Acute Coronary Syndrome CardioFlux TM Study (ACCMED)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

390 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-27

Study Completion Date

2023-03-03

Brief Summary

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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, commonly suggestive of acute coronary syndrome (ACS). To clinically assess ACS risk in these patients, there are typically 2-6 hours of emergency room evaluation, followed by 6-42 hours of an observation period prior to discharge. The clinical pathway includes: 1) 1-3 ECG's; 2) serial troponins (1 and 3 hours vs 1 and 6 hours); and 3) other pertinent diagnostic information, including but not limited to echocardiography, stress testing and/or CT Angiography. Patients who are evaluated, have presented with a low risk for ACS, and maintain negative diagnostic results can potentially be discharged within 6 hours. However, 20%-40% of patients who fall into indeterminate diagnostic categories will require longer observation periods or admission of 12-48 hours which result in the use of expensive imaging and provocative testing, such as stress testing. The purpose of ACCMED is to measure the efficacy of Magnetocardiography (MCG) as a diagnostic tool to rule-in/rule-out myocardial ischemia in patients with suspicion of an acute coronary syndrome who have a HEART Score \> 2 and to allow safe and timely disposition of the patient to an appropriate level of care.

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Detailed Description

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Conditions

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Acute Myocardial Injuries

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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CardioFlux

Not an intervention

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. ≥ 18 years of age at the time of enrollment.
2. Patient presenting acutely with signs and symptoms suggestive of ACS.
3. Informed Consent Form signed by subject or LAR.
4. HEART Score of \>2.
5. 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 Criteria

1. \< 18 years of age.
2. STEMI.
3. Unable to fit into device.
4. Non-ambulatory patients.
5. Positive response on MCG metal checklist.
6. Deemed hemodynamically unstable by treating physician, regardless of cause.
7. Unable to lie supine for up to 5 minutes.
8. Poor candidate for follow-up (e.g., no access to phone).
9. Prisoners.
10. Repeat participants.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No