MCG as a Noninvasive Diagnostic Strategy for Suspected INOCA (MICRO2)

NCT06212466 | Completed

• 1 other identifier: MICRO 2.0
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 8

Brief 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.

Conditions

Ischemic Heart Disease; Coronary Microvascular Disease; Angina; Myocardial Ischemia

Keywords

Magnetocardiography; CardioFlux; Coronary Flow Reserve

Outcome Measures

Primary Outcomes (1)

• 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

  6 months

Secondary Outcomes (11)

• Sensitivity and specificity in determining presence of CMD (Rule In)

  6 months

• Sensitivity and specificity in determining presence of CMD (Rule Out)

  6 months

• ROC/AUC, sensitivity and specificity at CFR cut-offs of <2.0 and 3.0.

  6 months

• Patient-Reported Experiences with CardioFlux

  6 months

• Participant Age

  6 months

Other Outcomes (2)

• Seattle Angina Questionnaire - 7

  30 days

• Comparison of functional vs structural CMD

  6 months

Study Arms (2)

CMD Positive

Patients who have confirmed presence of CMD via invasive angiography/CFR

Device: CardioFlux

CMD Negative

Patients who have confirmed absence of CMD via invasive angiography/CFR

Device: CardioFlux

Interventions

CardioFlux DEVICE

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.

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 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.

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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:
• ≥ 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:
• 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).
• Currently in atrial fibrillation or atrial flutter at the time of enrollment.
• 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.
• 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.

Sponsors & Collaborators

• Genetesis Inc.: lead

Study Sites (8)

University of Florida, Division of Cardiovascular Medicine

Gainesville, Florida, 32610, United States

Location

Saint Elizabeth Medical Center

Edgewood, Kentucky, 41017, United States

Location

Ascension St. John Hospital

Detroit, Michigan, 48236, United States

Location

Mayo Clinic, Cardiovascular Research

Rochester, Minnesota, 55905, United States

Location

St. Luke's Health System, Cardiovascular Research

Kansas City, Missouri, 64111, United States

Location

Hackensack Meridian Mountainside Medical Center

Montclair, New Jersey, 07042, United States

Location

The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic, Cardiovascular Medicine Research

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

• Zoe E Swann, PhD

  Genetesis Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: January 18, 2024
• Study Start: June 3, 2024
• Primary Completion: April 15, 2025
• Study Completion: April 15, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)