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Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients

Sponsor
Genetesis Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT03255772
Collaborator
St. John Hospital & Medical Center (Other)
101
Enrollment
1
Location
9.5
Actual Duration (Months)
10.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Magnetocardiography

Study Design

Study Type:
Observational
Actual Enrollment :
101 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients
Actual Study Start Date :
Jul 15, 2017
Actual Primary Completion Date :
Dec 30, 2017
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Acute Chest pain

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.

Diagnostic Test: Magnetocardiography
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.
Other Names:
  • Cardioflux Scan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Identification of Active Myocardial Ischemia [2 days]

      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.

    2. Identification of Active Myocardial Ischemia [1 week]

      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.

    Secondary Outcome Measures

    1. Medium term Adverse Cardiac Events [6 months]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No

    Inclusion Criteria: Low and intermediate risk ED patients presenting with chest pain of possible cardiac origin who have a negative first troponin result and non-diagnostic ECG that are to be placed in the Cardiac Diagnostic Unit (CDU) for further evaluation.

    Exclusion Criteria:

    1. ≤ 18 years of age

    2. Patients unable to fit into device

    3. Non-ambulatory patients

    4. Patients with any implantable device or metal in the thorax area (e.g. pacemaker, AICD, bullet fragments in thorax)

    5. Patients with claustrophobia

    6. Pregnant women

    7. Poor candidate for follow-up

    8. Prisoners

    9. Repeat participants

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St. John Hospital and Medical Center Detroit Michigan United States 48236

    Sponsors and Collaborators

    • Genetesis Inc.
    • St. John Hospital & Medical Center

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Genetesis Inc.
    ClinicalTrials.gov Identifier:
    NCT03255772
    Other Study ID Numbers:
    • 1053362-5
    First Posted:
    Aug 21, 2017
    Last Update Posted:
    Jan 28, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    Yes
    Product Manufactured in and Exported from the U.S.:
    No
    Keywords provided by Genetesis Inc.
    Magnetocardiography
    Chest pain
    Additional relevant MeSH terms:
    Myocardial Infarction
    Acute Coronary Syndrome
    Infarction
    Emergencies
    Chest Pain

    Study Results

    No Results Posted as of Jan 28, 2022