Ignite Creation Date:
2024-05-06 @ 1:14 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03968809
Status:
COMPLETED
Last Update Posted:
2023-02-23
First Post:
2019-05-28
Brief Title:
Role of Cardioflux in Predicting Coronary Artery Disease CAD Outcomes
Sponsor:
Genetesis Inc
Organization:
Genetesis Inc
Study Overview
Official Title:
Role of the Cardioflux Magnetocardiography System in Predicting Patient Outcomes With Coronary Artery Disease
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None