Correlation Between an Impedance Cardiography Test for Decompensation and the Development of Left Ventricular Replacement Fibrosis

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDermed Diagnostics, Inc.

About this trial

The purpose of this study is to evaluate the effectiveness of impedance cardiography (ICG), the HYPERGRAPH test, in detecting left ventricular decompensation in patients with aortic stenosis, compared to cardiac magnetic resonance (CMR) imaging findings. The study aims to obtain usable ICG test data on six patients with aortic stenosis who have recently undergone CMR scans with late gadolinium enhancement, and who do not have a history of myocardial infarction or cardiac amyloidosis. The hypothesis to be tested is that the HYPERGRAPH can accurately detect left ventricular decompensation associated with replacement fibrosis obtained from CMR imaging.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

• Male or female at least 18 years of age.

No prior history of myocardial infarction or cardiac amyloidosis.

Recent CMR scan with late gadolinium enhancement or scheduled for CMR scan with late gadolinium enhancement.

Moderate aortic stenosis and no replacement fibrosis OR Moderate aortic stenosis and symptoms who has replacement fibrosis OR Severe aortic stenosis with replacement fibrosis prior to aortic valve replacement.

Disqualifiers

• Under 18 years of age

Pregnant or breastfeeding women

Unable to consent

Prisoners

Trial design

Design model

Sequential

Treatments tested in this trial

  • Impedance Cardiography Upright/Supine Test

    Device

    This ICG upright/supine test is a comparison of \[dZ/dt\]max in the supine position to \[dZ/dt\]max in an upright position for assessing decompensation.

Treatment groups

6 Participants
are divided into 1 treatment group
Group A: Impedance cardiography testExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Correlation between ICG decompensation detection and replacement fibrosis measured by CMR scan

Look for a negative ICG test for decompensation correlating with a CMR scan indicating a very low extracellular volume and a positive ICG test for decompensation correlating with a CMR scan indicating a very high extracellular volume.

Time frame
The assessment for each participant will be performed immediately following the one-time ICG test and CMR scan.

Secondary outcomes

Other outcomes

Sponsors and contacts

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Dermed Diagnostics, Inc.

Lead sponsor

Northwestern University

Collaborator