<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/NCT02240979</url>
  </required_header>
  <id_info>
    <org_study_id>HMRI-10Pico-1</org_study_id>
    <secondary_id>CIT2014</secondary_id>
    <nct_id>NCT02240979</nct_id>
  </id_info>
  <brief_title>Establishing a Non-invasive Method to Measure Your Heart's Performance</brief_title>
  <official_title>Establishing a Non-invasive Method to Measure Heart Performance</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Marie Csete MD, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Southern California</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>California Institute of Technology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Huntington Medical Research Institutes</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to evaluate a new way to examine cardiac function, using software&#xD;
      developed at Caltech. The experimental device is software loaded on an iPhone. The iPhone is&#xD;
      used to capture a pulse (waveform) by simply placing the iPhone lightly over the neck where&#xD;
      the carotid pulse can be felt. In this study the information collected from the iPhone app is&#xD;
      compared to cardiac function data obtained from the current gold standard for measuring&#xD;
      cardiac function, cardiac magnetic resonance imaging (MRI). Subjects referred from&#xD;
      cardiologists will also generally have echocardiography information available for comparison&#xD;
      with the iPhone app. For the study, subjects will have completely non-invasive studies done&#xD;
      in one setting: The iPhone app to capture the waveforms (over carotid and radial (wrist)&#xD;
      arteries), tonometry (another non-invasive method using a modified stethoscope), standard&#xD;
      pulse oximetry, followed by a 30 minute MRI examination of the heart. A second complete study&#xD;
      will be done about 6 months after the first. The complete study session takes about 1.5&#xD;
      hours.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators at Caltech have developed an iPhone-based application that allows them to&#xD;
      capture an arterial waveform using the iPhone camera held over the skin. Then based on the&#xD;
      captured waveform and previous laboratory experiments and models, the investigators are able&#xD;
      to calculate ejection fraction, the percentage of blood that goes out of the heart into the&#xD;
      circulation with each beat. Previous studies suggested that the iPhone app measurements of&#xD;
      ejection fraction were similar to those obtained with traditional cardiac echocardiography.&#xD;
      In the current study the iPhone app measures are being compared to ejection fraction obtained&#xD;
      using cardiac MRI. The iPhone also measures other physical properties of the heart and aorta&#xD;
      that the investigators call &quot;intrinsic frequencies&quot;. Using healthy subjects they have&#xD;
      established the normal pattern/range of intrinsic frequencies, and in this study, a more&#xD;
      diverse population of subjects (some with heart disease) will be studied, to determine how&#xD;
      intrinsic frequency measures compare to traditional clinical measures of cardiac function.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">May 2019</completion_date>
  <primary_completion_date type="Actual">May 2019</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>Magnetic resonance measures of cardiac function</measure>
    <time_frame>Within 1 month of study</time_frame>
    <description>Standard end-points of cardiac function such as chamber size and relaxation.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">72</enrollment>
  <condition>Heart Failure</condition>
  <arm_group>
    <arm_group_label>Adults able to undergo cardiac MRI exam</arm_group_label>
    <description>Adults able to undergo cardiac MRI</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>cardiac MRI</intervention_name>
    <description>cardiac MRI</description>
    <arm_group_label>Adults able to undergo cardiac MRI exam</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Adults with normal and abnormal cardiac function will be studied.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult age 18-90, outpatients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to lie flat for 30 minutes with periodic breath holding&#xD;
&#xD;
          -  Metal implants or other standard contraindications to MRI&#xD;
&#xD;
          -  Acute cardiac decompensation (active chest pain, shortness of breath)&#xD;
&#xD;
          -  Hypotension (SBP&lt;90 mm Hg)&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Patient too large to fit in closed MRI&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marie Csete, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Avicena LLC</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Niema Pahlevan, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Southern California</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Avicena LLC</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Huntington Medical Research Institutes MR Imaging Center</name>
      <address>
        <city>Pasadena</city>
        <state>California</state>
        <zip>91105</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Pahlevan NM, Tavallali P, Rinderknecht DG, Petrasek D, Matthews RV, Hou TY, Gharib M. Intrinsic frequency for a systems approach to haemodynamic waveform analysis with clinical applications. J R Soc Interface. 2014 Sep 6;11(98):20140617. doi: 10.1098/rsif.2014.0617.</citation>
    <PMID>25008087</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 12, 2014</study_first_submitted>
  <study_first_submitted_qc>September 15, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <last_update_submitted>May 10, 2019</last_update_submitted>
  <last_update_submitted_qc>May 10, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Huntington Medical Research Institutes</investigator_affiliation>
    <investigator_full_name>Marie Csete MD, PhD</investigator_full_name>
    <investigator_title>Chief Scientific Officer</investigator_title>
  </responsible_party>
  <keyword>arterial waveform</keyword>
  <keyword>cardiac magnetic resonance imaging</keyword>
  <keyword>echocardiography</keyword>
  <keyword>intrinsic frequency measures of cardiac function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>A manuscript was submitted in February 2016 reporting results of the study. In editorial process.</ipd_description>
  </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/NCT02240979
org study id: HMRI-10Pico-1
secondary id: CIT2014
nct id: NCT02240979
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
The purpose of the study is to evaluate a new way to examine cardiac function, using software
      developed at Caltech. The experimental device is software loaded on an iPhone. The iPhone is
      used to capture a pulse (waveform) by simply placing the iPhone lightly over the neck where
      the carotid pulse can be felt. In this study the information collected from the iPhone app is
      compared to cardiac function data obtained from the current gold standard for measuring
      cardiac function, cardiac magnetic resonance imaging (MRI). Subjects referred from
      cardiologists will also generally have echocardiography information available for comparison
      with the iPhone app. For the study, subjects will have completely non-invasive studies done
      in one setting: The iPhone app to capture the waveforms (over carotid and radial (wrist)
      arteries), tonometry (another non-invasive method using a modified stethoscope), standard
      pulse oximetry, followed by a 30 minute MRI examination of the heart. A second complete study
      will be done about 6 months after the first. The complete study session takes about 1.5
      hours.
Investigators at Caltech have developed an iPhone-based application that allows them to
      capture an arterial waveform using the iPhone camera held over the skin. Then based on the
      captured waveform and previous laboratory experiments and models, the investigators are able
      to calculate ejection fraction, the percentage of blood that goes out of the heart into the
      circulation with each beat. Previous studies suggested that the iPhone app measurements of
      ejection fraction were similar to those obtained with traditional cardiac echocardiography.
      In the current study the iPhone app measures are being compared to ejection fraction obtained
      using cardiac MRI. The iPhone also measures other physical properties of the heart and aorta
      that the investigators call "intrinsic frequencies". Using healthy subjects they have
      established the normal pattern/range of intrinsic frequencies, and in this study, a more
      diverse population of subjects (some with heart disease) will be studied, to determine how
      intrinsic frequency measures compare to traditional clinical measures of cardiac function.
observational model: Cohort
time perspective: Prospective
measure: Magnetic resonance measures of cardiac function
time frame: Within 1 month of study
description: Standard end-points of cardiac function such as chamber size and relaxation.
arm group label: Adults able to undergo cardiac MRI exam
description: Adults able to undergo cardiac MRI
intervention type: Device
intervention name: cardiac MRI
description: cardiac MRI
arm group label: Adults able to undergo cardiac MRI exam
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marie Csete, MD, PhD
role: Study Chair
affiliation: Avicena LLC
last name: Niema Pahlevan, PhD
role: Principal Investigator
affiliation: University of Southern California
facility: 
facility: 
country: United States
citation: Pahlevan NM, Tavallali P, Rinderknecht DG, Petrasek D, Matthews RV, Hou TY, Gharib M. Intrinsic frequency for a systems approach to haemodynamic waveform analysis with clinical applications. J R Soc Interface. 2014 Sep 6;11(98):20140617. doi: 10.1098/rsif.2014.0617.
PMID: 25008087
responsible party type: Sponsor-Investigator
investigator affiliation: Huntington Medical Research Institutes
investigator full name: Marie Csete MD, PhD
investigator title: Chief Scientific Officer
mesh term: Heart Failure
sharing ipd: Yes
ipd description: A manuscript was submitted in February 2016 reporting results of the study. In editorial process.