Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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. The reference standard for diagnosis will be invasive coronary flow reserve (CFR) measured using thermodilution.
The study utilizes a magnetocardiography (MCG) scanner known as CardioFlux, complemented by cloud processing software. The scanning procedure is designed to last approximately 15 minutes per participant, encompassing 5 minutes for patient preparation, 5 minutes for the CardioFlux scan, and an additional 5 minutes for a post-scan patient survey.
The primary objective is to assess the ability of MCG, through CardioFlux, to accurately determine the presence of myocardial ischemia in comparison to the reference standard CFR. The study will provide valuable insights into the diagnostic potential of MCG and its role in CMD detection, contributing to advancements in non-invasive cardiovascular diagnostics.
The primary study outcome measures shall be the detection of myocardial ischemia with no obstructive coronary artery disease (INOCA) using MCG-CF compared to Cardiac Thermodilution derived CFR. The secondary study outcome measures shall be the MCG Questionnaire, Demographic data (age, sex, height, weight, etc.), Relevant patient medical history, EKG results (if available), and Invasive CFR/angiogram results.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Experiences with MCG | 6 months | |
| Participant Demographic Characteristics | weight (kg) | 6 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Men and women with suspected or confirmed myocardial ischemia with no obstructive coronary artery disease (INOCA).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Odayme E Quesada, MD | The Christ Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32608 | United States | ||
| Ascension St. John Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D017566 | Microvascular Angina |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Participant Demographic Characteristics |
age, sex, vital signs |
| 6 months |
| Electrocardiogram (EKG) | If participants have undergone electrocardiogram (EKG) testing, the results will be considered to provide additional insights into their cardiac electrical activity. | 6 months |
| Invasive Coronary Flow Reserve (CFR) and Angiogram Outcomes | 6 months |
| Detroit |
| Michigan |
| 48236 |
| United States |
| The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |