MCG as a Noninvasive Diagnostic Strategy for Suspected INOCA (MICRO2)

Launched by GENETESIS INC. · Jan 8, 2024

Keywords

ClinConnect Summary

The MICRO2 trial is studying a new way to diagnose heart problems known as myocardial ischemia, which can occur when the small blood vessels in the heart aren't working properly. This condition can cause chest pain, even when there are no blockages in the larger coronary arteries. The researchers want to see if a device called CardioFlux MCG can accurately identify this issue in patients who have experienced chest pain and who have recently undergone a test called coronary flow reserve (CFR) to check their heart's blood flow.

To take part in this study, participants must be at least 18 years old and willing to provide consent. They should have had symptoms of chest pain that led to a coronary angiogram within the last five years and need to have had a CFR test done recently. Participants will undergo the CardioFlux MCG test, which is noninvasive and requires them to lie comfortably for about five minutes. Overall, the trial aims to improve the way doctors diagnose heart issues in patients without blockages in their main coronary arteries, helping to ensure they receive the right treatment.

Gender

ALL

Eligibility criteria

• • INCLUSION CRITERIA
• In order to be eligible to participate in this study, an individual must meet all the following criteria:
• • 1. ≥ 18 years of age at the time of enrollment.
• • 2. Willing to provide written informed consent.
• • 3. Signs and symptoms of chest pain prompted further evaluation by a coronary angiogram within the previous 5 years.
• • 4. Invasive CFR (via bolus thermodilution) completed within 180 days, or scheduled within 30 days, of informed consent.
• • 4.1. CFR must be performed in the mid Left Anterior Descending (LAD) vessel.
• • 5. Successfully passing CardioFlux MCG Quality Preview prior to MCG study scan. 5.1. Patients must be able to fit into the device. 5.2. Patients must be able to lie supine for 5 minutes. 5.3. Patients must not have any of the following: 5.3.1. Presence of ferromagnetic metal between the sternal notch and costal margin of the rib cage.
• • 5.3.2. Implanted pacemakers or cardioverter/defibrillators. 5.3.3. Implanted infusion pumps and/or neuro stimulators. 5.3.4. Note: sternotomy wires and stents are acceptable. 5.3.5. Note: Failure to meet inclusion criteria 5.3 will render the MCG scan uninterpretable. However, any patient who may be scanned with the presence of any of the above objects is not at any risk of harm by the device. Prosthetic joints are allowed if the MCG Quality Preview is acceptable.
• • EXCLUSION CRITERIA
• An individual who meets any of the following criteria will be excluded from participation in this study:
• 1. Obstructive CAD (either anatomical or physiological) defined as:
• • 1.1. ≥ 70% lesion in any major epicardial or branch vessel by CT or invasive Angiography; 1.2. ≥ 50% lesion in the Left Main (LM) vessel by CT or invasive Angiography; 1.3. or either an FFR\<0.80 or iFR or RFR \<0.89 in the obstructed vessel,
• 2. Any of the following cardiac pathologies:
• • 2.1. Epicardial spasm. 2.2. History of non-ischemic dilated or hypertrophic cardiomyopathy. 2.3. Suspected myocarditis. 2.4. Documented acute coronary syndrome (ACS) within previous 30 days. 2.5. Known left ventricular ejection fraction (LVEF) \<45% on most recent assessment (can be via ECHO), or hospitalization for Reduced ejection fraction within 180 days. (HFpEF is allowed).
• • 2.6. Currently in atrial fibrillation or atrial flutter at the time of enrollment.
• • 2.7. Complete Bundle Branch Block. 2.8. Known moderate or severe valvular disease (anything besides mild). 2.9. Known severe Left ventricular hypertrophy (LVH) as determined by Echocardiography.
• • 2.10. Dextrocardia.
• • 3. Known estimated glomerular filtration rate (eGFR) \<30 ml/min.
• • 4. Life expectancy \<3-yrs. due to non-cardiovascular comorbidity.
• • 5. Concurrent enrollment in a clinical trial in which therapeutic intervention is administered within 30 days of enrollment.
• • 6. Prior enrollment in MICRO 1.0 and/or MICRO(T) data development study.
• • 7. Pregnancy.