MCG As a Noninvasive Diagnostic Strategy for Suspected INOCA (MICRO2)
- Conditions
- Myocardial IschemiaIschemic Heart DiseaseAnginaCoronary Microvascular Disease
- Interventions
- Device: CardioFlux
- Registration Number
- NCT06212466
- Lead Sponsor
- Genetesis Inc.
- 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.
- Detailed 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 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 scan readers. Except for the introduction of the MCG scan, there will be no other alteration to the patient standard of care.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 135
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description CMD Negative CardioFlux Patients who have confirmed absence of CMD via invasive angiography/CFR CMD Positive CardioFlux Patients who have confirmed presence of CMD via invasive angiography/CFR
- Primary Outcome Measures
Name Time Method Diagnostic accuracy of CardioFlux MCG in determining the presence of CMD 6 months 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
- Secondary Outcome Measures
Name Time Method Participant Age 6 months Age (years)
Sensitivity and specificity in determining presence of CMD (Rule In) 6 months Patients who have confirmed presence of CMD via invasive CFR: Sensitivity and specificity of CardioFlux MCG in determining the presence of CMD with the gold standard defined as an invasive CFR \<2.5 for thermodilution method as determined by a positive MCG scan output as defined by a Magnetic Dispersion Dynamics (MDD) score less than 41 fT/ms.
Sensitivity
* H0\<0.30
* Ha≥0.30
Specificity
* H0\<0.70
* Ha ≥0.70Participant Height 6 months in meters; if known
Sensitivity and specificity in determining presence of CMD (Rule Out) 6 months Patients who have confirmed absence of CMD via invasive CFR:
Sensitivity
* H0\<0.70
* Ha≥0.70
Specificity
* H0\<0.30
* Ha ≥0.30ROC/AUC, sensitivity and specificity at CFR cut-offs of <2.0 and 3.0. 6 months ROC/AUC, sensitivity and specificity for invasive CFR by thermodilution methods at CFR cut-offs of \<2.0 and 3.0.
Patient-Reported Experiences with CardioFlux 6 months 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.
Participant Weight 6 months in kilograms; if known
Participant Gender at Birth 6 months Male/Female
Index of Microvascular Resistance (IMR) 6 months Sensitivity, Specificity, and ROC/AUC for CardioFlux will also be calculated against Index of Microvascular Resistance (IMR), defined as \>25.
Comparison of bolus vs. continuous thermodilution 6 months Comparison of bolus thermodilution (CFR-bolus) and continuous thermodilution (CFR-cont) against MCG when CFR-cont is available.
Number of Adverse Events 6 months Safety will be monitored by the reporting of adverse events (related and non-related to the device) throughout the trial.
Trial Locations
- Locations (8)
Saint Elizabeth Medical Center
🇺🇸Saint Elizabeth Medical Center, Kentucky, United States
University of Florida, Division of Cardiovascular Medicine
🇺🇸Gainesville, Florida, United States
Ascension St. John Hospital
🇺🇸Detroit, Michigan, United States
Mayo Clinic, Cardiovascular Research
🇺🇸Rochester, Minnesota, United States
St. Luke's Health System, Cardiovascular Research
🇺🇸Kansas City, Missouri, United States
Hackensack Meridian Mountainside Medical Center
🇺🇸Montclair, New Jersey, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic, Cardiovascular Medicine Research
🇺🇸Cleveland, Ohio, United States