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NCT05150054 · ClinicalTrials.gov registry record
MCG as a Noninvasive Diagnostic Strategy for Suspected Coronary Microvascular Dysfunction
A clinical trial, sponsored by Genetesis.
- Completed
- Registry status
- 93
- Enrollment target
NCT05150054: Completed study, sponsored by Genetesis.
NCT05150054 is a clinical trial that has completed, run by Genetesis. The registered enrollment target is 93 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05150054 has completed, sponsored by Genetesis.
- COMPLETED
- Registry status
- 93 participants
- Enrollment target
Study 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 t
Primary Outcome
Analyzing the diagnostic accuracy of CardioFlux in determining the presence of coronary microvascular dysfunction
Interventions
- DEVICE CardioFlux
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 93 participants |
| Start Date | 2022-01-14 |
| Est. Completion | 2023-07-30 |
What the finished NCT05150054 record still lists
NCT05150054 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 93 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which CardioFlux is the first listed.
NCT05150054 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05150054 about?
NCT05150054 is a clinical study titled "MCG as a Noninvasive Diagnostic Strategy for Suspected Coronary Microvascular Dysfunction". 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 presenti...
What is the current status of trial NCT05150054?
This trial is currently completed. The enrollment target is 93 participants. The study started on 2022-01-14. Estimated completion is 2023-07-30.
What interventions are being tested in trial NCT05150054?
The interventions under investigation include: CardioFlux (DEVICE).
Who is sponsoring clinical trial NCT05150054?
This trial is sponsored by Genetesis, which has 9 total clinical trials registered on ClinicalTrials.gov.
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