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Acute Coronary Syndrome CardioFlux TM Study (ACCMED)

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04739267
Recruitment Status : Recruiting
First Posted : February 4, 2021
Last Update Posted : February 4, 2021
Information provided by (Responsible Party):
Genetesis Inc.

Brief Summary:
To compare sensitivity and specificity of a CardioFlux based diagnostic algorithm versus standard of care assessment of potential acute coronary syndrome patients.

Condition or disease Intervention/treatment
Acute Myocardial Injuries Other: Not an intervention

Detailed Description:

To measure the test performance characteristics of the CardioFluxTM magnetocardiography diagnostic system in the early rule in/rule out detection of clinically significant myocardial ischemia in chest pain patients with a modified Heart Score (mHS)>2 on admission (without STEMI) to the emergency department to allow safe and timely disposition of the patient to an appropriate level of care. The study utilizes a "virtual" allocation to an MCG based care pathway to be compared to the standard of care pathway and outcomes.

All patients presenting to the emergency department with possible acute coronary syndrome with a modified heart score (mHS) >2 who are hemodynamically stable and without an ST elevation (STEMI) on admission ECG will be eligible for study inclusion. Patients will undergo an initial ECG, troponin blood draw, and MCG. All patients will be treated using standard of care (SOC) protocols without use of MCG results.

Patients will be allocated to the following virtual study "MCG pathways" by a blinded reviewer based upon the MCG test results: 1) non ischemic- Early Discharge (or considered eligible for evaluation of non-cardiac cause of symptoms); 2) Observation for evaluation of unstable angina without evidence of acute ischemia; or 3) ischemic- Early Cardiology Consult with directed evaluation/treatment.

The outcome measures will be NPV, PPV, sensitivity, specificity for CardioFlux magnetocardiography against ECG and/or troponin-based identification of cardiac ischemia/injury (ie STEMI or NSTEMI diagnosed by SOC pathway prior to discharge or coronary angiography). For the purposes of assessing true comparability, standard of care patients with indeterminate findings leading to observation care will be considered as false positive studies. Performance statistics (when data available) for cardiac catherization requiring revascularization (interventional or surgical) and 30-day MACE (if discharged by SOC) will be calculated for the Ischemic MCG group. The MCG Pathway patients will be compared to SOC for ED/CDU/OBS LOS and hospital charges.

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Study Type : Observational
Estimated Enrollment : 600 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
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Intervention Details:
  • Other: Not an intervention
    Not an intervention

Primary Outcome Measures :
  1. Specificity statistics [ Time Frame: 6 months ]
    analyzing the specificity of CardioFlux

  2. Accuracy Statistics [ Time Frame: 6 months ]
    analyzing the accuracy of CardioFlux

Information from the National Library of Medicine

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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

Inclusion Criteria:

  1. ≥ 18 years of age at the time of enrollment.
  2. Patient presenting with symptoms and signs consistent with ACS who do not have evidence of STEMI and/or hemodynamic instability on admission.
  3. Consents to having an MCG-CF study scan.
  4. Modified HEART score of 3-7

Exclusion Criteria:

  1. < 18 years of age
  2. Patients unable to fit into device
  3. Non-ambulatory patients
  4. Positive response on MCG Pre-Screening Form
  5. AF with RVR >120 bpm and/or hemodynamic instability
  6. Patients with claustrophobia or unable to lie supine for up to 5 minutes
  7. Pregnant women
  8. Poor candidate for follow-up (e.g. no access to phone)
  9. Prisoners
  10. Repeat participants
  11. STEMI

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 identifier (NCT number): NCT04739267

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Contact: Anthony Senagore, M.D. 513-715-5045
Contact: Samantha Legreaux, M.S. 513-715-5045

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United States, Ohio
Genetesis Facility Recruiting
Mason, Ohio, United States, 45040
Contact: Sam Legreaux, M.S.    513-715-5045   
Sponsors and Collaborators
Genetesis Inc.
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Principal Investigator: Anthony Senagore, M.D. Genetesis Inc.
Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez 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. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.

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Responsible Party: Genetesis Inc. Identifier: NCT04739267    
Other Study ID Numbers: 1000-2
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: February 4, 2021
Last Verified: February 2021
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.:
Cardiovascular Disease
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases