Use of Magnetocardiography in Evaluation of Patients Going for Cardiac Catheterization

Acute Coronary Syndrome Clinical Trial

Official title:

Noninvasive Magnetocardiography Using the CardioFlux (TM) System in the Evaluation of Acute Coronary Syndrome Patients Going for Cardiac Catheterization

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04044391
• Other study ID #: 1345773
• Status: Terminated
• Start date: May 15, 2019
• Est. completion date: May 4, 2020

Study information

• Verified date: May 2020
• Source: Genetesis Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

This is a multicenter, prospective clinical trial studying the utility and accuracy of magnetocardiography (MCG) in identifying critical coronary artery obstruction responsible for myocardial ischemia. The study will enroll up to 1500 patients at high risk for coronary artery disease (CAD) who have been referred for cardiac catheterization. These patients will be recruited from an inpatient service post admission for chest pain or anginal equivalent or from a cohort of symptomatic patients who have failed outpatient stress testing. If they meet other stated inclusion criteria, they will have a 2 minute MCG scan prior to their cardiac catheterization. For comparative purposes, the first 300 patients will have an electrocardiogram (ECG) performed within 60 minutes of this initial scan.

After an enrolled study subject has had their catheterization procedure, the results of the catheterization will be reviewed by one of the study's primary investigators. If the subject has had a percutaneous coronary intervention (PCI), a second MCG scan will be performed prior to their discharge. The MCG scans will be interpreted by 3 physicians trained to read these images and blinded to all clinical information regarding study subjects.

The initial MCG scan will be evaluated for its sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and overall accuracy in detecting myocardial ischemia and critical coronary stenosis based on angiographic imaging, fractional flow reserve (FFR), or instant wave-free ratio (iFR) measurements, as applicable. The same statistical analysis will be performed for the ECGs performed on each of the applicable study subjects. When performed, the second MCG will be evaluated for any abnormalities after revascularization. These results will be used to determine the value of post-PCI MCG to predict 30 day and 180 day major adverse cardiac events (MACE)—specifically myocardial infarction or stroke, need for revascularization, or cardiac related death.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 101
• Est. completion date: May 4, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

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

Intervention

Diagnostic Test:
• CardioFlux Magnetocardiograph
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.

Locations

Country	Name	City	State
United States	Ascension St. John Medical Center	Detroit	Michigan
United States	Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Genetesis Inc.

Country where clinical trial is conducted

United States, 

References & Publications (10)

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. Review. — View Citation

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. — View Citation

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.

Hailer B, Chaikovsky I, Auth-Eisernitz S, Schäfer 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. — View Citation

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. Epub 2010 May 27. — View Citation

Kwong JS, Leithäuser 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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2006 May 29. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Incident of post-PCI MACE	Determine if residual abnormalities on post PCI MCG-CF maps can predict 30 day and 180 day MACE.	6 months
Secondary	Inter-reader reliability percentage	Measurement of consistency of interpretation among 3 physician readers of CardioFlux MCG scans.	6 months