Use of Magnetocardiography in Evaluation of Patients Going for Cardiac Catheterization
Stopped early
Conditions studied: Acute Coronary Syndrome, Coronary Artery Stenosis, Myocardial Ischemia
In brief
This is a multicenter, prospective trial to measure the test performance characteristics of the Magnetocardiography (MCG) CardioFlux cardiac diagnostic system in detecting clinically significant coronary artery obstruction in patients with symptoms of suspected acute coronary syndrome or who present with a failed stress test with the intention of treat with cardiac catheterization.
Key facts
- Study ID
- NCT04044391
- Run by
- Genetesis Inc.
- People needed
- 101
- Starts
- 2019-05-15
- Expected to finish
- 2020-05-04
- Last updated by the study team
- 2020-05-26
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Ascension St. John Medical Center — Detroit, Michigan, United States
- Beaumont Hospital — Royal Oak, Michigan, United States
Full record on ClinicalTrials.gov
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