Skip to main content
OpenTrials
Completed

NCT Number: NCT03255772

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Coronary Syndrome Cardiovascular Diseases Chest Pain Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

St. John Hospital and Medical Center

Detroit, Michigan, 48236, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • ≤ 18 years of age
  • Patients unable to fit into device
  • Non-ambulatory patients
  • Patients with any implantable device or metal in the thorax area (e.g. pacemaker, AICD, bullet fragments in thorax)
  • Patients with claustrophobia
  • Pregnant women
  • Poor candidate for follow-up
  • Prisoners
  • Repeat participants

Treatment and study plan

Magnetocardiography

Diagnostic Test

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

Primary outcomes

  1. Identification of Active Myocardial Ischemia

    Time frame: 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

    Time frame: 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 outcomes

  1. Medium term Adverse Cardiac Events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Genetesis Inc.

Industry

Collaborators

  • St. John Hospital & Medical Center

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Aug 21, 2017
Registry last updated
Jan 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.