IRB Study Number 24-230
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
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.
Inclusion Criteria
Signs and symptoms of chest pain that prompted further evaluation by either a heart angiogram or a cardiac PET within the previous 5 years
0 to 49% diameter reduction of a major epicardial vessel by CT or Angiography
or a FFR>0.80 or iFR or RFR >0.89
Completed invasive CFR/angiogram (within 180 days of informed consent)
Exclusion Criteria
Patients who meet device contraindications. The MCG signal is not able to be interpreted in patients with the following:
Presence of ferromagnetic metal above the costal margin of the rib cage
Implanted pacemakers or cardioverter/defibrillators , Implanted infusion pumps and/or neuro stimulators
