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Acute Myocardial InjuriesMAGNETONCT04739267

Acute Coronary Syndrome CardioFlux TM Study (ACCMED)

An observational study of Acute Myocardial Injuries, run by Genetesis Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myocardial Injuries
What is being tested?
CardioFlux
Type of treatment
Medical device
How many people
390 participants
Where
1 siteUnited States
Study dates
27 Jan 2021to 3 Mar 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Adult, Older adult

Study population: All patients presenting to the ED with symptoms of potential ACS and fitting the eligibility/exclusion criteria will be approached for accrual

Who may be able to join

  • ≥ 18 years of age at the time of enrollment.
  • Patient presenting acutely with signs and symptoms suggestive of ACS.
  • Informed Consent Form signed by subject or LAR.
  • HEART Score of >2.
  • 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.

Who cannot join

  • < 18 years of age.
  • STEMI.
  • Unable to fit into device.
  • Non-ambulatory patients.
  • Positive response on MCG metal checklist.
  • Deemed hemodynamically unstable by treating physician, regardless of cause.
Show all 10Show fewer
  • Unable to lie supine for up to 5 minutes.
  • Poor candidate for follow-up (e.g., no access to phone).
  • Prisoners.
  • Repeat participants.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Genetesis Facility

    Mason, Ohio, 45040

Other trials in United States

About this study

Official title: 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.

Being tested
CardioFlux
Keywords
Ischemia, Cardiovascular Disease, MCG, CardioFlux
Medical subject headings
Ischemia, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CardioFluxDevice

    Not an intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To prove that MCG can accurately diagnose myocardial ischemia

    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.

    Measured: 1 year

Secondary outcomes (1)

  1. To demonstrate that MCG provides value to the traditional HEART score for risk stratification of patients with suspected ACS.

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2021
  2. Study start27 Jan 2021
  3. Primary completion30 Nov 2022
  4. Study completion3 Mar 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
390 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04739267
Sponsor's protocol ID
1000-2
Acronym
MAGNETO
Status last verified
May 2023
First submitted
27 Jan 2021
Last updated
11 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

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.

    PubMed 28122885

  • Yang G, Yao Y, Du Y, Huang J. Cardiac troponin had limited diagnostic value for acute myocardial infarction in renal insufficiency: a meta-analysis. Biomark Med. 2020 Apr;14(6):481-493. doi: 10.2217/bmm-2019-0339. Epub 2020 Apr 9.

    PubMed 32270694

  • Chiang CH, Chiang CH, Lee GH, Gi WT, Wu YK, Huang SS, Yeo YH, Giannitsis E, Lee CC. Safety and efficacy of the European Society of Cardiology 0/1-hour algorithm for diagnosis of myocardial infarction: systematic review and meta-analysis. Heart. 2020 Jul;106(13):985-991. doi: 10.1136/heartjnl-2019-316343. Epub 2020 Apr 3.

    PubMed 32245882

  • Lee CC, Huang SS, Yeo YH, Hou YT, Park JY, Inoue K, Hsu WT. High-sensitivity-cardiac troponin for accelerated diagnosis of acute myocardial infarction: A systematic review and meta-analysis. Am J Emerg Med. 2020 Jul;38(7):1402-1407. doi: 10.1016/j.ajem.2019.11.035. Epub 2019 Dec 28.

    PubMed 31932131

  • Madsen TE, Stewart M, Smyres C, Beal A, Hamilton D, Vlasic K, Oates A. Significance of an Indeterminate Troponin I in Patients Evaluated for Chest Pain in an Emergency Department Observation Unit. Crit Pathw Cardiol. 2015 Dec;14(4):146-9. doi: 10.1097/HPC.0000000000000054.

    PubMed 26569654

  • Madsen T, Perkins R, Holt B, Carlson M, Steenblik J, Bossart P, Hartsell S. Emergency Department Observation Unit Utilization Among Older Patients With Chest Pain. Crit Pathw Cardiol. 2019 Mar;18(1):19-22. doi: 10.1097/HPC.0000000000000166.

    PubMed 30747761

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Myocardial Injuries, run by Genetesis Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To prove that MCG can accurately diagnose myocardial ischemia (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04739267, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2023.

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