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

• ClinicalTrials.gov Identifier: NCT04739267
• Recruitment Status: Completed
• First Posted: February 4, 2021
• Last Update Posted: May 11, 2023
• Sponsor: Genetesis Inc.
• Information provided by (Responsible Party): Genetesis Inc.

Tracking Information

• First Submitted Date: January 27, 2021
• First Posted Date: February 4, 2021
• Last Update Posted Date: May 11, 2023
• Actual Study Start Date: January 27, 2021
• Actual Primary Completion Date: November 30, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 13, 2022)

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.

Original Primary Outcome Measures (submitted: February 1, 2021)

• Specificity statistics [ Time Frame: 6 months ]
  analyzing the specificity of CardioFlux
• Accuracy Statistics [ Time Frame: 6 months ]
  analyzing the accuracy of CardioFlux

• Current Secondary Outcome Measures (submitted: November 13, 2022): To demonstrate that MCG provides value to the traditional HEART score for risk stratification of patients with suspected ACS. [ Time Frame: 1 year ]
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Acute Coronary Syndrome CardioFlux TM Study (ACCMED)
• Official Title: The Acute Coronary Syndrome Accelerated CardioFlux TM Magnetocardiography-based Early Disposition Study
• 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.
• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• 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
• Condition: Acute Myocardial Injuries

Intervention

Device: CardioFlux

Not an intervention

• Study Groups/Cohorts: Not Provided

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.
• 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.
• 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.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 13, 2022): 390
• Original Estimated Enrollment (submitted: February 1, 2021): 600
• Actual Study Completion Date: March 3, 2023
• Actual Primary Completion Date: November 30, 2022 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Not Provided
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04739267
• Other Study ID Numbers: 1000-2
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Genetesis Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Genetesis Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Sharon Mace, M.D.; The Cleveland Clinic

• PRS Account: Genetesis Inc.
• Verification Date: May 2023