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/NCT06035107</url>
    </required_header>
    <id_info>
      <org_study_id>160695</org_study_id>
      <secondary_id>IRAS ID: 328944</secondary_id>
      <nct_id>NCT06035107</nct_id>
    </id_info>
    <brief_title>Contactless Radar Blood Pressure Validation</brief_title>
    <official_title>Clinical Validation of Contactless Radar Blood Pressure Device</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University College, London</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University College, London</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to learn how accurately blood pressure can be&#xD;
        measured using a contactless radar device.&#xD;
  &#xD;
        The main questions the study aims to answer are:&#xD;
  &#xD;
          1. how does blood pressure measured using radar compare with blood pressure using a cuff in&#xD;
             patients with known high blood pressure?&#xD;
  &#xD;
          2. how does blood pressure measured using radar compare with invasive blood pressure during&#xD;
             a coronary angiogram?&#xD;
  &#xD;
          3. can the radar blood pressure machine be used to measure blood pressuring during an MRI&#xD;
             scan of the heart?&#xD;
  &#xD;
          4. can the radar blood pressure machine be used to measure blood pressure during exercise?&#xD;
  &#xD;
        Participants in this study will have the following tests:&#xD;
  &#xD;
        Group 1: blood pressure measured with the radar device and a cuff when resting Group 2: blood&#xD;
        pressure measured with the radar device and by placing a small tube inside the arteries of&#xD;
        the wrist (during a clinical procedure) Group 3: blood pressure measured with the radar&#xD;
        device and a cuff during a cardiac MRI scan Group 4: blood pressure measured with the radar&#xD;
        device and a cuff during exercise&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        High blood pressure is the biggest risk factor for heart attacks and strokes. There are&#xD;
        several machines available for measuring blood pressure, but most of them need to contact the&#xD;
        skin causing discomfort from the inflatable cuff or risking the transmission of infections&#xD;
        from reusing cuffs. There are also situations where the cuff machines are inaccurate, such as&#xD;
        in older people or during exercise. Therefore, the investigators are trying to develop an&#xD;
        accurate contactless system for measuring blood pressure.&#xD;
  &#xD;
        The investigators have used advanced but safe radar to create a small machine with a camera&#xD;
        that can measure blood pressure from a distance without the need to contact the participant's&#xD;
        skin anywhere. It works by detecting tiny movements and changes on the skin produced from the&#xD;
        heartbeat and pulse that cannot be seen with the human eye. The investigators want to study&#xD;
        how accurate our radar blood pressure machine is by comparing it to other traditional methods&#xD;
        of measuring blood pressure.&#xD;
  &#xD;
        Firstly, radar blood pressure will be compared to auscultatory blood pressure (a blood&#xD;
        pressure system using a cuff) in a group of 25 participants at rest attending a specialist&#xD;
        blood pressure clinic. This is currently the internationally recommended method for&#xD;
        validating new blood pressure devices.&#xD;
  &#xD;
        Then radar blood pressure will be compared with invasive blood pressure (measured inside the&#xD;
        arteries by a small tube) in 50 participants undergoing clinically-indicated cardiac&#xD;
        catheterisation at the Royal Free Hospital.&#xD;
  &#xD;
        Next a radar device capable of measuring blood pressure in participants lying inside the&#xD;
        cardiovascular magnetic resonance (CMR) scanner will be developed. The radar blood pressure&#xD;
        derived in the CMR scanner will be compared to oscillometric blood pressure in 25&#xD;
        participants (a cuff-based BP system that is currently used in patients being scanned).&#xD;
        Finally, radar-BP will be compared with oscillometric BP in 50 participants during exercise&#xD;
        including sit-to-stand movements and using a bike ergometer.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2026</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2026</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>Radar blood pressure compared with blood pressure measured by manual auscultation</measure>
      <time_frame>3 years</time_frame>
      <description>To determine if the radar module can derive accurate blood pressure measurements when compared against non-invasive blood pressure measurements by manual auscultation in a group of participants with known hypertension.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Radar blood pressure compared with blood pressure measured invasively</measure>
      <time_frame>3 years</time_frame>
      <description>To compare the blood pressure measurements from the radar BP device with invasive blood pressure measurements obtained at the time of coronary angiography</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Radar blood pressure compared with oscillometric blood pressure during a cardiac MRI scan</measure>
      <time_frame>3 years</time_frame>
      <description>To compare the radar BP measurements with readings from an oscillometric cuff during a cardiac MR scan</description>
    </other_outcome>
    <other_outcome>
      <measure>Radar blood pressure compared with oscillometric blood pressure during exercise</measure>
      <time_frame>3 years</time_frame>
      <description>To compare the radar BP measurements with readings from an oscillometric cuff during exercise.</description>
    </other_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Blood Pressure</condition>
    <arm_group>
      <arm_group_label>Comparing radar and auscultatory blood pressure</arm_group_label>
      <description>25 participants will be recruited from a specialist hypertension clinic. These participants will undergo the following tests:&#xD;
  Questionnaire: The participant will be asked to complete a clinico-demographic questionnaire. This includes their demographic data and past medical history.&#xD;
  Measurement of height, weight and heart rate&#xD;
  Measurement of blood pressure using the radar device and using a cuff (called manual auscultation)&#xD;
  End of visit.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Comparing radar and invasive blood pressure</arm_group_label>
      <description>Participants will be recruited from a list of patients scheduled to attend the Royal Free Hospital catheterisation laboratory for a clinically-indicated invasive angiogram that was booked by their consultant. 50 participants aged 18 and over will be recruited.&#xD;
