Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
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|ClinicalTrials.gov Identifier: NCT03968809|
Recruitment Status : Completed
First Posted : May 30, 2019
Last Update Posted : February 23, 2023
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|Condition or disease||Intervention/treatment|
|Coronary Artery Disease||Diagnostic Test: CardioFlux Magnetocardiography|
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|
|Actual Enrollment :||101 participants|
|Official Title:||Role of the Cardioflux Magnetocardiography System in Predicting Patient Outcomes With Coronary Artery Disease|
|Actual Study Start Date :||September 5, 2019|
|Actual Primary Completion Date :||June 20, 2020|
|Actual Study Completion Date :||June 20, 2020|
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.
- 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.
- 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
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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|
- ≥ 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.
- < 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)
- Repeat participants
- Patients participate in other research studies
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
|United States, West Virginia|
|J.W. Ruby Memorial Hospital|
|Morgantown, West Virginia, United States, 26506|
|Principal Investigator:||Partho P Sengupta, M.D.||WVU Heart and Vascular Institute, J.W. Ruby Memorial Hospital|
|Responsible Party:||Genetesis Inc.|
|Other Study ID Numbers:||
|First Posted:||May 30, 2019 Key Record Dates|
|Last Update Posted:||February 23, 2023|
|Last Verified:||February 2023|
|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.|
|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|
Coronary Artery Disease
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