An observational study in Atherosclerosis and Calcific Aortic Stenosis with and Without Diabetes, sponsored by IRCCS SYNLAB SDN. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by IRCCS SYNLAB SDN · Observational
Among 81 studies in Atherosclerosis with a site in Italy — 12 open to participants now, 22 under way, 10 of them phase 3. Atherosclerosis · Italy.
Among the 81 studies in Atherosclerosis with a site in Italy, this one is the 29th largest by planned enrollment of the 29 observational ones that give a count, is one of 2 that started in 2023, is one of 30 observational ones, reaches primary completion later than 3 of the 21 other live ones, and was the 69th registered.
1,517 studies on the registry are indexed under Atherosclerosis; 224 are open to participants now.
Browse Atherosclerosis studies →12 of the 81 studies in Atherosclerosis with a site in Italy are open now. Recruiting first, the newest first:
Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi) · Sites in Italy, France, Netherlands and 1 more country
Ages 12+
Fondazione Ricerca e Innovazione Cardiovascolare ETS · Sites in Italy
I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio · Sites in Italy
Ages 40–70 · Healthy volunteers
Eli Lilly and Company · Sites in Italy, United States, Argentina and 25 more countries
Ages 18+
AstraZeneca · Sites in Italy, United States, Argentina and 33 more countries
Ages 18+
A study can be open while its sites in Italy have not opened yet or have stopped. Only those recruiting at a site in Italy →
Of the 161 Atherosclerosis studies recruiting now, 84 (52%) set no upper age limit and 33 (20%) stop at 75 or younger; 16 take children under 18; 33 take healthy volunteers.
This study: 18 Years and older · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
81 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 9 · Phase 3 20 · Phase 4 6
First in 1996; this study’s year is marked. 2 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 3 is below the median of 250 across 527 observational studies indexed under Atherosclerosis.
Median enrollment 423 across the 51 interventional studies, 312 across the 29 observational. Of the 43 that completed or were terminated, 15 (35%) have results posted.
This tab as a report to print or save as PDF → With an account.
33 of 81 have an industry lead sponsor. The 10 most frequent:
IRCCS SYNLAB SDN is the lead sponsor of 13 studies on the registry; 7 are open to participants now.
IRCCS SYNLAB SDN has 1 study filed under Atherosclerosis — fewer than ten, so there is no comparison to draw.
5 of the studies in Atherosclerosis with a site in Italy that are under way reach primary completion within a year, 2 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05202509Phase 3NewAmsterdam PharmaCardiovascular Outcome Study to Evaluate the Effect of Obicetrapib in Patients With Cardiovascular Disease | 2026-11 |
| NCT05030428Phase 3Novartis PharmaceuticalsStudy of Inclisiran to Prevent Cardiovascular (CV) Events in Participants With Established Cardiovascular Disease | 2027-05-10 |
| NCT06230406IRCCS Policlinico S. DonatoT-Mem GEne in Atherosclerosis | 2026-12 |
| NCT07352111I.R.C.C.S Ospedale Galeazzi-Sant'AmbrogioHigh-risk Coronary Atherosclerosis in Subjects With Family History of Myocardial Infarction | 2026-12-31 |
| NCT07447648Fondazione SISA (Societa Italiana per lo Studio della Arteriosclerosi)Assessing the Impact of Intensification of Lipid Lowering Therapy With Guidelines-based Evinacumab Administration on Coronary Plaque Volumes Measured by Coronary Computed Tomography Angiography (CCTA) in Patients With Homozygous Familial Hypercholesterolemia (HoFH) | 2027-09 |
Add all 5 to your calendar (.ics) → With an account.
Among the 81 studies in Atherosclerosis with a site in Italy, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The project aims to shed light on the role of Sirtuins, enzymes belonging to the third class of histone deacetylases (class III) involved in epigenetic modifications (deacetylation), focusing mainly on Sirtuin 6 (SIRT6), as a regulator of atherosclerosis and severe aortic valve stenosis through molecular-based and epigenetic studies in human VSMC cells.
The study plans to recruit 100 patients admitted to AOU Federico II Cardiac Surgery in Naples subject to surgical procedure with atherosclerosis and calcific aortic stenosis with and without diabetes over a 36-month period. Patients without atherosclerosis or aortic valve stenosis will be considered as a control population and where possible included in a statistical design paired for age and sex with the study population
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: lncRNA signature analyses
Diagnostic Test: lncRNA signature analyses
Diagnostic Test: lncRNA signature analyses
Specific validation experiments will be performed by Real-Time PCR (C-reactive protein), Western Blot, flow cytometry and microscopy
To evaluate by analysis of data obtained from NGS techniques whether and which proteins belonging to the Sirtuin family may be deregulated in patients with atherosclerosis or calcific aortic stenosis
Time frame: 36 months
To evaluate the experimental results achieved in the clinical-diagnostic context
Time frame: 36 months
Plan to share: No
No publications or documents are linked to this record.
Started Oct 2023 (actual). Primary completion is estimated for Oct 2025, 24 months after the start.
Of 144 non-industry observational studies under Atherosclerosis, half reached primary completion within 84 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 158. This study's planned 24 months is below that.
Counting every sponsor, half of 169 studies reached it within 62 months; a quarter within 31 and three quarters within 153.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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IRCCS SYNLAB SDN