NCT06139094Completed
MCG for Suspected INOCA Confirmed by Thermodilution-Derived CFR
Magnetocardiography as a Noninvasive Diagnostic Strategy for Suspected Myocardial Ischemia With the Absence of Obstructive Coronary Artery Disease As Confirmed by Thermodilution-Derived CFR
Source: ClinicalTrials.gov · Last updated 31 May 2024
Brief summary (registry, in English)
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 disease, by using an invasive reference standard coronary flow reserve (CFR) measured using thermodilution for diagnosis. The device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with cloud processing software. A CardioFlux scan appointment shall last approximately 15 minutes in duration and include a patient questionnaire following the scan.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 48 (actual)
- First submitted
- 14 Nov 2023
- Start date
- 20 Dec 2023
- Primary completion date
- 13 May 2024
- Lead sponsor
- Genetesis Inc.
- Diseases
- Coronary artery disease
- NCT number
- NCT06139094
What you commit to
- Study type: Observational
- Participants enrolled: 48
- From 20 Dec 2023 to the primary completion date, 13 May 2024
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Documented acute coronary syndrome (ACS) within the previous 30 days.
- Concurrent enrollment in a clinical trial in which therapeutic intervention is administered within 30 days of enrollment.
Other illness
- History of non-ischemic dilated or hypertrophic cardiomyopathy.
- Moderate or severe valvular disease (including aortic stenosis or insufficiency).
- History of Left or Right Bundle Branch Block within 6 months of enrollment.
Lab values
- Known left ventricular ejection fraction (LVEF) \<45%, or hospitalization for Reduced ejection fraction within 180 days. (HFpEF is permitted).
- Estimated glomerular filtration rate (eGFR) \<30 ml/min.
Other
- 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.
- Currently in atrial fibrillation or atrial flutter at the time of enrollment.
- Life expectancy \<1-yrs. due to non-cardiovascular comorbidity.
- Pregnancy.
- Dextrocardia.
Who the study is looking for
- ≥ 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Christ Hospital Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| The Cleveland Clinic Foundation Coordinator of this site? Confirm its status | Cleveland | United States | Unknown status |
| Ascension St. John Hospital Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| University of Florida Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.