Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-25 @ 1:27 AM
NCT ID:
NCT06139094
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT06139094
Study Brief:
Protocol Section:
NCT06139094