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Trial record 3 of 3 for:    genetesis

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

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ClinicalTrials.gov Identifier: NCT03968809
Recruitment Status : Not yet recruiting
First Posted : May 30, 2019
Last Update Posted : June 3, 2019
Sponsor:
Information provided by (Responsible Party):
Genetesis Inc.

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.


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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
Estimated Study Start Date : June 20, 2019
Estimated Primary Completion Date : June 20, 2020
Estimated Study Completion Date : June 20, 2020

Resource links provided by the National Library of Medicine


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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968809


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

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

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.

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Responsible Party: Genetesis Inc.
ClinicalTrials.gov Identifier: NCT03968809     History of Changes
Other Study ID Numbers: 1902469303
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: June 3, 2019
Last Verified: May 2019
Individual Participant Data (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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Genetesis Inc.:
Coronary Artery Disease
Cardiac Imaging
Additional relevant MeSH terms:
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Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases