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Trial record 1 of 1 for:    NCT05150054
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MCG as a Noninvasive Diagnostic Strategy for Suspected Coronary Microvascular Dysfunction (MICRO)

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ClinicalTrials.gov Identifier: NCT05150054
Recruitment Status : Enrolling by invitation
First Posted : December 8, 2021
Last Update Posted : March 10, 2022
Sponsor:
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

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Study Type : Observational
Estimated Enrollment : 150 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
Estimated Primary Completion Date : December 22, 2022
Estimated Study Completion Date : December 22, 2022

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

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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.
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT05150054


Locations
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United States, Ohio
The Christ Hospital
Cincinnati, Ohio, United States, 45219
Genetesis Facility
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Genetesis Inc.
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Responsible Party: Genetesis Inc.
ClinicalTrials.gov Identifier: NCT05150054    
Other Study ID Numbers: 1000-6
First Posted: December 8, 2021    Key Record Dates
Last Update Posted: March 10, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.:
INOCA
Magnetocardiography
CardioFlux
MCG
Coronary Microvascular Dysfunction
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases