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

Genetesis

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Diagnostic Test: CardioFlux Magnetocardiography

Study type: Observational

Funder types: Industry

Identifiers

NCT03968809

1902469303

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

101 participants in 1 patient group

Standard Coronary Artery Disease Screening

Description:

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.

Treatment:

Diagnostic Test: CardioFlux Magnetocardiography