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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04739267
Recruitment Status : Completed
First Posted : February 4, 2021
Last Update Posted : May 11, 2023
Sponsor:
Information provided by (Responsible Party):
Genetesis Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Acute Myocardial Injuries Device: CardioFlux

Study Design
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Study Type : Observational
Actual Enrollment : 390 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Acute Coronary Syndrome Accelerated CardioFlux TM Magnetocardiography-based Early Disposition Study
Actual Study Start Date : January 27, 2021
Actual Primary Completion Date : November 30, 2022
Actual Study Completion Date : March 3, 2023

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Device: CardioFlux
    Not an intervention

Outcome Measures
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Primary Outcome Measures :
  1. 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.


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04739267


Locations
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United States, Ohio
Genetesis Facility
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Genetesis Inc.
Investigators
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Principal Investigator: Sharon Mace, M.D. The Cleveland Clinic
More Information
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Publications:
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jimenez MC, Jordan LC, Judd SE, Lackland D, Lichtman JH, Lisabeth L, Liu S, Longenecker CT, Mackey RH, Matsushita K, Mozaffarian D, Mussolino ME, Nasir K, Neumar RW, Palaniappan L, Pandey DK, Thiagarajan RR, Reeves MJ, Ritchey M, Rodriguez CJ, Roth GA, Rosamond WD, Sasson C, Towfighi A, Tsao CW, Turner MB, Virani SS, Voeks JH, Willey JZ, Wilkins JT, Wu JH, Alger HM, Wong SS, Muntner P; American Heart Association Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2017 Update: A Report From the American Heart Association. Circulation. 2017 Mar 7;135(10):e146-e603. doi: 10.1161/CIR.0000000000000485. Epub 2017 Jan 25. No abstract available. Erratum In: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.

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Responsible Party: Genetesis Inc.
ClinicalTrials.gov Identifier: NCT04739267    
Other Study ID Numbers: 1000-2
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: May 11, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Genetesis Inc.:
Ischemia
Cardiovascular Disease
MCG
CardioFlux
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases