NCT05150054: MICRO

MCG as a Noninvasive Diagnostic Strategy for Suspected Coronary Microvascular Dysfunction

Completed Last updated 31 August 2023

What this trial tests

trial testing CardioFlux in Coronary Microvascular Dysfunction in 93 participants. Completed in 30 July 2023.

Timeline

14 January 2022

Primary endpoint
18 July 2023

30 July 2023

Quick facts

Lead sponsor	Genetesis Inc.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	93
Start date	14 January 2022
Primary completion	18 July 2023
Estimated completion	30 July 2023
Sites	4 locations across United States

Drugs / interventions tested

• CardioFlux

Conditions studied

• Coronary Microvascular Dysfunction — all drugs for Coronary Microvascular Dysfunction →
• Ischemic Non-Obstructive Coronary Artery Disease — all drugs for Ischemic Non-Obstructive Coronary Artery Disease →

Sponsor

Genetesis Inc.

Who can join

Adults 18 to 100, any sex, with Coronary Microvascular Dysfunction or Ischemic Non-Obstructive Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Evaluation of coronary microvascular dysfunction using magnetocardiography: A new application to an old technology.
   Ashokprabhu N, Ziada K, Daher E, Cho L, et al · · 2024 · cited 8× · PMID 39108843 · DOI 10.1016/j.ahjo.2024.100424