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出境医 / 临床实验 / Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes

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

Study Description
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.

Condition or disease Intervention/treatment
Coronary Artery Disease Diagnostic Test: CardioFlux Magnetocardiography

Detailed Description:

This is a single-center, prospective, observational cohort trial to form a registry data set. Patients presenting for cardiac stress testing utilizing Single Photon Emission Computed Tomography (SPECT), cardiac CT angiography (CCTA), or cardiac catheterization will be offered to enroll in the registry and provide informed consent to undergo imaging with a CardioFlux magnetocardiography (MCG) prior to their procedure.

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Role of the Cardioflux Magnetocardiography System in Predicting Patient Outcomes With Coronary Artery Disease
Actual Study Start Date : September 5, 2019
Estimated Primary Completion Date : June 20, 2020
Estimated Study Completion Date : June 20, 2020
Arms and Interventions
Group/Cohort Intervention/treatment
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
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.
Outcome Measures
Primary Outcome Measures :
  1. Percentage study subjects having coronary Revascularization [ Time Frame: 1 year ]
    Patient follow up will be performed to find the incidence of coronary revascularization at 30 days and 1 year.

  2. Percentage of study subjects having Major Adverse Cardiac Events [ Time Frame: 1 year ]
    Patients will have follow up to determine the occurrence of MACE, defined as nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death

  3. Incidence of study subjects with endpoint of death [ Time Frame: 1 year ]
    All cause mortality will be recorded at end of follow up period for the entire study population.


Secondary Outcome Measures :
  1. Comparison of MCG with Stress testing [ Time Frame: 30 days ]
    Comparison with nuclear stress testing (SPECT) will be performed, with statistical analysis including sensitivity, specificity, NPV, and PPV

  2. Comparison of MCG with Cardiac CT angiography (CCTA) [ Time Frame: 30 days ]
    Comparison with CCTA will be performed for those having this test, with statistical analysis including sensitivity, specificity, NPV, and PPV


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • ≥ 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.

Exclusion Criteria:

  • < 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
Contacts and Locations

Contacts
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Contact: Partho P Sengupta, M.D. 855-988-2273 partho.sengupta@hsc.wvu.edu
Contact: Lan Hu, RN 304-598-4000 ext 77658 lan.hu@wvumedicine.org

Locations
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United States, West Virginia
J.W. Ruby Memorial Hospital Recruiting
Morgantown, West Virginia, United States, 26506
Contact: Partho Sengupta, M.D.    304-598-4000    partho.sengupta@hsc.wvu.edu   
Contact: Grace Verzosa, M.D.    304-598-4000 ext 72999    grace.verzosa@hsc.wvu.edu   
Sponsors and Collaborators
Genetesis Inc.
Investigators
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Principal Investigator: Partho P Sengupta, M.D. WVU Heart and Vascular Institute, J.W. Ruby Memorial Hospital
Tracking Information
First Submitted Date May 28, 2019
First Posted Date May 30, 2019
Last Update Posted Date November 21, 2019
Actual Study Start Date September 5, 2019
Estimated Primary Completion Date June 20, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 30, 2019)
  • Percentage study subjects having coronary Revascularization [ Time Frame: 1 year ]
    Patient follow up will be performed to find the incidence of coronary revascularization at 30 days and 1 year.
  • Percentage of study subjects having Major Adverse Cardiac Events [ Time Frame: 1 year ]
    Patients will have follow up to determine the occurrence of MACE, defined as nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
  • Incidence of study subjects with endpoint of death [ Time Frame: 1 year ]
    All cause mortality will be recorded at end of follow up period for the entire study population.
Original Primary Outcome Measures
 (submitted: May 28, 2019)
  • Revascularization [ Time Frame: 1 year ]
    Incidence of coronary revascularization at 30 days and 1 year.
  • Major Adverse Cardiac Events [ Time Frame: 1 year ]
    MACE defined as nonfatal stroke, nonfatal myocardial infarction, and cardiovascular death
  • Death [ Time Frame: 1 year ]
    All cause mortality
Change History
Current Secondary Outcome Measures
 (submitted: May 30, 2019)
  • Comparison of MCG with Stress testing [ Time Frame: 30 days ]
    Comparison with nuclear stress testing (SPECT) will be performed, with statistical analysis including sensitivity, specificity, NPV, and PPV
  • Comparison of MCG with Cardiac CT angiography (CCTA) [ Time Frame: 30 days ]
    Comparison with CCTA will be performed for those having this test, with statistical analysis including sensitivity, specificity, NPV, and PPV
Original Secondary Outcome Measures
 (submitted: May 28, 2019)
  • Stress testing [ Time Frame: 30 days ]
    Comparison with nuclear stress testing (SPECT) including sensitivity, specificity, NPV, and PPV
  • Cardiac CT angiography [ Time Frame: 30 days ]
    Comparison with CCTA including sensitivity, specificity, NPV, and PPV
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Official Title Role of the Cardioflux Magnetocardiography System in Predicting Patient Outcomes With Coronary Artery Disease
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.
Detailed Description

This is a single-center, prospective, observational cohort trial to form a registry data set. Patients presenting for cardiac stress testing utilizing Single Photon Emission Computed Tomography (SPECT), cardiac CT angiography (CCTA), or cardiac catheterization will be offered to enroll in the registry and provide informed consent to undergo imaging with a CardioFlux magnetocardiography (MCG) prior to their procedure.

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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Coronary Artery Disease
Intervention Diagnostic Test: 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.
Study Groups/Cohorts 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.
Intervention: Diagnostic Test: CardioFlux Magnetocardiography
Publications *
  • Benjamin EJ, Blaha MJ, Chiuve SE, Cushman M, Das SR, Deo R, de Ferranti SD, Floyd J, Fornage M, Gillespie C, Isasi CR, Jiménez 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. Review. Erratum in: Circulation. 2017 Mar 7;135(10 ):e646. Circulation. 2017 Sep 5;136(10 ):e196.
  • 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, 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.
  • 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.
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: May 28, 2019) 		400
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 20, 2020
Estimated Primary Completion Date June 20, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • ≥ 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.

Exclusion Criteria:

  • < 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Partho P Sengupta, M.D. 855-988-2273 partho.sengupta@hsc.wvu.edu
Contact: Lan Hu, RN 304-598-4000 ext 77658 lan.hu@wvumedicine.org
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03968809
Other Study ID Numbers 1902469303
Has Data Monitoring Committee Yes
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
Plan Description: Currently there is no plan to share independent participant data to other researchers outside the primary institution where the trial is taking place.
Responsible Party Genetesis Inc.
Study Sponsor Genetesis Inc.
Collaborators Not Provided
Investigators
Principal Investigator: Partho P Sengupta, M.D. WVU Heart and Vascular Institute, J.W. Ruby Memorial Hospital
PRS Account Genetesis Inc.
Verification Date November 2019

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