<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/NCT03303404</url>
  </required_header>
  <id_info>
    <org_study_id>2017-07-0043</org_study_id>
    <nct_id>NCT03303404</nct_id>
  </id_info>
  <brief_title>24-hour Blood Pressure Measurements and Ischemic Conditioning</brief_title>
  <official_title>24-hour Blood Pressure Measurements and Ischemic Conditioning</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas at Austin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas at Austin</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine if 24-hr ambulatory blood pressure monitoring effects endothelial function, we&#xD;
      will measure flow-mediated dilation before and after the blood pressure monitoring (ischemia&#xD;
      conditioning).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reestablishing blood flow (reperfusion) to organs that had their blood supply restricted&#xD;
      (ischemia) can cause damage to the vasculature via injury and tissue death resulting in&#xD;
      endothelial dysfunction. This ischemia-reperfusion (blood flow occlusion and resupply)&#xD;
      triggered injury can be reduced or prevented by preceding brief periods of ischemia called&#xD;
      preconditioning. Properly-performed preconditioning can exert a powerful protection against a&#xD;
      subsequent sustained period of ischemia in a variety of organs in the body including the&#xD;
      heart, kidney, and skeletal muscle. Preconditioning protocol involves repeated brief&#xD;
      inflation and deflation of a blood pressure cuff. In many of human cardiovascular research&#xD;
      studies, it is common to measure endothelial function and ambulatory (24-hour) blood&#xD;
      pressure. The ambulatory blood pressure device takes repeated blood pressure readings every&#xD;
      15-30 minutes during the daytime and 30-60 minutes at night. It is possible that repeated&#xD;
      bouts of inflation/deflation of the blood pressure cuff could induce preconditioning effects&#xD;
      and influence endothelial function. Therefore, in the proposed study we aim to address this&#xD;
      hypothesis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 12, 2017</start_date>
  <completion_date type="Actual">September 20, 2018</completion_date>
  <primary_completion_date type="Actual">September 20, 2018</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change From Baseline in Flow Mediated Dilation After 24 Hour Ischemic Conditioning With Blood Pressure Cuff</measure>
    <time_frame>Baseline, Post 24 hour conditioning</time_frame>
    <description>Flow-mediated dilatation (FMD) is a common and non-invasive method to assess vascular endothelial function by measuring the Brachial artery's responsiveness (diameter percent increase) following a brief period of occlusion.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Blood Pressure</condition>
  <arm_group>
    <arm_group_label>Ambulatory (24-hour) Blood Pressure</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ambulatory (24-hour) Blood Pressure</intervention_name>
    <description>Unlike casual blood pressure measurements, 24-hour ambulatory blood pressure monitoring provides an insight into blood pressure changes in everyday life and an estimate of the overall blood pressure load exerted on the cardiovascular system over 24 hours. Blood pressure recordings over a 24-hour period of normal daily activity will be made using a noninvasive ambulatory monitor (Spacelabs, Redlands, WA). The ambulatory system will be calibrated against a mercury sphygmomanometer, and the cuff will be programmed to inflate automatically every 15 min from 6 AM to 11 PM and every 20 min between 11 PM and 6 AM. For each individual subject, the nighttime period will be defined as the time when the subject goes to bed at night until rising in the morning. Daytime will be defined as the remainder of the 24-hour period. Daytime and nighttime states will be monitored by an Actiwatch (Mini-MItter, Bend, OR), a watch-like device placed on the wrist that measures gross motor activity.</description>
    <arm_group_label>Ambulatory (24-hour) Blood Pressure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Adults aged between 30 to 60 years old.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Exclusion from the study may be due to: i) pregnancy (by asking the subjects when the last&#xD;
        time she had menstruation; we do have simple testing kits available if a subject is unsure&#xD;
        about her status); ii) a recent illness, recent surgery, or any medical intervention in the&#xD;
        48 hours before any of the study days; iii) personal history of diabetes (fasting blood&#xD;
        glucose &gt; 126 mg/dL), heart disease, or other cardiovascular problems.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Dr. Hirofumi Tanaka</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78713</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>October 2, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <results_first_submitted>August 27, 2019</results_first_submitted>
  <results_first_submitted_qc>December 21, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">December 22, 2020</results_first_posted>
  <last_update_submitted>December 21, 2020</last_update_submitted>
  <last_update_submitted_qc>December 21, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 12, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/04/NCT03303404/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Ambulatory (24-hour) Blood Pressure</title>
          <description>Ambulatory (24-hour) Blood Pressure: Unlike casual blood pressure measurements, 24-hour ambulatory blood pressure monitoring provides an insight into blood pressure changes in everyday life and an estimate of the overall blood pressure load exerted on the cardiovascular system over 24 hours. Blood pressure recordings over a 24-hour period of normal daily activity will be made using a noninvasive ambulatory monitor (Spacelabs, Redlands, WA). The ambulatory system will be calibrated against a mercury sphygmomanometer, and the cuff will be programmed to inflate automatically every 15 min from 6 AM to 11 PM and every 20 min between 11 PM and 6 AM. For each individual subject, the nighttime period will be defined as the time when the subject goes to bed at night until rising in the morning. Daytime will be defined as the remainder of the 24-hour period.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Ambulatory (24-hour) Blood Pressure</title>
