Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT06139094
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years of age at the time of enrollment.
* Signs and symptoms of coronary ischemia that prompted further evaluation by either invasive coronary angiography or coronary CT angiogram) within the previous 5 years.
* Willing to provide written informed consent.
* Non-obstructive CAD defined as: 0 to 49% diameter reduction of a major epicardial vessel or FFR\>0.80 (or non-hyperemic equivalent of iFR or RFR \>0.89)
* Completed invasive CFR via thermodilution method within 6 months of informed consent.
* Successfully passing CardioFlux's MCG ""Quality Preview" prior to MCG study scan.
Exclusion Criteria:
* Patients unable to fit into the CardioFlux device.
* Patients who meet device contraindications (as specified in section 1.4 of the protocol) NOTE: Sternotomy wires and stents are typically acceptable.
* Patients unable to lie supine for 5 minutes.
* History of non-ischemic dilated or hypertrophic cardiomyopathy.
* Documented acute coronary syndrome (ACS) within the previous 30 days.
* Known left ventricular ejection fraction (LVEF) \<45%, or hospitalization for Reduced ejection fraction within 180 days. (HFpEF is permitted).
* Currently in atrial fibrillation or atrial flutter at the time of enrollment.
* Estimated glomerular filtration rate (eGFR) \<30 ml/min.
* Moderate or severe valvular disease (including aortic stenosis or insufficiency).
* Life expectancy \<1-yrs. due to non-cardiovascular comorbidity.
* Concurrent enrollment in a clinical trial in which therapeutic intervention is administered within 30 days of enrollment.
* Pregnancy.
* Dextrocardia.
* History of Left or Right Bundle Branch Block within 6 months of enrollment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06139094
Study Brief:
Protocol Section:
NCT06139094