Subclinical AtherosclerosisAVERENCT07504679
Adipose Visceral and Epicardial Risk Evaluation
A study testing Peripheral blood sampling in people with Subclinical Atherosclerosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
Trial summary
The goal of this procedure-based interventional study without drugs or devices is to investigate the molecular mechanisms underlying metabolically unfavorable obesity and related clinical phenotypes, in order to identify non-invasive biomarkers capable of early prediction of metabolic syndrome, type 2 diabetes… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Subclinical Atherosclerosis
- What is being tested?
- Peripheral blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Outpatients attending screening or prevention programs at Fondazione Policlinico Universitario A. Gemelli IRCCS
- Ability to provide written informed consent
- Willingness to undergo:
- Additional blood collection for metabolic and inflammatory biomarker analyses
- Liver elastography (FibroScan)
Who cannot join
- Documented history of atherosclerotic cardiovascular disease, including myocardial infarction, angina pectoris, coronary angioplasty, coronary artery bypass grafting, peripheral artery disease, lower limb revascularization procedures, ischemic stroke, hemodynamically significant carotid stenosis, carotid endarterectomy or angioplasty, or aortopathy;
- Known chronic liver disease of other etiology (e.g., viral hepatitis, autoimmune liver disease, hemochromatosis, alcoholic liver disease);
- Significant alcohol consumption (>30 g/day for men, >20 g/day for women);
- Chronic systemic inflammatory diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriasis, inflammatory bowel disease, spondyloarthritis, mixed connective tissue disease, etc.);
- Active chronic infections, including HIV, active hepatitis B or C, untreated latent tuberculosis, or any other diagnosed chronic infection;
- Active or past malignancy within the last 5 years;
Show all 9Show fewer
- Current treatment with systemic anti-inflammatory drugs, immunosuppressants, or corticosteroids at pharmacological doses;
- Current pregnancy or breastfeeding;
- Any clinical or psychiatric condition that, in the investigator's judgment, could compromise participation or the validity of collected data.
About this study
The goal of this procedure-based interventional study without drugs or devices is to investigate the molecular mechanisms underlying metabolically unfavorable obesity and related clinical phenotypes, in order to identify non-invasive biomarkers capable of early prediction of metabolic syndrome, type 2 diabetes mellitus, MASLD, and cardiovascular disease in adult participants without known cardiovascular or liver disease.
The main questions it aims to answer are:
Read more
- What is the association between epicardial and visceral fat thickness and plasma levels of low-grade inflammatory biomarkers?
- How do these parameters relate to the presence of metabolic syndrome, type 2 diabetes mellitus, MASLD, and subclinical atherosclerosis?
Participants will:
- Undergo a comprehensive clinical evaluation, including demographic, anthropometric, and medical history data;
- Complete non-invasive diagnostic assessments, including 12-lead electrocardiogram, transthoracic echocardiography, liver elastography (FibroScan), and carotid Doppler ultrasound;
- Provide peripheral venous blood samples for biochemical, cellular, and molecular analyses.
- Conditions
- Subclinical Atherosclerosis
- Being tested
- Peripheral blood sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral blood samplingOther
Collection of blood specimens for biochemical, cellular, and molecular studies.
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing cardiometabolic evaluation | Experimental | Demographic data, anthropometric measures, physical examination and information about medical history, concomitant medication and variables related to inclusion criteria are collected. Peripheral venous blood sampling for collection of biological specimens to perform biochemical, cellular, and molecular analyses aimed at assessing immuno-metabolic and inflammatory parameters. Receives: Other: Peripheral blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between epicardial and visceral fat thickness and low-grade inflammatory biomarkers with cardiometabolic and hepatic outcomes
Evaluation of the relationship between epicardial and visceral adipose tissue thickness and plasma levels of low-grade inflammatory biomarkers (hs-CRP, IL-6, TNF-α) with the presence of:
- Subclinical atherosclerotic disease;
- Metabolic syndrome
- Type 2 diabetes mellitus
- Metabolic dysfunction-associated steatotic liver disease (MASLD)
Measured: Single time point at enrollment (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start1 May 2026 (estimated)
- Primary completion30 Mar 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subclinical AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liuzzo Giovanna, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07504679
- Sponsor's protocol ID
- 7919
- Acronym
- AVERE
- Status last verified
- Mar 2026
- First submitted
- 26 Mar 2026
- Last updated
- 1 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose Visceral and Epicardial Risk Evaluation
- ClinicalTrials.gov ID
- NCT07504679
- Acronym / sponsor ID
- AVERE / 7919
- Conditions
- Subclinical Atherosclerosis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 1 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this procedure-based interventional study without drugs or devices is to investigate the molecular mechanisms underlying metabolically unfavorable obesity and related clinical phenotypes, in order to identify non-invasive biomarkers capable of early prediction of metabolic syndrome, type 2 diabetes mellitus, MASLD, and cardiovascular disease in adult participants without known cardiovascular or liver disease.
