Magnetocardiography as a Noninvasive Diagnostic Strategy for Suspected Coronary Microvascular Dysfunction (Pivotal).
A prospective, multicenter, observational, single-arm trial to validate CardioFlux MCG’s ability to diagnose myocardial ischemia caused by coronary microvascular dysfunction (CMD) 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.
Men and women aged 18 years and older with chronic/stable angina and no obstructive coronary artery disease (suspected INOCA) with an invasive CFR measurement taken at an enrolling clinical trial center.
Study participation will span up to 2 weeks for completion of all timepoint visits (i.e. informed consent, MCG scan, and follow-up phone call). A CardioFlux scan appointment shall last approximately 15 minutes in duration (5 minutes for patient preparation, 5 minutes for the scan, and 5 minutes for patient survey).
Primary Endpoint:
Diagnostic accuracy of CardioFlux MCG in determining the presence of coronary microvascular dysfunction, as measured by AUC with ground truth defined as an invasive CFR <2.5 for bolus thermodilution method.
H0: AUC<0.55
Ha: AUC≥0.55
Key Secondary Endpoints:
Key Secondary Endpoint 1: Sensitivity and specificity of CardioFlux MCG in determining the presence of CMD with the gold standard defined as an invasive CFR <2.5 for thermodilution method as determined by a positive MCG scan output.
Sensitivity
H0<0.30
Ha≥0.30
Specificity
H0<0.70
Ha ≥0.70
Key Secondary Endpoint 2: Sensitivity and specificity of CardioFlux MCG in determining the presence of CMD with the gold standard defined as an invasive CFR <2.5 for thermodilution method as determined by a positive MCG scan output.
Sensitivity
H0<0.70
Ha≥0.70
Specificity
H0<0.30
Ha ≥0.30
Secondary Endpoints: