MCG as a Noninvasive Diagnostic Strategy for Suspected Coronary Microvascular Dysfunction

According to the Women's Ischemic Syndrome Evaluation database, there are approximately 3 to 4 million women and men who present with signs and symptoms that are suggestive of myocardial ischemia, however they have no obstructive coronary artery disease (INOCA). INOCA is defined as patients presenting with signs or symptoms of ischemia but no obstructive artery disease. Women are more likely than men to die from cardiovascular disease and more likely to present with no obstructive coronary artery disease. Patients who present with signs and symptoms suggestive of INOCA/MINOCA are also presenting with Coronary Microvascular Dysfunction (CMD). Coronary Microvascular Dysfunction is a dysfunction in the epicardial and/or microvascular endothelial and/or nonendothelial that limits myocardial perfusion. Today, there is no routinely offered/available noninvasive test that is used for the diagnosis of CMD, significantly hindering the ability to identify the disease in the standard of care. Magenetocardiography (MCG) has the opportunity to use its noninvasive imaging techniques to provide early management of CMD. 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 yield surface electric field potentials as measured by the electrocardiogram. Since MCG is a functional assessor of repolarization heterogeneity, it is hypothesized that MCG may be a useful frontline diagnostic 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 this population, with the goal of providing early and noninvasive insights for management of CMD. There will be a 12-month duration of the study where the investigators propose to collect MCG scans from approximately 150 patients who present to the Genetesis facility for a 15-minute CardioFlux scan appointment.

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Key information

Conditions

Coronary Microvascular Dysfunction Ischemic Non-Obstructive Coronary Artery Disease

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ascension St. John, Detroit, Michigan, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

≥ 18 years of age at the time of enrollment
Signs and symptoms of chest pain that prompted further evaluation by either a heart angiogram or a scan of the heart (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 a FFR>0.80
Scheduled for CRT
No cardiac medications in the last 24 hours of an MCG-CF scan (with the exception of the patients enrolled in the data development set)

Exclusion criteria

Patients unable to fit into device
Non-ambulatory patients
Patients who meet device contraindications
Patients unable to lie supine for 5 minutes
History of noncompliance (with medical therapy, protocol, or follow-up)
History of non-ischemic dilated or hypertrophic cardiomyopathy
Documented acute coronary syndrome (ACS) within previous 30 days
Left ventricular ejection fraction (LVEF) <40%, New York Heart Association heart failure (NYHA HF) class III-IV, or hospitalization for Reduced ejection fraction (HFrEF) within 180 days
Stroke within previous 180 days or intracranial hemorrhage at any time
End-stage renal disease, on dialysis, or estimated glomerular filtration rate (eGFR) <30 ml/min.
Severe valvular disease or likely to require surgery/Transcatheter aortic valve replacement (TVAR) within 3 years
Life expectancy <3-yrs. due to non-cardiovascular comorbidity
Enrolled in a competing clinical trial
Prior intolerance to both an ACE-I and ARB
If intolerant to a statin unless taking a PCSK9 as a statin replacement by their clinical provider
Pregnancy

Treatment and study plan

CardioFlux

Device

Not an intervention

Primary outcomes

Diagnostic accuracy of CardioFlux

Time frame: 12 months

Analyzing the diagnostic accuracy of CardioFlux in determining the presence of coronary microvascular dysfunction

Sponsors and collaborators

Lead sponsor

Genetesis Inc.

Industry

Registry information

Official study title

Magnetocardiography as a Noninvasive Diagnostic Strategy for Suspected Coronary Microvascular Dysfunction

Acronym: MICRO

Important dates

Study start: 2022
Primary completion: 2023
Study completion: 2023
First posted: Dec 8, 2021
Registry last updated: Aug 31, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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