<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/NCT03255772</url>
  </required_header>
  <id_info>
    <org_study_id>1053362-5</org_study_id>
    <nct_id>NCT03255772</nct_id>
  </id_info>
  <brief_title>Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients</brief_title>
  <official_title>Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Genetesis Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>St. John Hospital &amp; Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Genetesis Inc.</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>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Genetesis is a cardiac diagnostics company which presents a novel magnetocardiogram (MCG)&#xD;
      analysis system called CardioFlux. This investigation presents a new, noninvasive diagnostic&#xD;
      option to use MCG for rapid diagnosis of acute coronary syndrome. Data from the Cardioflux&#xD;
      system will be compared with stress testing methods as well as the results of cardiac&#xD;
      catheterization to identify patients with myocardial ischemia.&#xD;
&#xD;
      This is a prospective observational single-blinded convenience pilot study of 100 patients&#xD;
      placed in the Clinical Decision Unit (CDU) for evaluation of chest pain at St. John Hospital&#xD;
      and Medical Center (Detroit, MI).&#xD;
&#xD;
      Patients enrolled in the study will also have a 30 and 180 day follow up for analysis of&#xD;
      adverse cardiac events.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 2017</start_date>
  <completion_date type="Actual">May 1, 2018</completion_date>
  <primary_completion_date type="Actual">December 30, 2017</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>Identification of Active Myocardial Ischemia</measure>
    <time_frame>2 days</time_frame>
    <description>Comparison of Magnetocardiography (MCG) and imaging of myocardial magnetic field/current will be performed directly with standard stress testing protocols performed on patients admitted to a cardiac observation unit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Identification of Active Myocardial Ischemia</measure>
    <time_frame>1 week</time_frame>
    <description>Comparison of Magnetocardiography (MCG) and imaging of magnetic field/current will be directly compared to cardiac catheterization data in those patients who undergo this procedure.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Medium term Adverse Cardiac Events</measure>
    <time_frame>6 months</time_frame>
    <description>In patients discharged from the cardiac observation unit with a negative stress test result, how does MCG results correlate with major adverse cardiac events (MACE) at 30 days and 6 months following discharge? MACE will be defined as acute myocardial infarction, coronary revascularization, and all-cause death.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">101</enrollment>
  <condition>Acute Coronary Syndrome</condition>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>Acute Chest pain</arm_group_label>
    <description>All patients admitted to the Clinical Decision Unit presenting to the Emergency Department (ED) with chest pain with risk factors suggesting a possible cardiac etiology.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Magnetocardiography</intervention_name>
    <description>Study subjects will be placed within a magnetic shielding apparatus. Noninvasive sensors placed over the subject's torso will acquire magnetic field fluctuations generated by cardiac activity, which will then be analyzed for evidence of myocardial ischemia.</description>
    <arm_group_label>Acute Chest pain</arm_group_label>
    <other_name>Cardioflux Scan</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study is a pilot study of 100 patients over the age of 18 years who are to be placed&#xD;
        in the CDU for evaluation of chest pain of possible cardiac origin will be eligible for the&#xD;
        MCG-CF scan based on eligibility criteria criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria: Low and intermediate risk ED patients presenting with chest pain of&#xD;
        possible cardiac origin who have a negative first troponin result and non-diagnostic ECG&#xD;
        that are to be placed in the Cardiac Diagnostic Unit (CDU) for further evaluation.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. ≤ 18 years of age&#xD;
