An observational study in Endothelial Dysfunction, Acute Myocardial Infarction (AMI) and Cardiovascular Risk Factors (e.g., Hypertension), sponsored by Aristotle University Of Thessaloniki. Completed at 1 site in Greece. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-20.
Sponsored by Aristotle University Of Thessaloniki · Observational
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.
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The study population consisted of 208 prospectively enrolled participants classified into three groups according to their cardiovascular profile: healthy adult controls without known cardiovascular or metabolic disease, individuals with at least one established cardiovascular risk factor (arterial hypertension, diabetes mellitus, or dyslipidemia), and patients with confirmed acute myocardial infarction. Participants with cardiovascular risk factors were recruited from the outpatient clinics of Hippokratio General Hospital of Thessaloniki, while patients with acute myocardial infarction were enrolled following hospital admission.
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Exclusion Criteria:
Healthy adult volunteers with no history or evidence of cardiovascular or metabolic disease, as confirmed by medical history, clinical examination, and laboratory evaluation.
Diagnostic Test: Cor-IS FMD · Diagnostic Test: Ultrasound FMD
Individuals with at least one established cardiovascular risk factor, including arterial hypertension, diabetes mellitus, or dyslipidemia, recruited from the outpatient clinics of Hippokratio General Hospital of Thessaloniki.
Diagnostic Test: Cor-IS FMD · Diagnostic Test: Ultrasound FMD
Patients admitted through the emergency department with a confirmed diagnosis of acute myocardial infarction (AMI), based on clinical symptoms, cardiac biomarkers, and, when available, coronary angiography. FMD was assessed on the day of hospital discharge, typically three to six days after admission.
Diagnostic Test: Cor-IS FMD · Diagnostic Test: Ultrasound 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.
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%.
Diagnostic Performance of Cor-IS for the Detection of Endothelial Dysfunction
Diagnostic performance of the Cor-IS bioelectrical impedance spectroscopy technique for the detection of endothelial dysfunction, using ultrasound-based flow-mediated dilation (FMD) as the reference method. Diagnostic performance was evaluated using receiver operating characteristic (ROC) curve analysis, including area under the ROC curve (AUC), sensitivity, specificity, and identification of an optimal Cor-IS cut-off value.
Time frame: At baseline (Day 1 - single study visit)
Correlation and Agreement Between Cor-IS and Ultrasound-Based FMD
Correlation and agreement between endothelial function measurements obtained using the Cor-IS technique and ultrasound-based brachial artery flow-mediated dilation (FMD) were evaluated during the same study visit.
Time frame: Baseline (Day 1)
Plan to share: No
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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