Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
NCT ID: NCT03968809
Last Updated: 2023-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
101 participants
OBSERVATIONAL
2019-09-05
2020-06-20
Brief Summary
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Detailed Description
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Multiple studies have shown that MCG accuracy is quite high in identifying patients with symptomatic coronary artery disease. This difference is dramatic enough to prove superiority over standard ECGs in diagnosis of vital ischemic and infarction parameters. Genetesis presents a novel MCG analysis system called CardioFlux (CF). This modality takes less than five minutes to complete, is radiation-free, and is an easy to operate system. This clinical trial will enroll patients of all cardiac risk levels presenting for various modalities of cardiac diagnostic testing to have CardioFlux scanning in addition to standard of care. Results will be interpreted and compared to the immediate results of nuclear (SPECT) stress testing, cardiac CT angiography, or cardiac catheterization.
Participants will be followed up at 30 days and 1 year via phone call or chart review. 30 day and 1 year MACE will be recorded and correlated with initial CardioFlux MCG results. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and overall accuracy will be calculated of CardioFlux relative to the incidence of MACE, and in comparison to the above diagnostic modalities.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
CardioFlux Magnetocardiography
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.
Interventions
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CardioFlux Magnetocardiography
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.
Eligibility Criteria
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Inclusion Criteria
* Patient presenting for cardiac stress testing, cardiac CT angiography (CCTA), or cardiac catheterization.
* Consents to having an magnetocardiogram-CardioFlux study scan.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Genetesis Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Partho P Sengupta, M.D.
Role: PRINCIPAL_INVESTIGATOR
WVU Heart and Vascular Institute, J.W. Ruby Memorial Hospital
Locations
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J.W. Ruby Memorial Hospital
Morgantown, West Virginia, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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1902469303
Identifier Type: -
Identifier Source: org_study_id
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