  The radar blood pressure measurements taken during the angiogram will not impact on the procedure or standard clinical care which the participant will receive. The duration of the visit is determined by the duration of the coronary angiogram and that is decided by the clinical care team. Participants will have the following tests:&#xD;
  Collection of baseline data including past medical history, current medication, height, weight and baseline ECG&#xD;
  Measurement of invasive blood pressure and radar blood pressure simultaneously before the rest of the procedure&#xD;
  End of visit.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Testing if the radar device can measure blood pressure in the MRI scanner</arm_group_label>
      <description>First we will develop a radar blood pressure device that can be used in the MRI scanner.&#xD;
  When this device has been proven to be safe, we will recruit 25 participants to have the following tests:&#xD;
  A questionnaire. The participant will be asked to complete a clinic-demographic questionnaire including their demographic data and past medical history.&#xD;
  Collection of blood test to assess kidney function. Additional blood tests will also be collected for storage and future analysis.&#xD;
  A cardiac MRI scan. Blood pressure will be measured at 5 minute intervals during the scan using an oscillometric cuff around the right upper arm. The radar device will measure blood pressure in a contactless way at the same time.&#xD;
  End of visit.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Testing if the radar device can measure blood pressure during exercise</arm_group_label>
      <description>We will recruit 50 participants the have the following tests:&#xD;
  Questionnaire: The participant will be asked to complete a clinico-demographic questionnaire. This includes their demographic data and past medical history.&#xD;
  Measurement of heart rate, breathing rate and oxygen saturations.&#xD;
  Recording a heart tracing called an ECG&#xD;
  Participants will then perform 5-10 minutes of exercise, either repeated sit-to-stand movements or using a bike ergometer. Blood pressure will be measured using a cuff and the radar device at regular intervals&#xD;
  Participants will then have a heart scan called an echocardiogram during which time the radar blood measurements will also be collected.&#xD;
  End of visit.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Radar blood pressure device</intervention_name>
      <description>The radar blood pressure device will be compared with other traditional blood pressure measurement methods.</description>
      <arm_group_label>Comparing radar and auscultatory blood pressure</arm_group_label>
      <arm_group_label>Comparing radar and invasive blood pressure</arm_group_label>
      <arm_group_label>Testing if the radar device can measure blood pressure during exercise</arm_group_label>
      <arm_group_label>Testing if the radar device can measure blood pressure in the MRI scanner</arm_group_label>
    </intervention>
    <biospec_retention>Samples With DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        25 participants will undergo radar blood pressure tests during an MRI scan of the heart. In&#xD;
        these participants, a point of care blood test will be taken to assess kidney function using&#xD;
        the StatSensor Xpress Creatinine monitor (Nova Biomedical, USA). Additional blood tests will&#xD;
        also be collected for storage and future DNA and small molecule analysis.&#xD;
  &#xD;
        The other participants will not have biospecimens stored.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Group 1: participants under the specialist hypertension clinic at the Royal Free Hospital&#xD;
          Group 2: participants who have been selected to undergo an angiogram by a consultant&#xD;
          cardiologist Group 3 and 4: healthy volunteers&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Group 1:&#xD;
  &#xD;
            -  Age &gt; 18 years old&#xD;
  &#xD;
            -  under the care of the complex hypertension clinic&#xD;
  &#xD;
            -  able to take auscultatory blood pressure from right arm&#xD;
  &#xD;
          Group 2:&#xD;
  &#xD;
            -  Age &gt;18&#xD;
  &#xD;
            -  has been selected to undergo invasive coronary angiogram by a consultant cardiologist&#xD;
  &#xD;
          Group 3:&#xD;
  &#xD;
            -  Age &gt;18&#xD;
  &#xD;
            -  willing to undergo a cardiac MRI scan&#xD;
  &#xD;
          Group 4:&#xD;
  &#xD;
          - Age &gt; 18&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Group 1&#xD;
  &#xD;
            -  anyone unable to consent&#xD;
  &#xD;
            -  inaudible Korotkoff K1/K5 sounds&#xD;
  &#xD;
            -  systolic BP difference &gt;12 mmHg and/or diastolic &gt;8 mmHg in any of the auscultatory&#xD;
               measurements during the validation study&#xD;
  &#xD;
            -  contraindication to cuff-based BP measurement e.g. lymph node clearance on right side&#xD;
  &#xD;
          Group 2:&#xD;
  &#xD;
            -  anyone unable to consent&#xD;
  &#xD;
            -  anyone in whom right radial arterial access cannot be obtained (e.g. severe skin&#xD;
               abnormality such as scleroderma)&#xD;
  &#xD;
            -  known arterio-venous malformation or fistulas in right arm&#xD;
  &#xD;
            -  any contraindication to an invasive angiogram such as severe frailty&#xD;
  &#xD;
          Group 3:&#xD;
  &#xD;
            -  anyone unable to consent&#xD;
  &#xD;
            -  anyone with a classical contraindication to an MRI study such as known metal fragments&#xD;
               allergy to used contrast&#xD;
  &#xD;
            -  high degree heart block&#xD;
  &#xD;
            -  asthma&#xD;
  &#xD;
          Group 4:&#xD;
  &#xD;
            -  anyone unable to consent&#xD;
  &#xD;
            -  anyone with exertional chest pain or known uncontrolled angina&#xD;
  &#xD;
            -  anyone with a known positive cardiac stress test.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Gabriella Captur, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>University College, London</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Debbie Falconer, MBBS</last_name>
      <phone>07984548291</phone>
      <email>debbie.falconer@nhs.net</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Gabriella Captur, PhD</last_name>
      <phone>02076705702</phone>
      <email>gabriella.captur@ucl.ac.uk</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>UCL Bloomsbury Centre for Clinical Phenotyping</name>
        <address>
          <city>London</city>
          <zip>SW13 0JD</zip>
          <country>United Kingdom</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 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>
    <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/NCT06035107
  org study id: 160695
  secondary id: IRAS ID: 328944
  nct id: NCT06035107
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this observational study is to learn how accurately blood pressure can be
        measured using a contactless radar device.
  
