Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes

NCT03968809 | Completed DMC FDA Device

• 1 other identifier: 1902469303
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

This single-center clinical trial is designed to evaluate the CardioFlux magnetocardiograph diagnostic imaging system to predict major adverse cardiac events (MACE) in patients referred for evaluation for coronary artery disease.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; Cardiac Imaging

Outcome Measures

Primary Outcomes (3)

• Percentage study subjects having coronary Revascularization

  Patient follow up will be performed to find the incidence of coronary revascularization at 30 days and 1 year.

  1 year

• Percentage of study subjects having Major Adverse Cardiac Events

  Patients will have follow up to determine the occurrence of MACE, defined as nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death

  1 year

• Incidence of study subjects with endpoint of death

  All cause mortality will be recorded at end of follow up period for the entire study population.

  1 year

Secondary Outcomes (2)

• Comparison of MCG with Stress testing

  30 days

• Comparison of MCG with Cardiac CT angiography (CCTA)

  30 days

Study Arms (1)

Standard Coronary Artery Disease Screening

All patients presenting for standard coronary artery disease screening will undergo additional imaging with CardioFlux MCG. These patients will be followed longitudinally for short and long term MACE.

Diagnostic Test: CardioFlux Magnetocardiography

Interventions

CardioFlux Magnetocardiography DIAGNOSTIC_TEST

All patients enrolled and receiving standard screening tests for CAD will undergo a 2 minute scan with MCG. It will be determined if MCG scanning can provide equal or superior accuracy to predict MACE than standard testing.

Standard Coronary Artery Disease Screening

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 is an adult patient population at varying risk for coronary artery disease who will present at single center for cardiovascular screening with stress testing, CCTA, or cardiac catheterization with angiography.

You may qualify if:

• ≥ 18 years of age at the time of enrollment.
• Patient presenting for cardiac stress testing, cardiac CT angiography (CCTA), or cardiac catheterization.
• Consents to having an magnetocardiogram-CardioFlux study scan.

You may not qualify if:

• \< 18 years of age
• Patients unable to fit into device
• Non-ambulatory patients
• Patients with implanted cardiac pacemakers/defibrillators
• Positive response on provided Metallic/Ferromagnetic Device Screening Form
• Atrial fibrillation with rapid ventricular response
• Patients with other sustained or incessant arrhythmias
• Patients with claustrophobia or unable to lie supine for 2 minutes
• Patients require supplemental oxygen at home
• Presence or reasonable clinical suspicion of any acute coronary syndrome for which delayed intervention could increase the risk or magnitude of damaged myocardium
• Patients scheduled for cardiac catheterization with indication of valvular disease
• Poor candidate for follow-up (e.g. no access to phone)
• Prisoners
• Repeat participants
• Patients participate in other research studies

Sponsors & Collaborators

• Genetesis Inc.: lead

Study Sites (1)

J.W. Ruby Memorial Hospital

Morgantown, West Virginia, 26506, United States

Location

Related Publications (9)

• 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. doi: 10.1161/CIR.0000000000000491. Circulation. 2017 Sep 5;136(10):e196. doi: 10.1161/CIR.0000000000000530.

  PMID: 28122885 BACKGROUND

• 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

• Goernig M, Liehr M, Tute C, Schlosser M, Haueisen J, Figulla HR, Leder U. Magnetocardiography based spatiotemporal correlation analysis is superior to conventional ECG analysis for identifying myocardial injury. Ann Biomed Eng. 2009 Jan;37(1):107-11. doi: 10.1007/s10439-008-9598-5. Epub 2008 Nov 18.

  PMID: 19015988 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

• 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

• 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

• Her AY, Park JW. Repolarization Heterogeneity of Magnetocardiography Predicts Long-Term Prognosis in Patients with Acute Myocardial Infarction. Yonsei Med J. 2016 Nov;57(6):1305-6. doi: 10.3349/ymj.2016.57.6.1305. No abstract available.

  PMID: 27593855 BACKGROUND

• Bang WD, Kim K, Lee YH, Kwon H, Park Y, Pak HN, Ko YG, Lee M, Joung B. Repolarization Heterogeneity of Magnetocardiography Predicts Long-Term Prognosis in Patients with Acute Myocardial Infarction. Yonsei Med J. 2016 Nov;57(6):1339-46. doi: 10.3349/ymj.2016.57.6.1339.

  PMID: 27593860 BACKGROUND

• Motwani M, Dey D, Berman DS, Germano G, Achenbach S, Al-Mallah MH, Andreini D, Budoff MJ, Cademartiri F, Callister TQ, Chang HJ, Chinnaiyan K, Chow BJ, Cury RC, Delago A, Gomez M, Gransar H, Hadamitzky M, Hausleiter J, Hindoyan N, Feuchtner G, Kaufmann PA, Kim YJ, Leipsic J, Lin FY, Maffei E, Marques H, Pontone G, Raff G, Rubinshtein R, Shaw LJ, Stehli J, Villines TC, Dunning A, Min JK, Slomka PJ. Machine learning for prediction of all-cause mortality in patients with suspected coronary artery disease: a 5-year multicentre prospective registry analysis. Eur Heart J. 2017 Feb 14;38(7):500-507. doi: 10.1093/eurheartj/ehw188.

  PMID: 27252451 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Partho P Sengupta, M.D.

  WVU Heart and Vascular Institute, J.W. Ruby Memorial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 30, 2019
• Study Start: September 5, 2019
• Primary Completion: June 20, 2020
• Study Completion: June 20, 2020
• Last Updated: February 23, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)