Clinical trial NCT03968809: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: Coronary Artery Disease
Cardiac Imaging
Lead sponsor: Genetesis Inc.
Sponsor class: INDUSTRY
First posted: 2019-05-30
Enrollment: 101
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Percentage study subjects having coronary Revascularization
timeFrame: 1 year
measure: Percentage of study subjects having Major Adverse Cardiac Events
timeFrame: 1 year
measure: Incidence of study subjects with endpoint of death
timeFrame: 1 year
Secondary outcomes:
measure: Comparison of MCG with Stress testing
timeFrame: 30 days
measure: Comparison of MCG with Cardiac CT angiography (CCTA)
timeFrame: 30 days
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: J.W. Ruby Memorial Hospital
state: West Virginia
Study officials:
affiliation: WVU Heart and Vascular Institute, J.W. Ruby Memorial Hospital
name: Partho P Sengupta, M.D.
role: PRINCIPAL_INVESTIGATOR
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