Ischemic Heart DiseaseMICRO2NCT06212466
MCG as a Noninvasive Diagnostic Strategy for Suspected INOCA (MICRO2)
An observational study of Ischemic Heart Disease and Coronary Microvascular Disease, run by Genetesis Inc. at 8 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease, Coronary Microvascular Disease, Angina
- What is being tested?
- CardioFlux
- Type of treatment
- Medical device
- How many people
- 136 participants
- Where
- 8 sitesUnited States
- Study dates
- 3 Jun 2024to 15 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Men and women aged 18 years and older with chronic/stable angina and no obstructive coronary artery disease (suspected INOCA) with completed invasive CFR measurement within 180 days or are scheduled to undergo invasive angiography with CFR assessment by bolus thermodilution within 30 days of informed consent at an enrolling clinical trial center.
Who may be able to join
- In order to be eligible to participate in this study, an individual must meet all the following 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.
- 4.1. 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.
- 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.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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,
- 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.
Show all 13Show fewer
- 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.
- Known estimated glomerular filtration rate (eGFR) <30 ml/min.
- Life expectancy <3-yrs. due to non-cardiovascular comorbidity.
- Concurrent enrollment in a clinical trial in which therapeutic intervention is administered within 30 days of enrollment.
- Prior enrollment in MICRO 1.0 and/or MICRO(T) data development study.
- Pregnancy.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
The Christ Hospital
Cincinnati, Ohio, 45219
Cleveland Clinic, Cardiovascular Medicine Research
Cleveland, Ohio, 44195
Ascension St. John Hospital
Detroit, Michigan, 48236
Saint Elizabeth Medical Center
Edgewood, Kentucky, 41017
University of Florida, Division of Cardiovascular Medicine
Gainesville, Florida, 32610
St. Luke's Health System, Cardiovascular Research
Kansas City, Missouri, 64111
Hackensack Meridian Mountainside Medical Center
Montclair, New Jersey, 07042
Mayo Clinic, Cardiovascular Research
Rochester, Minnesota, 55905
About this study
Official title: Magnetocardiography as a Noninvasive Diagnostic Strategy for Suspected Myocardial Ischemia With No Obstructive Coronary Artery Disease
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.
Read the detailed description
Magnetocardiography (MCG) is a noninvasive imaging modality that has been extensively studied over the past several decades as a diagnostic imaging solution for various forms of cardiovascular disease. MCG measures the magnetic field that arises from the electrical activity of the heart's pacemaker activity, the very same activity which yields surface electric field potentials as measured by the electrocardiogram. Unlike electrocardiographic signals, however, MCG signals are undistorted by conductive tissue noise, and are highly sensitive to ischemic injury and vortex currents missed by the same electrocardiographic measurements. Accordingly, numerous clinical trials suggest the usefulness of MCG for the evaluation of ischemia in patients with suspected acute coronary syndrome.
There is a growing body of evidence demonstrating the usefulness of MCG in the detection of myocardial ischemia, both in patients with symptoms of ACS, and in patients with stable angina. Since MCG is a functional assessor of depolarization and repolarization heterogeneity, it is hypothesized that MCG may be a useful frontline diagnostic modality to identify CMD in patients who would otherwise have normal coronary CT angiograms and/or stress tests. The proposed study intends to study the diagnostic accuracy of MCG in patients with suspected INOCA.
This demonstrates a significant unmet clinical need in the assessment of patients, and especially women, with INOCA. The current standard of care for these patients is resource/time intensive and associated with a significant rate of non-diagnostic clinical data requiring expensive and invasive evaluation for safe patient management. Magnetocardiography offers the potential for rapid, safe, noninvasive, non-radiologic assessment of the INOCA population, and may lead to earlier treatment strategies for CMD patients.
From the participating clinical sites, patients age ≥18 years who presented with chest pain or exertional dyspnea concerning for myocardial ischemia with no obstructive epicardial CAD on invasive or computed tomographic coronary angiography will be screened and subsequently enrolled when meeting criteria. This is a prospective observational study used for clinical data collection for the clinical validation testing of the CardioFlux MCG system. There will be no intervention introduced by the study device. The interpretation of the CardioFlux MCG data made by the study reader(s) will not be known to the patient's treating physician. Similarly, the patient's coronary physiology data, diagnosis, or interventions made by the patient's treating physician in following the standard of care will not be known to any of the scan readers. Except for the introduction of the MCG scan, there will be no other alteration to the patient standard of care.
