<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/NCT03810729</url>
  </required_header>
  <id_info>
    <org_study_id>20180865-01H</org_study_id>
    <nct_id>NCT03810729</nct_id>
  </id_info>
  <brief_title>Smartphone Assessment Prior Radial Artery Harvesting for CABG</brief_title>
  <acronym>iRADIAL-CABG</acronym>
  <official_title>Utility of a Smartphone Application in Assessing Palmar Circulation Prior to Radial Artery Harvesting for Coronary Artery Bypass Grafting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ottawa Heart Institute Research Corporation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ottawa Heart Institute Research Corporation</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>
      Coronary artery bypass graft (CABG) surgery is a procedure where surgeons use blood vessels&#xD;
      from elsewhere in the body to go around blockages or narrowings in the heart arteries. Before&#xD;
      the surgery, the surgeon needs to choose which vessel will be used for the bypass, including&#xD;
      potentially the radial artery in the wrist. Smartphones have been shown in a previous study&#xD;
      to be a better way to assess the arteries in the hand than the traditional physical&#xD;
      examination, as it is less subjective than simply watching the flushing of the hand. In this&#xD;
      study, the investigators will assess the utility of a smartphone application in determining&#xD;
      whether there is enough blood flow in the hand prior to using the radial artery for CABG&#xD;
      surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Coronary artery bypass graft (CABG) surgery is a procedure where surgeons use blood vessels&#xD;
      from elsewhere in the body to go around blockages or narrowings in the heart arteries. Before&#xD;
      the surgery, the surgeon needs to choose which vessel will be used for the bypass, including&#xD;
      potentially the radial artery in the wrist. Before using this artery, it is important to&#xD;
      ensure that there is enough blood flow to the hand to prevent complications. The best way to&#xD;
      do this involves the use of ultrasound, but this takes a long time and its availability can&#xD;
      be limited. Therefore, the assessment is usually done at the bedside by examining the hand,&#xD;
      which relies on the doctor watching the flushing of the hand during compression and release&#xD;
      of the artery. Currently, smartphones with cameras are able to assess blood flow by passing&#xD;
      light through the skin and observing differences in brightness. This has been shown in a&#xD;
      previous study to be a better way to assess the arteries in the hand than the traditional&#xD;
      examination, as it is less subjective than simply watching the flushing of the hand. In this&#xD;
      study, the investigators will assess the utility of a smartphone application in determining&#xD;
      whether there is enough blood flow in the hand prior to using the radial artery for CABG&#xD;
      surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 15, 2019</start_date>
  <completion_date type="Actual">August 8, 2022</completion_date>
  <primary_completion_date type="Actual">August 8, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with use of the radial artery as a conduit for CABG</measure>
    <time_frame>In-hospital (average of 7 days)</time_frame>
    <description>The primary outcome of this study is the use of the radial artery as a conduit in CABG surgery, which will only occur if the ulnar artery is deemed patent by the corresponding test to which the participant has been randomized to receive (i.e. modified Allen's test or smartphone assessment).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of participants with post-operative hand ischemia</measure>
    <time_frame>In-hospital (average of 7 days)</time_frame>
    <description>Post-operative hand ischemia as determined by clinical assessment by attending physician or by need for a vascular intervention during index hospital admission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with early graft failure</measure>
    <time_frame>In-hospital (average of 7 days)</time_frame>
    <description>Early graft failure as determined by angiography during index hospitalization or by need for rescue percutaneous coronary intervention in the immediate post-operative period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with stroke</measure>
    <time_frame>In-hospital (average of 7 days)</time_frame>
    <description>Stroke as determined by an attending neurologist</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with myocardial infarction</measure>
    <time_frame>In-hospital (average of 7 days)</time_frame>
    <description>Myocardial infarction as defined by the fourth universal definition of myocardial infarction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with cardiovascular death</measure>
    <time_frame>In-hospital (average of 7 days)</time_frame>
    <description>Death from cardiovascular cause as determined by attending physician.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">236</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Modified Allen's Test</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The Modified Allen's Test (MAT) will be performed in a well-lit room on the participant's hand. This technique will involve compression of both the radial and ulnar arteries by the investigator to assess patency of the contralateral artery. The participant will then be asked to clench and open their hand several times. The participant will then be asked to maintain their hand in an open position. The investigator will then release the compression over the ulnar artery and observe for palmar blush. The length of time to achieve maximal palmar blush will be recorded. This technique will then be repeated by maintaining compression over the ulnar artery and releasing of the compression over the radial artery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Smartphone assessment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The smartphone app (Heart Rate, Azumio software) will be used to assess radial and ulnar artery patency. Briefly, the iPhone camera will be placed over the participant's index finger and patency assessed before and immediately following isolated contralateral artery compression for a maximum of two minutes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Smartphone assessment</intervention_name>
    <description>The smartphone app will be performed on participants randomly assigned to receive this test.</description>
    <arm_group_label>Smartphone assessment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Modified Allen's Test</intervention_name>
    <description>The modified Allen's test will be will be performed on participants randomly assigned to receive this test.</description>
    <arm_group_label>Modified Allen's Test</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age greater than or equal to 18 years old&#xD;
&#xD;
          -  Scheduled to undergo coronary artery bypass graft for which the surgeon is considering&#xD;
             the use of a radial artery conduit&#xD;
&#xD;
          -  Able and willing to provide written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hemodynamic instability&#xD;
&#xD;
          -  Need for emergent cardiac surgery&#xD;
&#xD;
          -  Known previous removal of the radial or ulnar arteries&#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>Benjamin Hibbert, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Heart Institute Research Corporation</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Vincent Chan, MD MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ottawa Heart Institute Research Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Ottawa Heart Institute</name>
      <address>
        <city>Ottawa</city>
        <state>Ontario</state>
        <zip>K1Y4W7</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 22, 2019</study_first_posted>
  <last_update_submitted>October 7, 2022</last_update_submitted>
  <last_update_submitted_qc>October 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Smartphone</keyword>
  <keyword>Coronary artery bypass grafting</keyword>
  <keyword>Modified Allen's Test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data from the CAPITAL iRADIAL-CABG study will be made available upon a reasonable request to the principal investigator.</ipd_description>
    <ipd_time_frame>Data will be available following publication of our manuscript and will remain available for 10 years after this time.</ipd_time_frame>
    <ipd_access_criteria>Access will be available upon a reasonable request to the principal investigator.</ipd_access_criteria>
  </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/NCT03810729
org study id: 20180865-01H
nct id: NCT03810729
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Coronary artery bypass graft (CABG) surgery is a procedure where surgeons use blood vessels
      from elsewhere in the body to go around blockages or narrowings in the heart arteries. Before
      the surgery, the surgeon needs to choose which vessel will be used for the bypass, including
      potentially the radial artery in the wrist. Smartphones have been shown in a previous study
      to be a better way to assess the arteries in the hand than the traditional physical
      examination, as it is less subjective than simply watching the flushing of the hand. In this
      study, the investigators will assess the utility of a smartphone application in determining
      whether there is enough blood flow in the hand prior to using the radial artery for CABG
      surgery.
