Endothelial DysfunctionNCT07882550
Validation of Cor-IS Impedance Spectroscopy Against Ultrasound Flow-Mediated Dilation
An observational study of Endothelial Dysfunction and Acute Myocardial Infarction (AMI), run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction, Acute Myocardial Infarction (AMI), Cardiovascular Risk Factors (e.g., Hypertension)
- What is being tested?
- Cor-IS FMD and Ultrasound FMD
- How many people
- 208 participants
- Where
- 1 siteGreece
- Study dates
- 1 Sep 2021to 1 Aug 2026
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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.
Who may be able to join
- Adult participants able to provide participation consent.
- Healthy controls: no history or evidence of cardiovascular or metabolic disease based on medical history, clinical examination, and laboratory evaluation.
- Cardiovascular risk factor group: presence of at least one established cardiovascular risk factor, including arterial hypertension, diabetes mellitus, or dyslipidemia.
- Acute myocardial infarction group: confirmed diagnosis of acute myocardial infarction based on clinical presentation and cardiac biomarkers, with coronary angiography when available.
Who cannot join
- Active cancer.
- Diagnosed psychiatric disorders.
- Pregnancy.
- Non-sinus cardiac rhythm.
- Presence of a cardiac pacemaker.
- Hemodynamic instability, defined as resting heart rate greater than 110 beats/min or systolic/diastolic blood pressure greater than 170/100 mmHg.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Endothelial Dysfunction, Acute Myocardial Infarction (AMI), Cardiovascular Risk Factors (e.g., Hypertension), Flow Mediated Dilation, Flow-mediated Dilation Evaluation of the Brachial Artery, Coronary Disease
- Being tested
- Cor-IS FMD, Ultrasound FMD
- Keywords
- Flow-Mediated Dilation, FMD, Cor-IS, Bioelectrical Impedance Spectroscopy, Endothelial Function, Brachial Artery, Endothelial dysfunction
- Medical subject headings
- Hypertension, Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cor-IS FMDDiagnostic test
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 FMDDiagnostic test
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%.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Controls | Healthy adult volunteers with no history or evidence of cardiovascular or metabolic disease, as confirmed by medical history, clinical examination, and laboratory evaluation. Receives: Diagnostic Test: Cor-IS FMD; Diagnostic Test: Ultrasound FMD | |
| Cardiovascular Risk Factors | 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. Receives: Diagnostic Test: Cor-IS FMD; Diagnostic Test: Ultrasound FMD | |
| Acute Myocardial Infarction | 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. Receives: Diagnostic Test: Cor-IS FMD; Diagnostic Test: Ultrasound FMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline (Day 1 - single study visit)
Secondary outcomes (1)
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.
Measured: Baseline (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2026
- Study start1 Sep 2021
- Primary completion1 Apr 2026
- Study completion1 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07882550
- Sponsor's protocol ID
- CORIS-FMD-STUDY
- Status last verified
- Sep 2026
- First submitted
- 29 Sep 2026
- Last updated
- 20 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No