Acute Coronary Syndrome CardioFlux TM Study (ACCMED) (MAGNETO)

May 10, 2023 updated by: Genetesis Inc.

The Acute Coronary Syndrome Accelerated CardioFlux TM Magnetocardiography-based Early Disposition Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

390

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Mason, Ohio, United States, 45040
        • Genetesis Facility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To prove that MCG can accurately diagnose myocardial ischemia
Time Frame: 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.
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
To demonstrate that MCG provides value to the traditional HEART score for risk stratification of patients with suspected ACS.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genetesis Inc.

Investigators

  • Principal Investigator: Sharon Mace, M.D., The Cleveland Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 27, 2021

Primary Completion (Actual)

November 30, 2022

Study Completion (Actual)

March 3, 2023

Study Registration Dates

First Submitted

January 27, 2021

First Submitted That Met QC Criteria

February 1, 2021

First Posted (Actual)

February 4, 2021

Study Record Updates

Last Update Posted (Estimate)

May 11, 2023

Last Update Submitted That Met QC Criteria

May 10, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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