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/NCT06000540</url>
    </required_header>
    <id_info>
      <org_study_id>15803</org_study_id>
      <nct_id>NCT06000540</nct_id>
    </id_info>
    <brief_title>Needle Free Assessment of Myocardial Oxygenation in Healthy Subjects</brief_title>
    <acronym>NIMO-Healthy</acronym>
    <official_title>A Prospective Pilot Study to Evaluate the Safety, Tolerability and Efficacy of Utilizing Precise Computer Controlled Gas Challenge in Healthy Subjects for Identification of Coronary Artery Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rohan Dharmakumar</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Indiana University</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>Yes</is_fda_regulated_device>
      <is_unapproved_device>Yes</is_unapproved_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a prospective pilot study to evaluate the safety, tolerability and efficacy of&#xD;
        utilizing precise computer controlled gas challenge in healthy subjects for identification of&#xD;
        coronary artery disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This study will establish the safe and tolerable level of high PC02 and low P02 for future&#xD;
        studies as potential stressors for coronary artery disease assessment.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 15, 2023</start_date>
    <completion_date type="Anticipated">October 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 15, 2024</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>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Physiological Parameters Monitoring</measure>
      <time_frame>3 hours</time_frame>
      <description>Saturation of peripheral oxygen as percentage&#xD;
  Heart rate as beats per minute&#xD;
  Noninvasive blood pressure as mmHg&#xD;
  Partial pressure of oxygen as mmHg&#xD;
  Partial pressure of carbon dioxide as mmHg</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Assessment of Symptom Severity and Incidence</measure>
      <time_frame>3 hours</time_frame>
      <description>Chest pain&#xD;
  Headache&#xD;
  Dizziness&#xD;
  Confusion&#xD;
  Fatigue&#xD;
  Upset stomach&#xD;
  Nausea&#xD;
  Vomiting</description>
    </primary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Coronary Artery Disease</condition>
    <arm_group>
      <arm_group_label>Healthy Subjects</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>RespirAct</intervention_name>
      <description>RespirAct device-based computer-controlled gas delivery at different concentrations as per protocol</description>
      <arm_group_label>Healthy Subjects</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adults ≥ 45 years of age&#xD;
  &#xD;
            2. No known cardiac disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Low blood pressure (systolic blood pressure &lt; 100 mmHg)&#xD;
  &#xD;
            2. Inability to voluntarily increase their breathing rate if prompted to do so&#xD;
  &#xD;
            3. Persons with the inability to lie supine for 30-40 minutes&#xD;
  &#xD;
            4. Persons who are pregnant, nursing, or implanted with intrauterine devices (IUD's)&#xD;
  &#xD;
            5. Persons with significant neurological, pulmonary, renal or hepatic disease&#xD;
  &#xD;
            6. Persons who have an abnormal cardiac rhythm or resting heart rate &gt;100/min&#xD;
  &#xD;
            7. Inability or unwillingness to provide informed consent&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>45 Years</minimum_age>
      <maximum_age>75 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Chandana Saha, PhD</last_name>
      <phone>317 274 0975</phone>
      <email>csaha@iu.edu</email>
    </overall_contact>
    <location>
      <facility>
        <name>IU Health Methodist Hospital</name>
        <address>
          <city>Indianapolis</city>
          <state>Indiana</state>
          <zip>46202</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Rohan Dharmakumar, PhD</last_name>
        <phone>317-274-0992</phone>
        <email>rdkumar@iu.edu</email>
      </contact>
      <investigator>
        <last_name>Keyur Vora, MD MS</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <results_reference>
      <citation>Yang HJ, Dey D, Sykes J, Butler J, Biernaski H, Kovacs M, Bi X, Sharif B, Cokic I, Tang R, Slomka P, Prato FS, Dharmakumar R. Heart Rate-Independent 3D Myocardial Blood Oxygen Level-Dependent MRI at 3.0 T with Simultaneous 13N-Ammonia PET Validation. Radiology. 2020 Apr;295(1):82-93. doi: 10.1148/radiol.2020191456. Epub 2020 Feb 25.</citation>
      <PMID>32096705</PMID>
    </results_reference>