        The main questions the study aims to answer are:
  
          1. how does blood pressure measured using radar compare with blood pressure using a cuff in
             patients with known high blood pressure?
  
          2. how does blood pressure measured using radar compare with invasive blood pressure during
             a coronary angiogram?
  
          3. can the radar blood pressure machine be used to measure blood pressuring during an MRI
             scan of the heart?
  
          4. can the radar blood pressure machine be used to measure blood pressure during exercise?
  
        Participants in this study will have the following tests:
  
        Group 1: blood pressure measured with the radar device and a cuff when resting Group 2: blood
        pressure measured with the radar device and by placing a small tube inside the arteries of
        the wrist (during a clinical procedure) Group 3: blood pressure measured with the radar
        device and a cuff during a cardiac MRI scan Group 4: blood pressure measured with the radar
        device and a cuff during exercise
  High blood pressure is the biggest risk factor for heart attacks and strokes. There are
        several machines available for measuring blood pressure, but most of them need to contact the
        skin causing discomfort from the inflatable cuff or risking the transmission of infections
        from reusing cuffs. There are also situations where the cuff machines are inaccurate, such as
        in older people or during exercise. Therefore, the investigators are trying to develop an
        accurate contactless system for measuring blood pressure.
  
        The investigators have used advanced but safe radar to create a small machine with a camera
        that can measure blood pressure from a distance without the need to contact the participant's
        skin anywhere. It works by detecting tiny movements and changes on the skin produced from the
        heartbeat and pulse that cannot be seen with the human eye. The investigators want to study
        how accurate our radar blood pressure machine is by comparing it to other traditional methods
        of measuring blood pressure.
  
        Firstly, radar blood pressure will be compared to auscultatory blood pressure (a blood
        pressure system using a cuff) in a group of 25 participants at rest attending a specialist
        blood pressure clinic. This is currently the internationally recommended method for
        validating new blood pressure devices.
  
        Then radar blood pressure will be compared with invasive blood pressure (measured inside the
        arteries by a small tube) in 50 participants undergoing clinically-indicated cardiac
        catheterisation at the Royal Free Hospital.
  
