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

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ClinicalTrials.gov Identifier: NCT03968809
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : November 21, 2019
Sponsor:
Information provided by (Responsible Party):
Genetesis Inc.

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 *

*   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