&#xD;
          2. Patients unable to fit into device&#xD;
&#xD;
          3. Non-ambulatory patients&#xD;
&#xD;
          4. Patients with any implantable device or metal in the thorax area (e.g. pacemaker,&#xD;
             AICD, bullet fragments in thorax)&#xD;
&#xD;
          5. Patients with claustrophobia&#xD;
&#xD;
          6. Pregnant women&#xD;
&#xD;
          7. Poor candidate for follow-up&#xD;
&#xD;
          8. Prisoners&#xD;
&#xD;
          9. Repeat participants&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>St. John Hospital and Medical Center</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48236</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Chen Y, Fan Y, Yin Z, Zhang H, Zhang Y, Han Z, Wang C. Coronary computed tomographic angiography for patients with low-to-intermediate risk chest pain: A systematic review and meta-analysis. Oncotarget. 2017 Jan 10;8(2):2096-2103. doi: 10.18632/oncotarget.13782.</citation>
    <PMID>27926497</PMID>
  </reference>
  <reference>
    <citation>Hollander JE. The continuing search to identify the very-low-risk chest pain patient. Acad Emerg Med. 1999 Oct;6(10):979-81. doi: 10.1111/j.1553-2712.1999.tb01177.x. No abstract available.</citation>
    <PMID>10530653</PMID>
  </reference>
  <reference>
    <citation>Amsterdam EA, Kirk JD, Bluemke DA, Diercks D, Farkouh ME, Garvey JL, Kontos MC, McCord J, Miller TD, Morise A, Newby LK, Ruberg FL, Scordo KA, Thompson PD; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Cardiovascular Nursing, and Interdisciplinary Council on Quality of Care and Outcomes Research. Testing of low-risk patients presenting to the emergency department with chest pain: a scientific statement from the American Heart Association. Circulation. 2010 Oct 26;122(17):1756-76. doi: 10.1161/CIR.0b013e3181ec61df. Epub 2010 Jul 26. Erratum In: Circulation. 2010 Oct 26;122(17):e500-1.</citation>
    <PMID>20660809</PMID>
  </reference>
  <reference>
    <citation>Pollack CV Jr, Sites FD, Shofer FS, Sease KL, Hollander JE. Application of the TIMI risk score for unstable angina and non-ST elevation acute coronary syndrome to an unselected emergency department chest pain population. Acad Emerg Med. 2006 Jan;13(1):13-8. doi: 10.1197/j.aem.2005.06.031. Epub 2005 Dec 19.</citation>
    <PMID>16365321</PMID>
  </reference>
  <reference>
    <citation>Brindis RG, Douglas PS, Hendel RC, Peterson ED, Wolk MJ, Allen JM, Patel MR, Raskin IE, Hendel RC, Bateman TM, Cerqueira MD, Gibbons RJ, Gillam LD, Gillespie JA, Hendel RC, Iskandrian AE, Jerome SD, Krumholz HM, Messer JV, Spertus JA, Stowers SA; American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group; American Society of Nuclear Cardiology; American Heart Association. ACCF/ASNC appropriateness criteria for single-photon emission computed tomography myocardial perfusion imaging (SPECT MPI): a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group and the American Society of Nuclear Cardiology endorsed by the American Heart Association. J Am Coll Cardiol. 2005 Oct 18;46(8):1587-605. doi: 10.1016/j.jacc.2005.08.029. Erratum In: J Am Coll Cardiol. 2005 Dec 6;46(11):2148-50.</citation>
    <PMID>16226194</PMID>
  </reference>
  <reference>
    <citation>Chaikovsky I, Hailer B, Sosnytskyy V, Lutay M, Mjasnikov G, Kazmirchuk A, Bydnyk M, Lomakovskyy A, Sosnytskaja T. Predictive value of the complex magnetocardiographic index in patients with intermediate pretest probability of chronic coronary artery disease: results of a two-center study. Coron Artery Dis. 2014 Sep;25(6):474-84. doi: 10.1097/MCA.0000000000000107.</citation>
    <PMID>24667125</PMID>
  </reference>
  <reference>
    <citation>Lim HK, Chung N, Kim K, Ko YG, Kwon H, Lee YH, Kim JB, Cho JR, Kim JM, Kim IS, Park YK. Reproducibility of quantitative estimate of magnetocardiographic ventricular depolarization and repolarization parameters in healthy subjects and patients with coronary artery disease. Ann Biomed Eng. 2007 Jan;35(1):59-68. doi: 10.1007/s10439-006-9210-9. Epub 2006 Nov 7.</citation>
    <PMID>17089073</PMID>
  </reference>
  <reference>
    <citation>Goernig M, Liehr M, Tute C, Schlosser M, Haueisen J, Figulla HR, Leder U. Magnetocardiography based spatiotemporal correlation analysis is superior to conventional ECG analysis for identifying myocardial injury. Ann Biomed Eng. 2009 Jan;37(1):107-11. doi: 10.1007/s10439-008-9598-5. Epub 2008 Nov 18.</citation>
