Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients
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|ClinicalTrials.gov Identifier: NCT03255772|
Recruitment Status : Completed
First Posted : August 21, 2017
Last Update Posted : January 28, 2022
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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|
|Acute Coronary Syndrome Myocardial Infarction||Diagnostic Test: Magnetocardiography|
|Study Type :||Observational|
|Actual Enrollment :||101 participants|
|Official Title:||Magnetocardiography Using a Novel Analysis System (Cardioflux) in the Evaluation of Emergency Department Observation Unit Chest Pain Patients|
|Actual Study Start Date :||July 15, 2017|
|Actual Primary Completion Date :||December 30, 2017|
|Actual Study Completion Date :||May 1, 2018|
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 Name: Cardioflux Scan
- 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.
- 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.
- 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
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.
- ≤ 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
- Repeat participants
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03255772
|United States, Michigan|
|St. John Hospital and Medical Center|
|Detroit, Michigan, United States, 48236|
|Responsible Party:||Genetesis Inc.|
|Other Study ID Numbers:||
|First Posted:||August 21, 2017 Key Record Dates|
|Last Update Posted:||January 28, 2022|
|Last Verified:||January 2022|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||Undecided|
|Plan 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.|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||Yes|
|Device Product Not Approved or Cleared by U.S. FDA:||Yes|
|Product Manufactured in and Exported from the U.S.:||No|
Acute Coronary Syndrome