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Validation of Cor-IS Impedance Spectroscopy Against Ultrasound Flow-Mediated Dilation
Sponsor: Aristotle University Of Thessaloniki
Summary
This prospective observational study evaluated the Cor-IS bioelectrical impedance spectroscopy technique for the assessment of endothelial function by comparison with ultrasound-based brachial artery flow-mediated dilation (FMD). A total of 208 participants were enrolled and classified into three groups according to their cardiovascular profile: healthy controls, individuals with cardiovascular risk factors, and patients with acute myocardial infarction. Each participant underwent endothelial function assessment using both ultrasound-based FMD and the Cor-IS technique under standardized conditions. The primary objective was to evaluate the correlation and agreement between measurements obtained using Cor-IS and ultrasound-based FMD. Secondary objectives included comparing endothelial function measurements across the three study groups and evaluating their associations with selected clinical and demographic characteristics.
Official title: A Single-Center, Observational Study Evaluating the Cor-IS Impedance Spectroscopy Technique Against Ultrasound Imaging Using Flow-Mediated Dilation Protocol in Healthy Individuals and Patients With Intermediate and Severe Endothelial Dysfunction
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
208
Start Date
2021-09-01
Completion Date
2026-08-01
Last Updated
2026-10-20
Healthy Volunteers
Yes
Conditions
Interventions
Cor-IS FMD
Endothelial function was assessed using the Cor-IS bioelectrical impedance spectroscopy technique. Electrical impedance was recorded in real time using two metallic ECG electrodes placed on the left forearm. A low-amplitude alternating current (70 kHz, 0.5 mA RMS) was applied. Measurements were obtained during a standardized ischemic stimulus consisting of a 2-minute baseline period, 5 minutes of cuff-induced arterial occlusion at 50 mmHg above systolic blood pressure, followed by cuff deflation and assessment of the post-ischemic response.
Ultrasound FMD
Brachial artery flow-mediated dilation (FMD) was assessed in the right arm using a high-resolution ultrasound system (Aloka ProSound A6) with integrated e-Tracking software. Following baseline recording, a forearm cuff was inflated to 50 mmHg above systolic blood pressure for 5 minutes to induce arterial occlusion. After cuff deflation, brachial artery diameter was continuously recorded during reactive hyperemia to determine the peak vasodilatory response and calculate FMD%.
Locations (1)
Ιppokratio General Hospital of Thessaloniki
Thessaloniki, Greece