- Being tested
- CardioFlux
- Keywords
- Magnetocardiography, CardioFlux, Coronary Flow Reserve
- Medical subject headings
- Myocardial Ischemia, Microvascular Angina, Angina Pectoris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioFluxDevice
The device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with a cloud processing software for the acquisition, display, and analysis of magnetic fields generated by cardiac electrical activity.
| Study group | Role | What they receive |
|---|---|---|
| CMD Positive | Patients who have confirmed presence of CMD via invasive angiography/CFR Receives: Device: CardioFlux | |
| CMD Negative | Patients who have confirmed absence of CMD via invasive angiography/CFR Receives: Device: CardioFlux |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic accuracy of CardioFlux MCG in determining the presence of CMD
Diagnostic accuracy of CardioFlux MCG in determining the presence of coronary microvascular dysfunction, as measured by AUC with ground truth defined as an invasive CFR <2.5 for bolus thermodilution method.
H0: AUC<0.55 Ha: AUC≥0.55
Measured: 6 months
Secondary outcomes (11)
Sensitivity and specificity in determining presence of CMD (Rule In)
Patients who have confirmed presence of CMD via invasive CFR: Sensitivity and specificity of CardioFlux MCG in determining the presence of CMD with the gold standard defined as an invasive CFR <2.5 for thermodilution method as determined by a positive MCG scan output as defined by a Magnetic Dispersion Dynamics (MDD) score less than 41 fT/ms.
Sensitivity
- H0<0.30
- Ha≥0.30
Specificity
- H0<0.70
- Ha ≥0.70
Measured: 6 months
Sensitivity and specificity in determining presence of CMD (Rule Out)
Patients who have confirmed absence of CMD via invasive CFR:
Sensitivity
- H0<0.70
- Ha≥0.70
Specificity
- H0<0.30
- Ha ≥0.30
Measured: 6 months
ROC/AUC, sensitivity and specificity at CFR cut-offs of <2.0 and 3.0.
ROC/AUC, sensitivity and specificity for invasive CFR by thermodilution methods at CFR cut-offs of <2.0 and 3.0.
Measured: 6 months
Patient-Reported Experiences with CardioFlux
Self-reported questionnaire (5 questions scored 1 (very dissatisfied) to 5 (very satisfied) with a minimum score of 5 and a maximum score of 25.
Measured: 6 months
Participant Age
Age (years)
Measured: 6 months
Participant Height
in meters; if known
Measured: 6 months
Participant Weight
in kilograms; if known
Measured: 6 months
Participant Gender at Birth
Male/Female
Measured: 6 months
Index of Microvascular Resistance (IMR)
Sensitivity, Specificity, and ROC/AUC for CardioFlux will also be calculated against Index of Microvascular Resistance (IMR), defined as >25.
Measured: 6 months
Comparison of bolus vs. continuous thermodilution
Comparison of bolus thermodilution (CFR-bolus) and continuous thermodilution (CFR-cont) against MCG when CFR-cont is available.
Measured: 6 months
Number of Adverse Events
Safety will be monitored by the reporting of adverse events (related and non-related to the device) throughout the trial.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2024
- Study start3 Jun 2024
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Genetesis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zoe E Swann, PhD, Study director, Genetesis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06212466
- Sponsor's protocol ID
- MICRO 2.0
- Acronym
- MICRO2
- Status last verified
- Jul 2025
- First submitted
- 29 Nov 2023
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetocardiography as a Noninvasive Diagnostic Strategy for Suspected Myocardial Ischemia With No Obstructive Coronary Artery Disease
- ClinicalTrials.gov ID
- NCT06212466
- Acronym / sponsor ID
- MICRO2 / MICRO 2.0
- Keywords
- Magnetocardiography, CardioFlux, Coronary Flow Reserve
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- Genetesis Inc.Industry (pharma, biotech, devices)
- Study start
- 3 Jun 2024 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 18 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Magnetocardiography (MCG) is a noninvasive imaging modality that has been extensively studied over the past several decades as a diagnostic imaging solution for various forms of cardiovascular disease. MCG measures the magnetic field that arises from the electrical activity of the heart's pacemaker activity, the very same activity which yields surface electric field potentials as measured by the electrocardiogram. Unlike electrocardiographic signals, however, MCG signals are undistorted by conductive tissue noise, and are highly sensitive to ischemic injury and vortex currents missed by the same electrocardiographic measurements. Accordingly, numerous clinical trials suggest the usefulness of MCG for the evaluation of ischemia in patients with suspected acute coronary syndrome.
