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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.
 
ClinicalTrials.gov Identifier: NCT04739267
Recruitment Status : Recruiting
First Posted : February 4, 2021
Last Update Posted : February 1, 2022
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 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

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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. Superiority of MCG to Standard of Care noninvasive testing for the diagnosis of myocardial ischemia. [ Time Frame: 1 year ]
    analyzing noninvasive testing for the diagnosis of myocardial ischemia

  2. Superiority of MCG to Standard of Care (SOC) in reducing length of stay [ Time Frame: 1 Year ]
    analyzing the difference in length of stay between CardioFlux and SOC



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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 enrolled 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.

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: February 1, 2022
Last Verified: January 2022
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