Use of Magnetocardiography in Evaluation of Patients Going for Cardiac Catheterization

NCT04044391 | Terminated DMC FDA Device

• 1 other identifier: 1345773
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 2

Brief Summary

This is a multicenter, prospective trial to measure the test performance characteristics of the Magnetocardiography (MCG) CardioFlux cardiac diagnostic system in detecting clinically significant coronary artery obstruction in patients with symptoms of suspected acute coronary syndrome or who present with a failed stress test with the intention of treat with cardiac catheterization.

Conditions

Acute Coronary Syndrome; Coronary Artery Stenosis; Myocardial Ischemia

Keywords

Coronary Artery Disease; Myocardial ischemia

Outcome Measures

Primary Outcomes (2)

• Accuracy of MCG to detect myocardial ischemia as determined by cardiac catheterization

  Assess accuracy of CardioFlux MCG (MCG-CF) and magnetic field map characteristics with findings of significant coronary artery stenosis ≥70% via angiography and/or via FFR of \<0.8 or via instant wave-free ratio (iFR) .

  72 hours

• Accuracy of MCG vs. ECG

  Compare CardioFlux MCG accuracy to ECG accuracy in identifying cardiac ischemia using coronary angiography with or without FFR/iFR as gold standard.

  72 hours

Secondary Outcomes (2)

• Incident of post-PCI MACE

  6 months

• Inter-reader reliability percentage

  6 months

Study Arms (2)

Intention to Treat: Cardiac Catheterization

All patients meeting inclusion criteria and scheduled to undergo cardiac catheterization will undergo a CardioFlux magnetocardiogram (MCG) to determine presence of patterns which indicate myocardial ischemia.

Diagnostic Test: CardioFlux Magnetocardiograph

Post Percutaneous Coronary Intervention

All patients found to have significant coronary artery obstruction seen via angiography +/- fractional flow reserve (FFR) or instant wave-free ratio (iFR) and who receive a catheter based intervention will have a post-procedure CardioFlux MCG scan. Follow up over the next 30 and 180 days will be performed to determine if a persistent pattern suggesting residual ischemia will correlate with an increased incidence of major cardiac adverse events (MACE).

Diagnostic Test: CardioFlux Magnetocardiograph

Interventions

CardioFlux Magnetocardiograph DIAGNOSTIC_TEST

CardioFlux is a noninvasive diagnostic modality which can measure and image the heart's intrinsic magnetic field created by ion transit across cardiac cell membranes.

Intention to Treat: Cardiac Catheterization; Post Percutaneous Coronary Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

This research study will enroll patients who will undergo cardiac catheterization because of symptoms and risk factors suggestive of acute coronary syndrome, and high risk patients presenting for cardiac catheterization due to an abnormal stress test. Patients meeting these criteria, and over the age of 18 years and all genders will be candidates.

You may qualify if:

• Age ≥ 18 years of age at the time of enrollment.
• Patient presenting acutely with signs and symptoms suggestive of Acute Coronary Syndrome (ACS) and in the opinion of the treating physician and based on best clinical assessment that a cardiac catheterization will be performed; or, had a positive stress test and is scheduled for cardiac catheterization.
• Patient's ability to lay supine for five minutes.

You may not qualify if:

• Age \< 18 years of age
• Patients unable to fit into device
• Unable to transfer to device gantry
• Positive response on magnetocardiography (MCG) prescreening form
• Patients with claustrophobia or unable to lie supine for five minutes
• Pregnant women
• Poor candidate for follow-up (e.g. no access to phone)
• Repeat participants
• Prisoners
• Acute STEMI or hemodynamically unstable patients (Mean Arterial Pressure ≤ 65, Respiratory Rate ≥24, Heart Rate ≥105 bpm, Temperature\>38.1 or \<34 degrees Celsius, O2 Saturation\<90% despite oxygen therapy).
• Do not resuscitate order (DNR)
• Unable to have a cardiac catheterization secondary to dye, allergy, creatinine clearance, can't obtain access, etc.