    <PMID>19015988</PMID>
  </reference>
  <reference>
    <citation>Tolstrup K, Madsen BE, Ruiz JA, Greenwood SD, Camacho J, Siegel RJ, Gertzen HC, Park JW, Smars PA. Non-invasive resting magnetocardiographic imaging for the rapid detection of ischemia in subjects presenting with chest pain. Cardiology. 2006;106(4):270-6. doi: 10.1159/000093490. Epub 2006 May 29.</citation>
    <PMID>16733351</PMID>
  </reference>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>August 17, 2017</study_first_submitted>
  <study_first_submitted_qc>August 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>January 26, 2022</last_update_submitted>
  <last_update_submitted_qc>January 26, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">January 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Magnetocardiography</keyword>
  <keyword>Chest pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Chest Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>All patient data will be redacted in terms of name, date of birth and identifying medical record numbers. Patients with specific clinical characteristics may be shared with other researchers if the current protocol is expanded to additional sites or continued within the same research site.</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/NCT03255772
org study id: 1053362-5
nct id: NCT03255772
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
Genetesis is a cardiac diagnostics company which presents a novel magnetocardiogram (MCG)
      analysis system called CardioFlux. This investigation presents a new, noninvasive diagnostic
      option to use MCG for rapid diagnosis of acute coronary syndrome. Data from the Cardioflux
      system will be compared with stress testing methods as well as the results of cardiac
      catheterization to identify patients with myocardial ischemia.

      This is a prospective observational single-blinded convenience pilot study of 100 patients
      placed in the Clinical Decision Unit (CDU) for evaluation of chest pain at St. John Hospital
      and Medical Center (Detroit, MI).

      Patients enrolled in the study will also have a 30 and 180 day follow up for analysis of
      adverse cardiac events.
observational model: Cohort
time perspective: Prospective
measure: Identification of Active Myocardial Ischemia
time frame: 2 days
description: Comparison of Magnetocardiography (MCG) and imaging of myocardial magnetic field/current will be performed directly with standard stress testing protocols performed on patients admitted to a cardiac observation unit.
measure: Identification of Active Myocardial Ischemia
time frame: 1 week
description: Comparison of Magnetocardiography (MCG) and imaging of magnetic field/current will be directly compared to cardiac catheterization data in those patients who undergo this procedure.
measure: Medium term Adverse Cardiac Events
time frame: 6 months
description: In patients discharged from the cardiac observation unit with a negative stress test result, how does MCG results correlate with major adverse cardiac events (MACE) at 30 days and 6 months following discharge? MACE will be defined as acute myocardial infarction, coronary revascularization, and all-cause death.
arm group label: Acute Chest pain
description: All patients admitted to the Clinical Decision Unit presenting to the Emergency Department (ED) with chest pain with risk factors suggesting a possible cardiac etiology.
intervention type: Diagnostic Test
intervention name: Magnetocardiography
description: Study subjects will be placed within a magnetic shielding apparatus. Noninvasive sensors placed over the subject's torso will acquire magnetic field fluctuations generated by cardiac activity, which will then be analyzed for evidence of myocardial ischemia.
arm group label: Acute Chest pain
other name: Cardioflux Scan
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Chen Y, Fan Y, Yin Z, Zhang H, Zhang Y, Han Z, Wang C. Coronary computed tomographic angiography for patients with low-to-intermediate risk chest pain: A systematic review and meta-analysis. Oncotarget. 2017 Jan 10;8(2):2096-2103. doi: 10.18632/oncotarget.13782.
PMID: 27926497
citation: Hollander JE. The continuing search to identify the very-low-risk chest pain patient. Acad Emerg Med. 1999 Oct;6(10):979-81. doi: 10.1111/j.1553-2712.1999.tb01177.x. No abstract available.
