration for the prevention/management of cerebral vasospasm.
observational model: Cohort
time perspective: Prospective
measure: Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine
time frame: Change from baseline cerebral oxygen saturation at 30 minutes after administration of nimodipine
measure: Change in the cardiac output measured using near NICOM technology after administration of nimodipine
time frame: Change from baseline cardiac output at 30 and 240 minutes after administration of nimodipine
description: unit of measurement will be L/min
measure: Change in the cerebral oxygen saturation percentage measured using near infrared spectroscopy technology after administration of nimodipine
time frame: Change from baseline cerebral oxygen saturation at 240 minutes after administration of nimodipine
intervention type: Drug
intervention name: Nimodipine
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: National Institute of Mental Health and Neuro Sciences, India
investigator full name: Sriganesh Kamath
investigator title: Associate Professor
mesh term: Subarachnoid Hemorrhage
mesh term: Hemorrhage
mesh term: Nimodipine