There is a growing body of evidence demonstrating the usefulness of MCG in the detection of myocardial ischemia, both in patients with symptoms of ACS, and in patients with stable angina. Since MCG is a functional assessor of depolarization and repolarization heterogeneity, it is hypothesized that MCG may be a useful frontline diagnostic modality to identify CMD in patients who would otherwise have normal coronary CT angiograms and/or stress tests. The proposed study intends to study the diagnostic accuracy of MCG in patients with suspected INOCA.
This demonstrates a significant unmet clinical need in the assessment of patients, and especially women, with INOCA. The current standard of care for these patients is resource/time intensive and associated with a significant rate of non-diagnostic clinical data requiring expensive and invasive evaluation for safe patient management. Magnetocardiography offers the potential for rapid, safe, noninvasive, non-radiologic assessment of the INOCA population, and may lead to earlier treatment strategies for CMD patients.
From the participating clinical sites, patients age ≥18 years who presented with chest pain or exertional dyspnea concerning for myocardial ischemia with no obstructive epicardial CAD on invasive or computed tomographic coronary angiography will be screened and subsequently enrolled when meeting criteria. This is a prospective observational study used for clinical data collection for the clinical validation testing of the CardioFlux MCG system. There will be no intervention introduced by the study device. The interpretation of the CardioFlux MCG data made by the study reader(s) will not be known to the patient's treating physician. Similarly, the patient's coronary physiology data, diagnosis, or interventions made by the patient's treating physician in following the standard of care will not be known to any of the scan readers. Except for the introduction of the MCG scan, there will be no other alteration to the patient standard of care.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMD Positive | – | Device: CardioFluxPatients who have confirmed presence of CMD via invasive angiography/CFR |
| CMD Negative | – | Device: CardioFluxPatients who have confirmed absence of CMD via invasive angiography/CFR |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Men and women aged 18 years and older with chronic/stable angina and no obstructive coronary artery disease (suspected INOCA) with completed invasive CFR measurement within 180 days or are scheduled to undergo invasive angiography with CFR assessment by bolus thermodilution within 30 days of informed consent at an enrolling clinical trial center.
Key inclusion criteria (8 listed)
- In order to be eligible to participate in this study, an individual must meet all the following 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.
Key exclusion criteria (13 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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,
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioFluxThe device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with a cloud processing software for the acquisition, display, and analysis of magnetic fields generated by cardiac electrical activity. | Device | CMD Negative, CMD Positive |
Primary outcome
Diagnostic accuracy of CardioFlux MCG in determining the presence of CMD
Time frame: 6 months
Diagnostic accuracy of CardioFlux MCG in determining the presence of coronary microvascular dysfunction, as measured by AUC with ground truth defined as an invasive CFR <2.5 for bolus thermodilution method. H0: AUC<0.55 Ha: AUC≥0.55
11 secondary outcomes
Sensitivity and specificity in determining presence of CMD (Rule In)
Time frame: 6 months
Sensitivity and specificity in determining presence of CMD (Rule Out)
Time frame: 6 months
ROC/AUC, sensitivity and specificity at CFR cut-offs of <2.0 and 3.0.
Time frame: 6 months
Patient-Reported Experiences with CardioFlux
Time frame: 6 months
Participant Age
Time frame: 6 months
Participant Height
Time frame: 6 months
Participant Weight
Time frame: 6 months
Participant Gender at Birth
Time frame: 6 months
Index of Microvascular Resistance (IMR)
Time frame: 6 months
Comparison of bolus vs. continuous thermodilution
Time frame: 6 months
Number of Adverse Events
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zoe E Swann, PhD study director
Genetesis Inc.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Heart Disease and Coronary Microvascular Disease, run by Genetesis Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic accuracy of CardioFlux MCG in determining the presence of CMD (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025; AzTrials last refreshed its copy on 2 Nov 2026.