Sponsors & Collaborators

• Genetesis Inc.: lead

Study Sites (2)

Ascension St. John Medical Center

Detroit, Michigan, 48236, United States

Location

Beaumont Hospital

Royal Oak, Michigan, 48073, United States

Location

Related Publications (10)

• Chaikovsky I, Hailer B, Sosnytskyy V, Lutay M, Mjasnikov G, Kazmirchuk A, Bydnyk M, Lomakovskyy A, Sosnytskaja T. Predictive value of the complex magnetocardiographic index in patients with intermediate pretest probability of chronic coronary artery disease: results of a two-center study. Coron Artery Dis. 2014 Sep;25(6):474-84. doi: 10.1097/MCA.0000000000000107.

  PMID: 24667125 BACKGROUND

• Chen T, Z., C., Jiang, S, Van Leeuwen, P., Gronemeyer, D, Noninvasively diagnosing coronary artery disease with 61 channel MCG data. Chinese Science Bulletin. , 2014. 59: p. 1123.

  BACKGROUND

• Hailer B, Chaikovsky I, Auth-Eisernitz S, Schafer H, Van Leeuwen P. The value of magnetocardiography in patients with and without relevant stenoses of the coronary arteries using an unshielded system. Pacing Clin Electrophysiol. 2005 Jan;28(1):8-16. doi: 10.1111/j.1540-8159.2005.09318.x.

  PMID: 15660796 BACKGROUND

• Park JW, Hill PM, Chung N, Hugenholtz PG, Jung F. Magnetocardiography predicts coronary artery disease in patients with acute chest pain. Ann Noninvasive Electrocardiol. 2005 Jul;10(3):312-23. doi: 10.1111/j.1542-474X.2005.00634.x.

  PMID: 16029382 BACKGROUND

• Lim HK, Kwon H, Chung N, Ko YG, Kim JM, Kim IS, Park YK. Usefulness of magnetocardiogram to detect unstable angina pectoris and non-ST elevation myocardial infarction. Am J Cardiol. 2009 Feb 15;103(4):448-54. doi: 10.1016/j.amjcard.2008.10.013. Epub 2008 Dec 25.

  PMID: 19195500 BACKGROUND

• Li Y, Che Z, Quan W, Yuan R, Shen Y, Liu Z, Wang W, Jin H, Lu G. Diagnostic outcomes of magnetocardiography in patients with coronary artery disease. Int J Clin Exp Med. 2015 Feb 15;8(2):2441-6. eCollection 2015.

  PMID: 25932186 BACKGROUND

• Kwong JS, Leithauser B, Park JW, Yu CM. Diagnostic value of magnetocardiography in coronary artery disease and cardiac arrhythmias: a review of clinical data. Int J Cardiol. 2013 Sep 1;167(5):1835-42. doi: 10.1016/j.ijcard.2012.12.056. Epub 2013 Jan 19.

  PMID: 23336954 BACKGROUND

• Agarwal R, Saini A, Alyousef T, Umscheid CA. Magnetocardiography for the diagnosis of coronary artery disease: a systematic review and meta-analysis. Ann Noninvasive Electrocardiol. 2012 Oct;17(4):291-8. doi: 10.1111/j.1542-474X.2012.00538.x. Epub 2012 Aug 13.

  PMID: 23094875 BACKGROUND

• Kwon H, Kim K, Lee YH, Kim JM, Yu KK, Chung N, Ko YG. Non-invasive magnetocardiography for the early diagnosis of coronary artery disease in patients presenting with acute chest pain. Circ J. 2010 Jul;74(7):1424-30. doi: 10.1253/circj.cj-09-0975. Epub 2010 May 27.

  PMID: 20508380 BACKGROUND

• Tolstrup K, Madsen BE, Ruiz JA, Greenwood SD, Camacho J, Siegel RJ, Gertzen HC, Park JW, Smars PA. Non-invasive resting magnetocardiographic imaging for the rapid detection of ischemia in subjects presenting with chest pain. Cardiology. 2006;106(4):270-6. doi: 10.1159/000093490. Epub 2006 May 29.

  PMID: 16733351 BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome; Coronary Stenosis; Myocardial Ischemia; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Claire Pearson, M.D.

  Ascension St, John Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 1, 2019
• First Posted: August 5, 2019
• Study Start: May 15, 2019
• Primary Completion: March 1, 2020
• Study Completion: May 4, 2020
• Last Updated: May 26, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)