Status:
TERMINATED
Use of Magnetocardiography in Evaluation of Patients Going for Cardiac Catheterization
Lead Sponsor:
Genetesis Inc.
Conditions:
Acute Coronary Syndrome
Coronary Artery Stenosis
Eligibility:
All Genders
18+ years
Brief Summary
This is a multicenter, prospective trial to measure the test performance characteristics of the Magnetocardiography (MCG) CardioFlux cardiac diagnostic system in detecting clinically significant coron...
Detailed Description
This is a multicenter, prospective clinical trial studying the utility and accuracy of magnetocardiography (MCG) in identifying critical coronary artery obstruction responsible for myocardial ischemia...
Eligibility Criteria
Inclusion
- Age ≥ 18 years of age at the time of enrollment.
- Patient presenting acutely with signs and symptoms suggestive of Acute Coronary Syndrome (ACS) and in the opinion of the treating physician and based on best clinical assessment that a cardiac catheterization will be performed; or, had a positive stress test and is scheduled for cardiac catheterization.
- Patient's ability to lay supine for five minutes.
Exclusion
- Age \< 18 years of age
- Patients unable to fit into device
- Unable to transfer to device gantry
- Positive response on magnetocardiography (MCG) prescreening form
- Patients with claustrophobia or unable to lie supine for five minutes
- Pregnant women
- Poor candidate for follow-up (e.g. no access to phone)
- Repeat participants
- Prisoners
- Acute STEMI or hemodynamically unstable patients (Mean Arterial Pressure ≤ 65, Respiratory Rate ≥24, Heart Rate ≥105 bpm, Temperature\>38.1 or \<34 degrees Celsius, O2 Saturation\<90% despite oxygen therapy).
- Do not resuscitate order (DNR)
- Unable to have a cardiac catheterization secondary to dye, allergy, creatinine clearance, can't obtain access, etc.
Key Trial Info
Start Date :
May 15 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 4 2020
Estimated Enrollment :
101 Patients enrolled
Trial Details
Trial ID
NCT04044391
Start Date
May 15 2019
End Date
May 4 2020
Last Update
May 26 2020
Active Locations (2)
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1
Ascension St. John Medical Center
Detroit, Michigan, United States, 48236
2
Beaumont Hospital
Royal Oak, Michigan, United States, 48073