Coronary artery bypass graft (CABG) surgery is a procedure where surgeons use blood vessels
      from elsewhere in the body to go around blockages or narrowings in the heart arteries. Before
      the surgery, the surgeon needs to choose which vessel will be used for the bypass, including
      potentially the radial artery in the wrist. Before using this artery, it is important to
      ensure that there is enough blood flow to the hand to prevent complications. The best way to
      do this involves the use of ultrasound, but this takes a long time and its availability can
      be limited. Therefore, the assessment is usually done at the bedside by examining the hand,
      which relies on the doctor watching the flushing of the hand during compression and release
      of the artery. Currently, smartphones with cameras are able to assess blood flow by passing
      light through the skin and observing differences in brightness. This has been shown in a
      previous study to be a better way to assess the arteries in the hand than the traditional
      examination, as it is less subjective than simply watching the flushing of the hand. In this
      study, the investigators will assess the utility of a smartphone application in determining
      whether there is enough blood flow in the hand prior to using the radial artery for CABG
      surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: Double (Care Provider, Outcomes Assessor)
measure: Number of participants with use of the radial artery as a conduit for CABG
time frame: In-hospital (average of 7 days)
description: The primary outcome of this study is the use of the radial artery as a conduit in CABG surgery, which will only occur if the ulnar artery is deemed patent by the corresponding test to which the participant has been randomized to receive (i.e. modified Allen's test or smartphone assessment).
measure: Number of participants with post-operative hand ischemia
time frame: In-hospital (average of 7 days)
description: Post-operative hand ischemia as determined by clinical assessment by attending physician or by need for a vascular intervention during index hospital admission.
measure: Number of participants with early graft failure
time frame: In-hospital (average of 7 days)
description: Early graft failure as determined by angiography during index hospitalization or by need for rescue percutaneous coronary intervention in the immediate post-operative period
measure: Number of participants with stroke
time frame: In-hospital (average of 7 days)
description: Stroke as determined by an attending neurologist
measure: Number of participants with myocardial infarction
time frame: In-hospital (average of 7 days)
description: Myocardial infarction as defined by the fourth universal definition of myocardial infarction.
measure: Number of participants with cardiovascular death
time frame: In-hospital (average of 7 days)
description: Death from cardiovascular cause as determined by attending physician.
arm group label: Modified Allen's Test
arm group type: Active Comparator
description: The Modified Allen's Test (MAT) will be performed in a well-lit room on the participant's hand. This technique will involve compression of both the radial and ulnar arteries by the investigator to assess patency of the contralateral artery. The participant will then be asked to clench and open their hand several times. The participant will then be asked to maintain their hand in an open position. The investigator will then release the compression over the ulnar artery and observe for palmar blush. The length of time to achieve maximal palmar blush will be recorded. This technique will then be repeated by maintaining compression over the ulnar artery and releasing of the compression over the radial artery.
arm group label: Smartphone assessment
arm group type: Active Comparator
description: The smartphone app (Heart Rate, Azumio software) will be used to assess radial and ulnar artery patency. Briefly, the iPhone camera will be placed over the participant's index finger and patency assessed before and immediately following isolated contralateral artery compression for a maximum of two minutes.
intervention type: Diagnostic Test
intervention name: Smartphone assessment
description: The smartphone app will be performed on participants randomly assigned to receive this test.
arm group label: Smartphone assessment
intervention type: Diagnostic Test
intervention name: Modified Allen's Test
description: The modified Allen's test will be will be performed on participants randomly assigned to receive this test.
arm group label: Modified Allen's Test
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Benjamin Hibbert, MD PhD
role: Principal Investigator
affiliation: Ottawa Heart Institute Research Corporation
last name: Vincent Chan, MD MPH
role: Principal Investigator
affiliation: Ottawa Heart Institute Research Corporation
facility: 
country: Canada
responsible party type: Sponsor
mesh term: Coronary Artery Disease
sharing ipd: Yes
ipd description: The data from the CAPITAL iRADIAL-CABG study will be made available upon a reasonable request to the principal investigator.
ipd time frame: Data will be available following publication of our manuscript and will remain available for 10 years after this time.
ipd access criteria: Access will be available upon a reasonable request to the principal investigator.