Acute Coronary Syndrome CardioFlux TM Study (ACCMED)

Completed

• Conditions: Acute Myocardial Injuries

• Registration Number: NCT04739267
• Lead Sponsor: Genetesis Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-27
• Study First Submitted: 2021-01-27
• Study First Submitted QC: 2021-02-01
• Study First Posted: 2021-02-04
• Primary Completion: 2022-11-30
• Study Completion: 2023-03-03
• Status Verified: 2023-05
• Last Update Submitted: 2023-05-10
• Last Update Posted: 2023-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 390

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To prove that MCG can accurately diagnose myocardial ischemia	1 year	Demonstrate the following: 1. MCG has a clinically acceptable sensitivity and specificity for the detection of myocardial ischemia. This will be compared to the Gold Standard of index revascularization, ≥70% stenosis in any coronary artery as determined by invasive coronary angiography, or 30-day MACE.; 2. MCG is non-inferior to noninvasive downstream testing (DS) for the identification of patients with myocardial ischemia.; 3. MCG is non-inferior to noninvasive downstream testing (DS) for appropriate referral of patients to invasive coronary angiography with decision to refer the patient to the coronary catheterization laboratory as the Gold Standard.

Secondary Outcome Measures

Name	Time	Method
To demonstrate that MCG provides value to the traditional HEART score for risk stratification of patients with suspected ACS.	1 year

Trial Locations

Locations (1)

Genetesis Facility; 🇺🇸 Mason, Ohio, United States