    <results_reference>
      <citation>Poublanc J, Sobczyk O, Shafi R, Sayin ES, Schulman J, Duffin J, Uludag K, Wood JC, Vu C, Dharmakumar R, Fisher JA, Mikulis DJ. Perfusion MRI using endogenous deoxyhemoglobin as a contrast agent: Preliminary data. Magn Reson Med. 2021 Dec;86(6):3012-3021. doi: 10.1002/mrm.28974. Epub 2021 Oct 22.</citation>
      <PMID>34687064</PMID>
    </results_reference>
    <results_reference>
      <citation>Spano VR, Mandell DM, Poublanc J, Sam K, Battisti-Charbonney A, Pucci O, Han JS, Crawley AP, Fisher JA, Mikulis DJ. CO2 blood oxygen level-dependent MR mapping of cerebrovascular reserve in a clinical population: safety, tolerability, and technical feasibility. Radiology. 2013 Feb;266(2):592-8. doi: 10.1148/radiol.12112795. Epub 2012 Nov 30.</citation>
      <PMID>23204541</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 3, 2023</study_first_submitted>
    <study_first_submitted_qc>August 17, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 31, 2023</last_update_submitted>
    <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 5, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Indiana University School of Medicine</investigator_affiliation>
      <investigator_full_name>Rohan Dharmakumar</investigator_full_name>
      <investigator_title>Executive Director, Krannert Cardiovascular Research Center</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Coronary Artery Disease</mesh_term>
      <mesh_term>Myocardial Ischemia</mesh_term>
      <mesh_term>Coronary Disease</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/NCT06000540
  org study id: 15803
  nct id: NCT06000540
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  This is a prospective pilot study to evaluate the safety, tolerability and efficacy of
        utilizing precise computer controlled gas challenge in healthy subjects for identification of
        coronary artery disease.
  This study will establish the safe and tolerable level of high PC02 and low P02 for future
        studies as potential stressors for coronary artery disease assessment.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Physiological Parameters Monitoring
  time frame: 3 hours
  description: Saturation of peripheral oxygen as percentage
  Heart rate as beats per minute
  Noninvasive blood pressure as mmHg
  Partial pressure of oxygen as mmHg
  Partial pressure of carbon dioxide as mmHg
  measure: Assessment of Symptom Severity and Incidence
  time frame: 3 hours
  description: Chest pain
  Headache
  Dizziness
  Confusion
  Fatigue
  Upset stomach
  Nausea
  Vomiting
  arm group label: Healthy Subjects
  arm group type: Experimental
  description: Healthy subjects without a history of coronary artery disease will undergo computer-controlled gas challenges.
  intervention type: Device
  intervention name: RespirAct
  description: RespirAct device-based computer-controlled gas delivery at different concentrations as per protocol
  arm group label: Healthy Subjects
  criteria: 
  gender: All
  minimum age: 45 Years
  maximum age: 75 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Chandana Saha, PhD
  phone: 317 274 0975
  email: csaha@iu.edu
  facility: 
  contact: 
  investigator: 
  country: United States
  citation: Yang HJ, Dey D, Sykes J, Butler J, Biernaski H, Kovacs M, Bi X, Sharif B, Cokic I, Tang R, Slomka P, Prato FS, Dharmakumar R. Heart Rate-Independent 3D Myocardial Blood Oxygen Level-Dependent MRI at 3.0 T with Simultaneous 13N-Ammonia PET Validation. Radiology. 2020 Apr;295(1):82-93. doi: 10.1148/radiol.2020191456. Epub 2020 Feb 25.
  PMID: 32096705
  citation: Poublanc J, Sobczyk O, Shafi R, Sayin ES, Schulman J, Duffin J, Uludag K, Wood JC, Vu C, Dharmakumar R, Fisher JA, Mikulis DJ. Perfusion MRI using endogenous deoxyhemoglobin as a contrast agent: Preliminary data. Magn Reson Med. 2021 Dec;86(6):3012-3021. doi: 10.1002/mrm.28974. Epub 2021 Oct 22.
  PMID: 34687064
  citation: Spano VR, Mandell DM, Poublanc J, Sam K, Battisti-Charbonney A, Pucci O, Han JS, Crawley AP, Fisher JA, Mikulis DJ. CO2 blood oxygen level-dependent MR mapping of cerebrovascular reserve in a clinical population: safety, tolerability, and technical feasibility. Radiology. 2013 Feb;266(2):592-8. doi: 10.1148/radiol.12112795. Epub 2012 Nov 30.
  PMID: 23204541
  responsible party type: Sponsor-Investigator
  investigator affiliation: Indiana University School of Medicine
  investigator full name: Rohan Dharmakumar
  investigator title: Executive Director, Krannert Cardiovascular Research Center
  mesh term: Coronary Artery Disease
  mesh term: Myocardial Ischemia
  mesh term: Coronary Disease
  sharing ipd: No