The main questions it aims to answer are:
- What is the association between epicardial and visceral fat thickness and plasma levels of low-grade inflammatory biomarkers?
- How do these parameters relate to the presence of metabolic syndrome, type 2 diabetes mellitus, MASLD, and subclinical atherosclerosis?
Participants will:
- Undergo a comprehensive clinical evaluation, including demographic, anthropometric, and medical history data;
- Complete non-invasive diagnostic assessments, including 12-lead electrocardiogram, transthoracic echocardiography, liver elastography (FibroScan), and carotid Doppler ultrasound;
- Provide peripheral venous blood samples for biochemical, cellular, and molecular analyses.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing cardiometabolic evaluation | Experimental | Other: Peripheral blood samplingDemographic data, anthropometric measures, physical examination and information about medical history, concomitant medication and variables related to inclusion criteria are collected. Peripheral venous blood sampling for collection of biological specimens to perform biochemical, cellular, and molecular analyses aimed at assessing immuno-metabolic and inflammatory parameters. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥ 18 years
- Outpatients attending screening or prevention programs at Fondazione Policlinico Universitario A. Gemelli IRCCS
- Ability to provide written informed consent
- Willingness to undergo:
- Additional blood collection for metabolic and inflammatory biomarker analyses
Key exclusion criteria (9 listed)
- Documented history of atherosclerotic cardiovascular disease, including myocardial infarction, angina pectoris, coronary angioplasty, coronary artery bypass grafting, peripheral artery disease, lower limb revascularization procedures, ischemic stroke, hemodynamically significant carotid stenosis, carotid endarterectomy or angioplasty, or aortopathy;
- Known chronic liver disease of other etiology (e.g., viral hepatitis, autoimmune liver disease, hemochromatosis, alcoholic liver disease);
- Significant alcohol consumption (>30 g/day for men, >20 g/day for women);
- Chronic systemic inflammatory diseases (e.g., rheumatoid arthritis, systemic lupus erythematosus, psoriasis, inflammatory bowel disease, spondyloarthritis, mixed connective tissue disease, etc.);
- Active chronic infections, including HIV, active hepatitis B or C, untreated latent tuberculosis, or any other diagnosed chronic infection;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral blood samplingCollection of blood specimens for biochemical, cellular, and molecular studies. | Other | Patients undergoing cardiometabolic evaluation |
Primary outcome
Association between epicardial and visceral fat thickness and low-grade inflammatory biomarkers with cardiometabolic and hepatic outcomes
Time frame: Single time point at enrollment (baseline)
Evaluation of the relationship between epicardial and visceral adipose tissue thickness and plasma levels of low-grade inflammatory biomarkers (hs-CRP, IL-6, TNF-α) with the presence of: * Subclinical atherosclerotic disease; * Metabolic syndrome * Type 2 diabetes mellitus * Metabolic dysfunction-associated steatotic liver disease (MASLD)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
Related trials for Subclinical Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 4
Feasibility of Combination Therapy With Low-dose Statin and Ezetimibe in Patients With Minimal Subclinical Atherosclerosis
Atherosclerosis Cardiovascular Disease
RecruitingPhase 3
Aspirin in Subclinical Coronary Artery Disease: A Pilot Randomised Controlled Trial
Coronary Artery Disease, Subclinical Atherosclerotic Cardiovascular Disease
Not yet recruitingObservational study
Non Invasive Assessment of Subclinical Atherosclerosis and Cardiovascular Risk Using TYG Index in Lupus Nephritis
Systemic Lupus Erthematosus (SLE), Lupus Nephritis (LN)
Active, not recruitingObservational study
DETECTion of the Prevalence of Silent Atherosclerosis Across Adult Life - Phase I of REACT
Atherosclerosis, Subclinical Atherosclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Peripheral blood sampling in people with Subclinical Atherosclerosis, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association between epicardial and visceral fat thickness and low-grade inflammatory biomarkers with cardiometabolic and hepatic outcomes (time frame: Single time point at enrollment (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2026.