Status:
COMPLETED
MCG for Suspected INOCA Confirmed by Thermodilution-Derived CFR
Lead Sponsor:
Genetesis Inc.
Conditions:
Ischemic Heart Disease
Coronary Microvascular Disease
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
This observational registry study focuses on investigating the efficacy of magnetocardiography (MCG) in detecting myocardial ischemia secondary to coronary microvascular dysfunction (CMD) in the absen...
Eligibility Criteria
Inclusion
- ≥ 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
- 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.
Key Trial Info
Start Date :
December 20 2023
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 13 2024
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT06139094
Start Date
December 20 2023
End Date
May 13 2024
Last Update
May 31 2024
Active Locations (4)
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1
University of Florida
Gainesville, Florida, United States, 32608
2
Ascension St. John Hospital
Detroit, Michigan, United States, 48236
3
The Christ Hospital
Cincinnati, Ohio, United States, 45219
4
The Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195