MCG as a Noninvasive Diagnostic Strategy for Suspected Coronary Microvascular Dysfunction

NCT05150054 | Completed FDA Device

• 1 other identifier: 1000-6
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Coronary Microvascular Dysfunction; Ischemic Non-Obstructive Coronary Artery Disease

Keywords

INOCA; Magnetocardiography; CardioFlux; MCG; Coronary Microvascular Dysfunction

Outcome Measures

Primary Outcomes (1)

• Diagnostic accuracy of CardioFlux

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

  12 months

Interventions

CardioFlux DEVICE

Not an intervention

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients presenting with 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.

You may qualify if:

• ≥ 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Genetesis Inc.: lead

Study Sites (4)

Ascension St. John

Detroit, Michigan, 48236, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Genetesis Facility

Mason, Ohio, 45040, United States

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2021
• First Posted: December 8, 2021
• Study Start: January 14, 2022
• Primary Completion: July 18, 2023
• Study Completion: July 30, 2023
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)