MCG as a Noninvasive Diagnostic Strategy for INOCA

Myocardial Ischemia Clinical Trial

— MICRO2  

Official title:

Magnetocardiography as a Noninvasive Diagnostic Strategy for Suspected Myocardial Ischemia With the Absence of Obstructive Coronary Artery Disease

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06212466
• Other study ID #: MICRO 2.0
• Status: Not yet recruiting
• Start date: February 26, 2024
• Est. completion date: August 31, 2024

Study information

• Verified date: January 2024
• Source: Genetesis Inc.
• Contact: Zoe E Swann, PhD
• Phone: 4802868695
• Email: zoe.swann[@]genetesis.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 coronary flow reserve (CFR) via invasive angiography as a reference standard for diagnosis.

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 INOCA and 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 study readers. Except for the introduction of the MCG scan, there will be no other alteration to the patient standard of care.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 135
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Gender: All
• Age group: 18 Years and older

Eligibility

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 by CT or Angiography
• or a FFR>0.80 or iFR or RFR >0.89
• Completed invasive CFR/angiogram (within 180 days of informed consent)
• Successfully passing CardioFlux MCG Quality Preview prior to MCG study scan

Exclusion Criteria:

• Patients unable to fit into device.
• Patients who meet device contraindications. The MCG signal is not able to be interpreted in patients with the following: Presence of ferromagnetic metal above the costal margin of the rib cage; Implanted pacemakers or cardioverter/defibrillators; Implanted infusion pumps and/or neuro stimulators (NOTE: sternotomy wires and stents are acceptable)
• Patients unable to lie supine for 5 minutes.
• Prior enrollment in MICRO 1.0 and/or MICRO(T) data development study.
• History of non-ischemic dilated or hypertrophic cardiomyopathy
• Documented acute coronary syndrome (ACS) within previous 30 days
• Known left ventricular ejection fraction (LVEF) <45%, 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 within previous 180 days of enrollment
• Known estimated glomerular filtration rate (eGFR) <30 ml/min.
• Known moderate or severe valvular disease (anything besides mild)
• 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.
• Pregnancy
• Dextrocardia

Related Conditions & MeSH terms

• Angina
• Coronary Artery Disease
• Coronary Microvascular Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Microvascular Angina
• Myocardial Ischemia

Intervention

Device:
• CardioFlux
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Genetesis Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of Myocardial Ischemia in the Absence of Obstructive Coronary Artery Disease (INOCA)	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 <2.0 for Doppler wire method and <2.5 for thermodilution method.	6 months
Secondary	Sensitivity and specificity of CMD Detection	Sensitivity and specificity of CardioFlux MCG in determining the presence of CMD with ground truth defined as an invasive CFR <2.0 for Doppler wire method and <2.5 for thermodilution method as determined by a positive MCG scan output.	6 months
Secondary	CMD Diagnostic accuracy (ROC/AUC)	CardioFlux MCG diagnostic accuracy (ROC/AUC) results will be calculated at the following invasive CFR cut-offs: CFR < 1.7 for Doppler wire and <2.2 for thermodilution; CFR < 2.5 for Doppler wire and <3.0 for thermodilution	6 months
Secondary	Sensitivity, Specificity, and ROC/AUC calculated against Index of Microvascular Resistance (IMR)	Sensitivity, Specificity, and ROC/AUC for CardioFlux will also be calculated against Index of Microvascular Resistance (IMR) when available.	6 months
Secondary	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.	6 months
Secondary	Participant Weight	Weight (kg)	6 months
Secondary	Participant Age	Age (years)	6 months
Secondary	Participant Heart Rate	in bpm; at time of MCG scan	6 months
Secondary	Participant Blood pressure	in mmHg; at time of MCG scan	6 months
Secondary	Participant Respiration Rate	in bpm; at time of MCG scan	6 months
Secondary	Participant Pulse Ox	in %; at time of MCG scan	6 months
Secondary	Participant Height	in meters; at time of MCG scan	6 months
Secondary	Participant Weight	in kilograms; at time of MCG scan	6 months
Secondary	Participant Sex	Male/Female	6 months
Secondary	Invasive Coronary Flow Reserve (CFR)	To determine the presence of CMD, if available	6 months
Secondary	Diagnosis of CMD via Angiogram, if available	To determine the presence of CMD, defined as either: Endothelial Independent Microvascular Dysfunction; Endothelial Dependent Microvascular Dysfunction / Microvascular Spasm; Coronary Vasospasm; None; or Other	6 months
Secondary	Number of Adverse Events	Safety will be monitored by the reporting of adverse events (related and non-related to the device) throughout the trial.	6 months
Secondary	Inter-reader reliability	Inter-reader variability during MCG scan analysis	6 months