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Search / Trial NCT03968809

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

Launched by GENETESIS INC. · May 28, 2019

Trial Information

Current as of June 03, 2025

Completed

Keywords

Coronary Artery Disease Cardiac Imaging

ClinConnect Summary

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 super...

Gender

ALL

Eligibility criteria

  • 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

About Genetesis Inc.

Genetesis Inc. is a pioneering biotechnology company dedicated to advancing innovative solutions in the field of cardiovascular diagnostics. With a focus on developing non-invasive technologies, Genetesis leverages cutting-edge research to improve patient outcomes and enhance the accuracy of cardiac assessments. The company's commitment to clinical excellence is reflected in its rigorous clinical trials aimed at validating its proprietary diagnostic platforms, ultimately striving to transform the landscape of cardiovascular care. Through collaboration with healthcare professionals and institutions, Genetesis aims to deliver reliable, efficient, and accessible diagnostic tools that empower clinicians and benefit patients worldwide.

Locations

Morgantown, West Virginia, United States

Patients applied

0 patients applied

Trial Officials

Partho P Sengupta, M.D.

Principal Investigator

WVU Heart and Vascular Institute, J.W. Ruby Memorial Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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