PMID: 10530653
citation: Amsterdam EA, Kirk JD, Bluemke DA, Diercks D, Farkouh ME, Garvey JL, Kontos MC, McCord J, Miller TD, Morise A, Newby LK, Ruberg FL, Scordo KA, Thompson PD; American Heart Association Exercise, Cardiac Rehabilitation, and Prevention Committee of the Council on Clinical Cardiology, Council on Cardiovascular Nursing, and Interdisciplinary Council on Quality of Care and Outcomes Research. Testing of low-risk patients presenting to the emergency department with chest pain: a scientific statement from the American Heart Association. Circulation. 2010 Oct 26;122(17):1756-76. doi: 10.1161/CIR.0b013e3181ec61df. Epub 2010 Jul 26. Erratum In: Circulation. 2010 Oct 26;122(17):e500-1.
PMID: 20660809
citation: Pollack CV Jr, Sites FD, Shofer FS, Sease KL, Hollander JE. Application of the TIMI risk score for unstable angina and non-ST elevation acute coronary syndrome to an unselected emergency department chest pain population. Acad Emerg Med. 2006 Jan;13(1):13-8. doi: 10.1197/j.aem.2005.06.031. Epub 2005 Dec 19.
PMID: 16365321
citation: Brindis RG, Douglas PS, Hendel RC, Peterson ED, Wolk MJ, Allen JM, Patel MR, Raskin IE, Hendel RC, Bateman TM, Cerqueira MD, Gibbons RJ, Gillam LD, Gillespie JA, Hendel RC, Iskandrian AE, Jerome SD, Krumholz HM, Messer JV, Spertus JA, Stowers SA; American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group; American Society of Nuclear Cardiology; American Heart Association. ACCF/ASNC appropriateness criteria for single-photon emission computed tomography myocardial perfusion imaging (SPECT MPI): a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group and the American Society of Nuclear Cardiology endorsed by the American Heart Association. J Am Coll Cardiol. 2005 Oct 18;46(8):1587-605. doi: 10.1016/j.jacc.2005.08.029. Erratum In: J Am Coll Cardiol. 2005 Dec 6;46(11):2148-50.
PMID: 16226194
citation: Chaikovsky I, Hailer B, Sosnytskyy V, Lutay M, Mjasnikov G, Kazmirchuk A, Bydnyk M, Lomakovskyy A, Sosnytskaja T. Predictive value of the complex magnetocardiographic index in patients with intermediate pretest probability of chronic coronary artery disease: results of a two-center study. Coron Artery Dis. 2014 Sep;25(6):474-84. doi: 10.1097/MCA.0000000000000107.
PMID: 24667125
citation: Lim HK, Chung N, Kim K, Ko YG, Kwon H, Lee YH, Kim JB, Cho JR, Kim JM, Kim IS, Park YK. Reproducibility of quantitative estimate of magnetocardiographic ventricular depolarization and repolarization parameters in healthy subjects and patients with coronary artery disease. Ann Biomed Eng. 2007 Jan;35(1):59-68. doi: 10.1007/s10439-006-9210-9. Epub 2006 Nov 7.
PMID: 17089073
citation: Goernig M, Liehr M, Tute C, Schlosser M, Haueisen J, Figulla HR, Leder U. Magnetocardiography based spatiotemporal correlation analysis is superior to conventional ECG analysis for identifying myocardial injury. Ann Biomed Eng. 2009 Jan;37(1):107-11. doi: 10.1007/s10439-008-9598-5. Epub 2008 Nov 18.
PMID: 19015988
citation: Tolstrup K, Madsen BE, Ruiz JA, Greenwood SD, Camacho J, Siegel RJ, Gertzen HC, Park JW, Smars PA. Non-invasive resting magnetocardiographic imaging for the rapid detection of ischemia in subjects presenting with chest pain. Cardiology. 2006;106(4):270-6. doi: 10.1159/000093490. Epub 2006 May 29.
PMID: 16733351
responsible party type: Sponsor
mesh term: Myocardial Infarction
mesh term: Acute Coronary Syndrome
mesh term: Infarction
mesh term: Emergencies
mesh term: Chest Pain
sharing ipd: Undecided
ipd description: All patient data will be redacted in terms of name, date of birth and identifying medical record numbers. Patients with specific clinical characteristics may be shared with other researchers if the current protocol is expanded to additional sites or continued within the same research site.