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MCG for Suspected INOCA Confirmed by Thermodilution-Derived CFR

NCT06139094 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 48

Last updated 2024-05-31

No results posted yet for this study

Summary

This study will be an observational registry to investigate the ability of magnetocardiography (MCG) in determining the presence of myocardial ischemia with the absence of obstructive coronary artery disease, by using an invasive reference standard coronary flow reserve (CFR) measured using thermodilution for diagnosis. The device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with cloud processing software. A CardioFlux scan appointment shall last approximately 15 minutes in duration and include a patient questionnaire following the scan.

Conditions

  • Ischemic Heart Disease
  • Coronary Microvascular Disease
  • Angina

Interventions

DEVICE

CardioFlux Magnetocardiography

The device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with a cloud processing software. CardioFlux devices are owned by Genetesis and are currently cleared for the acquisition, display, and analysis of magnetic fields generated by cardiac electrical activity (K182571, FDA clearance letter available for download online)

Sponsors & Collaborators

  • Genetesis Inc.

    lead INDUSTRY

Principal Investigators

  • Odayme E Quesada, MD · The Christ Hospital

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-20
Primary Completion
2024-05-13
Completion
2024-05-13
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06139094 on ClinicalTrials.gov