This is the classic website, which will be retired eventually. Please visit the modernized instead.
Working… Menu
Trial record 1 of 1 for:    NCT05150054
Previous Study | Return to List | Next Study

MCG as a Noninvasive Diagnostic Strategy for Suspected Coronary Microvascular Dysfunction (MICRO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT05150054
Recruitment Status : Completed
First Posted : December 8, 2021
Last Update Posted : August 31, 2023
Information provided by (Responsible Party):
Genetesis Inc.

Brief Summary:
According to the Women's Ischemic Syndrome Evaluation database, there are approximately 3 to 4 million women and men who present with signs and symptoms that are suggestive of myocardial ischemia, however they have no obstructive coronary artery disease (INOCA). INOCA is defined as patients presenting with signs or symptoms of ischemia but no obstructive artery disease. Women are more likely than men to die from cardiovascular disease and more likely to present with no obstructive coronary artery disease. Patients who present with signs and symptoms suggestive of INOCA/MINOCA are also presenting with Coronary Microvascular Dysfunction (CMD). Coronary Microvascular Dysfunction is a dysfunction in the epicardial and/or microvascular endothelial and/or nonendothelial that limits myocardial perfusion. Today, there is no routinely offered/available noninvasive test that is used for the diagnosis of CMD, significantly hindering the ability to identify the disease in the standard of care. Magenetocardiography (MCG) has the opportunity to use its noninvasive imaging techniques to provide early management of CMD. 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 yield surface electric field potentials as measured by the electrocardiogram. Since MCG is a functional assessor of repolarization heterogeneity, it is hypothesized that MCG may be a useful frontline diagnostic 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 this population, with the goal of providing early and noninvasive insights for management of CMD. There will be a 12-month duration of the study where the investigators propose to collect MCG scans from approximately 150 patients who present to the Genetesis facility for a 15-minute CardioFlux scan appointment.

Condition or disease Intervention/treatment
Coronary Microvascular Dysfunction Ischemic Non-Obstructive Coronary Artery Disease Device: CardioFlux

Layout table for study information
Study Type : Observational
Actual Enrollment : 93 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Magnetocardiography as a Noninvasive Diagnostic Strategy for Suspected Coronary Microvascular Dysfunction
Actual Study Start Date : January 14, 2022
Actual Primary Completion Date : July 18, 2023
Actual Study Completion Date : July 30, 2023

Intervention Details:
  • Device: CardioFlux
    Not an intervention

Primary Outcome Measures :
  1. Diagnostic accuracy of CardioFlux [ Time Frame: 12 months ]
    Analyzing the diagnostic accuracy of CardioFlux in determining the presence of coronary microvascular dysfunction

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
All patients presenting with 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.

Inclusion Criteria:

  1. ≥ 18 years of age at the time of enrollment
  2. 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
  3. Willing to provide written informed consent
  4. Non-obstructive CAD defined as 0 to 49% diameter reduction of a major epicardial vessel or a FFR>0.80
  5. Scheduled for CRT
  6. No cardiac medications in the last 24 hours of an MCG-CF scan (with the exception of the patients enrolled in the data development set)

Exclusion Criteria:

  1. Patients unable to fit into device
  2. Non-ambulatory patients
  3. Patients who meet device contraindications
  4. Patients unable to lie supine for 5 minutes
  5. History of noncompliance (with medical therapy, protocol, or follow-up)
  6. History of non-ischemic dilated or hypertrophic cardiomyopathy
  7. Documented acute coronary syndrome (ACS) within previous 30 days
  8. Left ventricular ejection fraction (LVEF) <40%, New York Heart Association heart failure (NYHA HF) class III-IV, or hospitalization for Reduced ejection fraction (HFrEF) within 180 days
  9. Stroke within previous 180 days or intracranial hemorrhage at any time
  10. End-stage renal disease, on dialysis, or estimated glomerular filtration rate (eGFR) <30 ml/min.
  11. Severe valvular disease or likely to require surgery/Transcatheter aortic valve replacement (TVAR) within 3 years
  12. Life expectancy <3-yrs. due to non-cardiovascular comorbidity
  13. Enrolled in a competing clinical trial
  14. Prior intolerance to both an ACE-I and ARB
  15. If intolerant to a statin unless taking a PCSK9 as a statin replacement by their clinical provider
  16. Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05150054

Layout table for location information
United States, Michigan
Ascension St. John
Detroit, Michigan, United States, 48236
United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Genetesis Facility
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Genetesis Inc.
Layout table for additonal information
Responsible Party: Genetesis Inc. Identifier: NCT05150054    
Other Study ID Numbers: 1000-6
First Posted: December 8, 2021    Key Record Dates
Last Update Posted: August 31, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Genetesis Inc.:
Coronary Microvascular Dysfunction
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arterial Occlusive Diseases
Vascular Diseases