Clinical trial NCT04739267: Acute Coronary Syndrome CardioFlux TM Study (ACCMED)
Official title: The Acute Coronary Syndrome Accelerated CardioFlux TM Magnetocardiography-based Early Disposition Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Myocardial Injuries
Keywords: Ischemia
Cardiovascular Disease
MCG
CardioFlux
Lead sponsor: Genetesis Inc.
Sponsor class: INDUSTRY
First posted: 2021-02-04
Enrollment: 390
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting to the ED with symptoms of potential ACS and fitting the eligibility/exclusion criteria will be approached for accrual

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, 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.


Eligibility criteria: 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.

Primary outcomes:
measure: To prove that MCG can accurately diagnose myocardial ischemia
timeFrame: 1 year
Secondary outcomes:
measure: To demonstrate that MCG provides value to the traditional HEART score for risk stratification of patients with suspected ACS.
timeFrame: 1 year
Other outcomes:
Locations:
city: Mason
country: United States
facility: Genetesis Facility
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Sharon Mace, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Lee CC, Huang SS, Yeo YH, Hou YT, Park JY, Inoue K, Hsu WT. High-sensitivity-cardiac troponin for accelerated diagnosis of acute myocardial infarction: A systematic review and meta-analysis. Am J Emerg Med. 2020 Jul;38(7):1402-1407. doi: 10.1016/j.ajem.2019.11.035. Epub 2019 Dec 28.
citation: Madsen TE, Stewart M, Smyres C, Beal A, Hamilton D, Vlasic K, Oates A. Significance of an Indeterminate Troponin I in Patients Evaluated for Chest Pain in an Emergency Department Observation Unit. Crit Pathw Cardiol. 2015 Dec;14(4):146-9. doi: 10.1097/HPC.0000000000000054.
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