An observational study in Acute Coronary Syndrome and Myocardial Infarction, sponsored by Genetesis Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-28.
Sponsored by Genetesis Inc. · Observational
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.
This study is a pilot study of 100 patients over the age of 18 years who are to be placed in the CDU for evaluation of chest pain of possible cardiac origin will be eligible for the MCG-CF scan based on eligibility criteria criteria.
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:
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.
Also known as: Cardioflux Scan
Identification of Active Myocardial Ischemia
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.
Time frame: 2 days
Identification of Active Myocardial Ischemia
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.
Time frame: 1 week
Medium term Adverse Cardiac Events
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.
Time frame: 6 months
Plan to share: Undecided — 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.
This study is completed, as verified in Jan 2022. You cannot join it, but the record below documents what was studied.
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Genetesis Inc.