          <description>Ambulatory (24-hour) Blood Pressure: Unlike casual blood pressure measurements, 24-hour ambulatory blood pressure monitoring provides an insight into blood pressure changes in everyday life and an estimate of the overall blood pressure load exerted on the cardiovascular system over 24 hours. Blood pressure recordings over a 24-hour period of normal daily activity will be made using a noninvasive ambulatory monitor (Spacelabs, Redlands, WA). The ambulatory system will be calibrated against a mercury sphygmomanometer, and the cuff will be programmed to inflate automatically every 15 min from 6 AM to 11 PM and every 20 min between 11 PM and 6 AM. For each individual subject, the nighttime period will be defined as the time when the subject goes to bed at night until rising in the morning. Daytime will be defined as the remainder of the 24-hour period.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="22"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41" spread="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change From Baseline in Flow Mediated Dilation After 24 Hour Ischemic Conditioning With Blood Pressure Cuff</title>
        <description>Flow-mediated dilatation (FMD) is a common and non-invasive method to assess vascular endothelial function by measuring the Brachial artery's responsiveness (diameter percent increase) following a brief period of occlusion.</description>
        <time_frame>Baseline, Post 24 hour conditioning</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>This is a single arm acute intervention study.</description>
          </group>
        </group_list>
        <measure>
          <title>Change From Baseline in Flow Mediated Dilation After 24 Hour Ischemic Conditioning With Blood Pressure Cuff</title>
          <description>Flow-mediated dilatation (FMD) is a common and non-invasive method to assess vascular endothelial function by measuring the Brachial artery's responsiveness (diameter percent increase) following a brief period of occlusion.</description>
          <units>percentage of baseline</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.6" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>6 months</time_frame>
      <desc>The procedures to be used in this investigation posed very minimal risk to our subjects.</desc>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>This is a single arm study did not involve grouping.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Brandon Fico</name_or_title>
      <organization>University of Texas at Austin</organization>
      <phone>512-471-8594</phone>
      <email>bfico@utexas.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT03303404
org study id: 2017-07-0043
nct id: NCT03303404
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
To determine if 24-hr ambulatory blood pressure monitoring effects endothelial function, we
      will measure flow-mediated dilation before and after the blood pressure monitoring (ischemia
      conditioning).
Reestablishing blood flow (reperfusion) to organs that had their blood supply restricted
      (ischemia) can cause damage to the vasculature via injury and tissue death resulting in
      endothelial dysfunction. This ischemia-reperfusion (blood flow occlusion and resupply)
      triggered injury can be reduced or prevented by preceding brief periods of ischemia called
      preconditioning. Properly-performed preconditioning can exert a powerful protection against a
      subsequent sustained period of ischemia in a variety of organs in the body including the
      heart, kidney, and skeletal muscle. Preconditioning protocol involves repeated brief
      inflation and deflation of a blood pressure cuff. In many of human cardiovascular research
      studies, it is common to measure endothelial function and ambulatory (24-hour) blood
      pressure. The ambulatory blood pressure device takes repeated blood pressure readings every
      15-30 minutes during the daytime and 30-60 minutes at night. It is possible that repeated
      bouts of inflation/deflation of the blood pressure cuff could induce preconditioning effects
      and influence endothelial function. Therefore, in the proposed study we aim to address this
      hypothesis.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Change From Baseline in Flow Mediated Dilation After 24 Hour Ischemic Conditioning With Blood Pressure Cuff
time frame: Baseline, Post 24 hour conditioning
description: Flow-mediated dilatation (FMD) is a common and non-invasive method to assess vascular endothelial function by measuring the Brachial artery's responsiveness (diameter percent increase) following a brief period of occlusion.
arm group label: Ambulatory (24-hour) Blood Pressure
arm group type: Experimental
intervention type: Device
intervention name: Ambulatory (24-hour) Blood Pressure
description: Unlike casual blood pressure measurements, 24-hour ambulatory blood pressure monitoring provides an insight into blood pressure changes in everyday life and an estimate of the overall blood pressure load exerted on the cardiovascular system over 24 hours. Blood pressure recordings over a 24-hour period of normal daily activity will be made using a noninvasive ambulatory monitor (Spacelabs, Redlands, WA). The ambulatory system will be calibrated against a mercury sphygmomanometer, and the cuff will be programmed to inflate automatically every 15 min from 6 AM to 11 PM and every 20 min between 11 PM and 6 AM. For each individual subject, the nighttime period will be defined as the time when the subject goes to bed at night until rising in the morning. Daytime will be defined as the remainder of the 24-hour period. Daytime and nighttime states will be monitored by an Actiwatch (Mini-MItter, Bend, OR), a watch-like device placed on the wrist that measures gross motor activity.
arm group label: Ambulatory (24-hour) Blood Pressure
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
sharing ipd: Undecided
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 