MCG as a Noninvasive Diagnostic Strategy for Suspected INOCA (MICRO2)
NCT06212466 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 136
Last updated 2025-07-10
Summary
A prospective, multicenter, observational, single-arm trial to validate CardioFlux MCG's ability to diagnose myocardial ischemia caused by coronary microvascular dysfunction in patients with suspected ischemia and confirmed no obstructive coronary artery disease (suspected INOCA) by using diagnostic measures of coronary flow reserve (CFR) via invasive angiography as a reference standard for diagnosis.
Conditions
- Ischemic Heart Disease
- Coronary Microvascular Disease
- Angina
- Myocardial Ischemia
Interventions
- DEVICE
-
CardioFlux
The device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with a cloud processing software for the acquisition, display, and analysis of magnetic fields generated by cardiac electrical activity.
Sponsors & Collaborators
-
Genetesis Inc.
lead INDUSTRY
Principal Investigators
-
Zoe E Swann, PhD · Genetesis Inc.
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-06-03
- Primary Completion
- 2025-04-15
- Completion
- 2025-04-15
Countries
- United States
Study Locations
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