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Acute Coronary Syndrome CardioFlux TM Study (ACCMED)

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ClinicalTrials.gov Identifier: NCT04739267
Recruitment Status : Recruiting
First Posted : February 4, 2021
Last Update Posted : September 16, 2021
Sponsor:
Information provided by (Responsible Party):
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 and diagnostic accuracy of CardioFlux as an adjunctive diagnostic tool to rule-in/rule-out ACS in patients with symptoms suggestive of ACS, and evaluate the clinical and economic advantages of incorporating MCG into the triage pathway.

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

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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 2022
Estimated Study Completion Date : July 2022

Intervention Details:
  • Device: CardioFlux
    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
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT04739267


Contacts
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Contact: Anthony Senagore, M.D. 513-715-5045 anthony@genetesis.com
Contact: Samantha Legreaux, M.S. 513-715-5045 sam.legreaux@genetesis.com

Locations
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United States, Ohio
Genetesis Facility Recruiting
Mason, Ohio, United States, 45040
Contact: Sam Legreaux, M.S.    513-715-5045    sam.legreaux@genetesis.com   
Sponsors and Collaborators
Genetesis Inc.
Investigators
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Principal Investigator: Anthony Senagore, M.D. Genetesis Inc.
Publications:
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.
ClinicalTrials.gov Identifier: NCT04739267    
Other Study ID Numbers: 1000-2
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: September 16, 2021
Last Verified: September 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.:
Ischemia
Cardiovascular Disease
MCG
CardioFlux
Additional relevant MeSH terms:
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Acute Coronary Syndrome
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases