Myocardial Ischemia Clinical Trial
— MICRO2Official title:
Magnetocardiography as a Noninvasive Diagnostic Strategy for Suspected Myocardial Ischemia With No Obstructive Coronary Artery Disease
Verified date | June 2024 |
Source | Genetesis Inc. |
Contact | Zoe E Swann, PhD |
Phone | 4802868695 |
zoe.swann[@]genetesis.com | |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Not yet recruiting |
Enrollment | 135 |
Est. completion date | December 15, 2024 |
Est. primary completion date | December 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | INCLUSION CRITERIA In order to be eligible to participate in this study, an individual must meet all the following criteria: 1. = 18 years of age at the time of enrollment. 2. Willing to provide written informed consent. 3. Signs and symptoms of chest pain prompted further evaluation by a coronary angiogram within the previous 5 years. 4. Invasive CFR (via bolus thermodilution) completed within 180 days, or scheduled within 30 days, of informed consent. 4.1. CFR must be performed in the mid Left Anterior Descending (LAD) vessel. 5. 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. 5.3.2. Implanted pacemakers or cardioverter/defibrillators. 5.3.3. Implanted infusion pumps and/or neuro stimulators. 5.3.4. Note: sternotomy wires and stents are acceptable. 5.3.5. Note: Failure to meet inclusion criteria 5.3 will render the MCG scan uninterpretable. However, any patient who may be scanned with the presence of any of the above objects is not at any risk of harm by the device. Prosthetic joints are allowed if the MCG Quality Preview is acceptable. EXCLUSION CRITERIA An individual who meets any of the following criteria will be excluded from participation in this study: 1. Obstructive CAD (either anatomical or physiological) defined as: 1.1. = 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, 2. Any of the following cardiac pathologies: 2.1. 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). 2.6. Currently in atrial fibrillation or atrial flutter at the time of enrollment. 2.7. 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. 2.10. Dextrocardia. 3. Known estimated glomerular filtration rate (eGFR) <30 ml/min. 4. Life expectancy <3-yrs. due to non-cardiovascular comorbidity. 5. Concurrent enrollment in a clinical trial in which therapeutic intervention is administered within 30 days of enrollment. 6. Prior enrollment in MICRO 1.0 and/or MICRO(T) data development study. 7. Pregnancy. |
Country | Name | City | State |
---|---|---|---|
United States | The Christ Hospital | Cincinnati | Ohio |
United States | Cleveland Clinic, Cardiovascular Medicine Research | Cleveland | Ohio |
United States | Ascension St. John Hospital | Detroit | Michigan |
United States | University of Florida, Division of Cardiovascular Medicine | Gainesville | Florida |
United States | St. Luke's Health System, Cardiovascular Research | Kansas City | Missouri |
United States | Hackensack Meridian Mountainside Medical Center | Montclair | New Jersey |
United States | Mayo Clinic, Cardiovascular Research | Rochester | Minnesota |
Lead Sponsor | Collaborator |
---|---|
Genetesis Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Seattle Angina Questionnaire - 7 | For patients whose CFR was completed within 30 days of MCG scan, SAQ-7 scores may be measured and analyzed. | 30 days | |
Other | Comparison of functional vs structural CMD | Comparison of functional vs structural CMD will be analyzed (endothelial dependent vs independent). | 6 months | |
Primary | 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 | Sensitivity and specificity in determining presence of CMD (Rule In) | 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 =0.70 |
6 months | |
Secondary | Sensitivity and specificity in determining presence of CMD (Rule Out) | Patients who have confirmed absence of CMD via invasive CFR:
Sensitivity H0<0.70 Ha=0.70 Specificity H0<0.30 Ha =0.30 |
6 months | |
Secondary | ROC/AUC, sensitivity and specificity at CFR cut-offs of <2.0 and 3.0. | ROC/AUC, sensitivity and specificity for invasive CFR by thermodilution methods at CFR cut-offs of <2.0 and 3.0. | 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 Age | Age (years) | 6 months | |
Secondary | Participant Height | in meters; if known | 6 months | |
Secondary | Participant Weight | in kilograms; if known | 6 months | |
Secondary | Participant Gender at Birth | Male/Female | 6 months | |
Secondary | Index of Microvascular Resistance (IMR) | Sensitivity, Specificity, and ROC/AUC for CardioFlux will also be calculated against Index of Microvascular Resistance (IMR), defined as >25. | 6 months | |
Secondary | Comparison of bolus vs. continuous thermodilution | Comparison of bolus thermodilution (CFR-bolus) and continuous thermodilution (CFR-cont) against MCG when CFR-cont is available. | 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 |
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