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

February 21, 2023 updated by: Genetesis Inc.

Role of the Cardioflux Magnetocardiography System in Predicting Patient Outcomes With Coronary Artery Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

101

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • J.W. Ruby Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
30 days
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
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Genetesis Inc.

Investigators

  • Principal Investigator: Partho P Sengupta, M.D., WVU Heart and Vascular Institute, J.W. Ruby Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2019

Primary Completion (Actual)

June 20, 2020

Study Completion (Actual)

June 20, 2020

Study Registration Dates

First Submitted

May 28, 2019

First Submitted That Met QC Criteria

May 28, 2019

First Posted (Actual)

May 30, 2019

Study Record Updates

Last Update Posted (Estimate)

February 23, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1902469303

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD 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.

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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