MCG as a Noninvasive Diagnostic Strategy for Suspected INOCA (MICRO2) (NCT06212466) | Clinical Trial Compass
CompletedNot Applicable
MCG as a Noninvasive Diagnostic Strategy for Suspected INOCA (MICRO2)
United States136 participantsStarted 2024-06-03
Plain-language summary
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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. ≥ 18 years of age at the time of enrollment.
. Willing to provide written informed consent.
. Signs and symptoms of chest pain prompted further evaluation by a coronary angiogram within the previous 5 years.
. Invasive CFR (via bolus thermodilution) completed within 180 days, or scheduled within 30 days, of informed consent.
.1. CFR must be performed in the mid Left Anterior Descending (LAD) vessel.
. 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Diagnostic accuracy of CardioFlux MCG in determining the presence of CMD
.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
. Obstructive CAD (either anatomical or physiological) defined as:
.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,
. Any of the following cardiac pathologies:
.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).
.6. Currently in atrial fibrillation or atrial flutter at the time of enrollment.
.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.
.10. Dextrocardia.
. Known estimated glomerular filtration rate (eGFR) \<30 ml/min.