        Next a radar device capable of measuring blood pressure in participants lying inside the
        cardiovascular magnetic resonance (CMR) scanner will be developed. The radar blood pressure
        derived in the CMR scanner will be compared to oscillometric blood pressure in 25
        participants (a cuff-based BP system that is currently used in patients being scanned).
        Finally, radar-BP will be compared with oscillometric BP in 50 participants during exercise
        including sit-to-stand movements and using a bike ergometer.
  observational model: Cohort
  time perspective: Prospective
  measure: Radar blood pressure compared with blood pressure measured by manual auscultation
  time frame: 3 years
  description: To determine if the radar module can derive accurate blood pressure measurements when compared against non-invasive blood pressure measurements by manual auscultation in a group of participants with known hypertension.
  measure: Radar blood pressure compared with blood pressure measured invasively
  time frame: 3 years
  description: To compare the blood pressure measurements from the radar BP device with invasive blood pressure measurements obtained at the time of coronary angiography
  measure: Radar blood pressure compared with oscillometric blood pressure during a cardiac MRI scan
  time frame: 3 years
  description: To compare the radar BP measurements with readings from an oscillometric cuff during a cardiac MR scan
  measure: Radar blood pressure compared with oscillometric blood pressure during exercise
  time frame: 3 years
  description: To compare the radar BP measurements with readings from an oscillometric cuff during exercise.
  arm group label: Comparing radar and auscultatory blood pressure
  description: 25 participants will be recruited from a specialist hypertension clinic. These participants will undergo the following tests:
  Questionnaire: The participant will be asked to complete a clinico-demographic questionnaire. This includes their demographic data and past medical history.
  Measurement of height, weight and heart rate
  Measurement of blood pressure using the radar device and using a cuff (called manual auscultation)
  End of visit.
  arm group label: Comparing radar and invasive blood pressure
  description: Participants will be recruited from a list of patients scheduled to attend the Royal Free Hospital catheterisation laboratory for a clinically-indicated invasive angiogram that was booked by their consultant. 50 participants aged 18 and over will be recruited.
  The radar blood pressure measurements taken during the angiogram will not impact on the procedure or standard clinical care which the participant will receive. The duration of the visit is determined by the duration of the coronary angiogram and that is decided by the clinical care team. Participants will have the following tests:
  Collection of baseline data including past medical history, current medication, height, weight and baseline ECG
  Measurement of invasive blood pressure and radar blood pressure simultaneously before the rest of the procedure
  End of visit.
  arm group label: Testing if the radar device can measure blood pressure in the MRI scanner
  description: First we will develop a radar blood pressure device that can be used in the MRI scanner.
  When this device has been proven to be safe, we will recruit 25 participants to have the following tests:
  A questionnaire. The participant will be asked to complete a clinic-demographic questionnaire including their demographic data and past medical history.
  Collection of blood test to assess kidney function. Additional blood tests will also be collected for storage and future analysis.
  A cardiac MRI scan. Blood pressure will be measured at 5 minute intervals during the scan using an oscillometric cuff around the right upper arm. The radar device will measure blood pressure in a contactless way at the same time.
  End of visit.
  arm group label: Testing if the radar device can measure blood pressure during exercise
  description: We will recruit 50 participants the have the following tests:
  Questionnaire: The participant will be asked to complete a clinico-demographic questionnaire. This includes their demographic data and past medical history.
  Measurement of heart rate, breathing rate and oxygen saturations.
  Recording a heart tracing called an ECG
  Participants will then perform 5-10 minutes of exercise, either repeated sit-to-stand movements or using a bike ergometer. Blood pressure will be measured using a cuff and the radar device at regular intervals
  Participants will then have a heart scan called an echocardiogram during which time the radar blood measurements will also be collected.
  End of visit.
  intervention type: Diagnostic Test
  intervention name: Radar blood pressure device
  description: The radar blood pressure device will be compared with other traditional blood pressure measurement methods.
  arm group label: Comparing radar and auscultatory blood pressure
  arm group label: Comparing radar and invasive blood pressure
  arm group label: Testing if the radar device can measure blood pressure during exercise
  arm group label: Testing if the radar device can measure blood pressure in the MRI scanner
  25 participants will undergo radar blood pressure tests during an MRI scan of the heart. In
        these participants, a point of care blood test will be taken to assess kidney function using
        the StatSensor Xpress Creatinine monitor (Nova Biomedical, USA). Additional blood tests will
        also be collected for storage and future DNA and small molecule analysis.
  
        The other participants will not have biospecimens stored.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gabriella Captur, PhD
  role: Principal Investigator
  affiliation: University College, London
  last name: Debbie Falconer, MBBS
  phone: 07984548291
  email: debbie.falconer@nhs.net
  last name: Gabriella Captur, PhD
  phone: 02076705702
  email: gabriella.captur@ucl.ac.uk
  facility: 
  country: United Kingdom
  responsible party type: Sponsor
  sharing ipd: No