MCG for Suspected INOCA Confirmed by Thermodilution-Derived CFR

NCT06139094 | Completed FDA Device

• 1 other identifier: MICRO(T)
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 4

Brief Summary

This study will be an observational registry to investigate the ability of magnetocardiography (MCG) in determining the presence of myocardial ischemia with the absence of obstructive coronary artery disease, by using an invasive reference standard coronary flow reserve (CFR) measured using thermodilution for diagnosis. The device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with cloud processing software. A CardioFlux scan appointment shall last approximately 15 minutes in duration and include a patient questionnaire following the scan.

Conditions

Ischemic Heart Disease; Coronary Microvascular Disease; Angina

Keywords

Magnetocardiography; CFR via Thermodilution; CardioFlux

Outcome Measures

Primary Outcomes (1)

• Detection of Myocardial Ischemia in the Absence of Obstructive Coronary Artery Disease (INOCA)

  This observational registry study focuses on investigating the efficacy of magnetocardiography (MCG) in detecting myocardial ischemia secondary to coronary microvascular dysfunction (CMD) in the absence of obstructive coronary artery disease.

  6 months

Secondary Outcomes (5)

• Patient-Reported Experiences with MCG

  6 months

• Participant Demographic Characteristics

  6 months

• Participant Demographic Characteristics

  6 months

• Electrocardiogram (EKG)

  6 months

• Invasive Coronary Flow Reserve (CFR) and Angiogram Outcomes

  6 months

Study Arms (2)

CMD negative

Participants in this group exhibit no signs of Coronary Microvascular Disease (CMD), as evidenced by a CFR measurement equal to or greater than 2.5. This group serves as the comparative reference, representing individuals without CMD-related myocardial ischemia.

Device: CardioFlux Magnetocardiography

CMD positive

This group comprises participants demonstrating signs of Coronary Microvascular Disease (CMD), defined by a coronary flow reserve (CFR) measurement of less than 2.5. Participants in this category are experiencing myocardial ischemia without significant blockages in their coronary arteries.

Device: CardioFlux Magnetocardiography

Interventions

CardioFlux Magnetocardiography DEVICE

The device is a magnetocardiography (MCG) scanner named CardioFlux, which is paired with a cloud processing software. CardioFlux devices are owned by Genetesis and are currently cleared for the acquisition, display, and analysis of magnetic fields generated by cardiac electrical activity (K182571, FDA clearance letter available for download online)

CMD negative; CMD positive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Men and women with suspected or confirmed myocardial ischemia with no obstructive coronary artery disease (INOCA).

You may qualify if:

• ≥ 18 years of age at the time of enrollment.
• Signs and symptoms of coronary ischemia that prompted further evaluation by either invasive coronary angiography or 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 FFR\>0.80 (or non-hyperemic equivalent of iFR or RFR \>0.89)
• Completed invasive CFR via thermodilution method within 6 months of informed consent.
• Successfully passing CardioFlux's MCG ""Quality Preview" prior to MCG study scan.

You may not qualify if:

• Patients unable to fit into the CardioFlux device.
• Patients who meet device contraindications (as specified in section 1.4 of the protocol) NOTE: Sternotomy wires and stents are typically acceptable.
• Patients unable to lie supine for 5 minutes.
• History of non-ischemic dilated or hypertrophic cardiomyopathy.
• Documented acute coronary syndrome (ACS) within the previous 30 days.
• Known left ventricular ejection fraction (LVEF) \<45%, or hospitalization for Reduced ejection fraction within 180 days. (HFpEF is permitted).
• Currently in atrial fibrillation or atrial flutter at the time of enrollment.
• Estimated glomerular filtration rate (eGFR) \<30 ml/min.
• Moderate or severe valvular disease (including aortic stenosis or insufficiency).
• Life expectancy \<1-yrs. due to non-cardiovascular comorbidity.
• Concurrent enrollment in a clinical trial in which therapeutic intervention is administered within 30 days of enrollment.
• Pregnancy.
• Dextrocardia.
• History of Left or Right Bundle Branch Block within 6 months of enrollment.

Sponsors & Collaborators

• Genetesis Inc.: lead

Study Sites (4)

University of Florida

Gainesville, Florida, 32608, United States

Location

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Myocardial Ischemia; Microvascular Angina; Angina Pectoris

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Odayme E Quesada, MD

  The Christ Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: OTHER
• Target Duration: 1 Day
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2023
• First Posted: November 18, 2023
• Study Start: December 20, 2023
• Primary Completion: May 13, 2024
• Study Completion: May 13, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)