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

Completed

• Conditions: Coronary Artery Disease
• Interventions: Diagnostic Test: CardioFlux Magnetocardiography

• Registration Number: NCT03968809
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2019-05-28
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-30
• Study Start: 2019-09-05
• Primary Completion: 2020-06-20
• Study Completion: 2020-06-20
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 101

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard Coronary Artery Disease Screening	CardioFlux Magnetocardiography	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.

Primary Outcome Measures

Name	Time	Method
Percentage study subjects having coronary Revascularization	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	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	1 year	All cause mortality will be recorded at end of follow up period for the entire study population.

Secondary Outcome Measures

Name	Time	Method
Comparison of MCG with Cardiac CT angiography (CCTA)	30 days	Comparison with CCTA will be performed for those having this test, with statistical analysis including sensitivity, specificity, NPV, and PPV
Comparison of MCG with Stress testing	30 days	Comparison with nuclear stress testing (SPECT) will be performed, with statistical analysis including sensitivity, specificity, NPV, and PPV

Trial Locations

Locations (1)

J.W. Ruby Memorial Hospital; 🇺🇸 Morgantown, West Virginia, United States