Status:
COMPLETED
Acute Coronary Syndrome CardioFlux TM Study (ACCMED)
Lead Sponsor:
Genetesis Inc.
Conditions:
Acute Myocardial Injuries
Eligibility:
All Genders
18+ years
Brief Summary
Approximately 16.5 million people suffer from coronary artery disease (CAD) and about 10 million present each year to emergency departments with symptoms like chest pain and shortness of breath, commo...
Eligibility Criteria
Inclusion
- ≥ 18 years of age at the time of enrollment.
- Patient presenting acutely with signs and symptoms suggestive of ACS.
- Informed Consent Form signed by subject or LAR.
- HEART Score of \>2.
- Patient consented within 4 hours of the beginning of the clinical assessment (exclusive of any screening examination) for suspected ACS by an appropriately credentialed clinician.
Exclusion
- \< 18 years of age.
- STEMI.
- Unable to fit into device.
- Non-ambulatory patients.
- Positive response on MCG metal checklist.
- Deemed hemodynamically unstable by treating physician, regardless of cause.
- Unable to lie supine for up to 5 minutes.
- Poor candidate for follow-up (e.g., no access to phone).
- Prisoners.
- Repeat participants.
Key Trial Info
Start Date :
January 27 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 3 2023
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT04739267
Start Date
January 27 2021
End Date
March 3 2023
Last Update
May 11 2023
Active Locations (1)
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1
Genetesis Facility
Mason, Ohio, United States, 45040