NCT07176104Not yet recruiting
Functional Milk Supplementation to Reduce In-Stent Restenosis in STEMI Patients (SMASOEA Trial)
Effects of Functional Bovine Milk Supplementation on Coronary In-Stent Restenosis and Major Adverse Cardiovascular Events in STEMI Patients Undergoing Primary PCI: A Randomized, Double-Blind, Controlled Trial
Source: ClinicalTrials.gov · Last updated 6 May 2026
Brief summary (registry, in English)
This randomized, double-blind, controlled clinical trial will evaluate the effects of daily supplementation with functionalized bovine milk, enriched with bioactive peptides and optimized lipid profile, on coronary in-stent restenosis and major adverse cardiovascular events (MACE) in patients with first ST-elevation myocardial infarction (STEMI) treated with primary percutaneous coronary intervention (PCI) and drug-eluting stent (DES) implantation. Participants will be randomly assigned to receive either functionalized milk or an isocaloric non-functional milk for 12 months, in addition to standard secondary prevention care. The primary endpoint is the incidence of in-stent restenosis at 12 months, assessed by coronary computed tomography angiography (CCTA). Secondary endpoints include MACE occurrence, metabolic and inflammatory biomarkers, oxidative stress markers, serum sirtuins, metabolomic profiles, and myocardial injury evaluated by cardiac positron emission tomography (PET). The study aims to determine whether functionalized milk can improve cardiovascular outcomes and modulate pathophysiological mechanisms after STEMI.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 12 Aug 2025
- Start date
- 1 Jul 2026
- Primary completion date
- 30 Jun 2027
- Lead sponsor
- Raffaele Marfella
- Diseases
- Coronary artery disease
- NCT number
- NCT07176104
What you commit to
- Study type: Interventional
- Planned participants: 140
- From 1 Jul 2026 to the primary completion date, 30 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous myocardial infarction or coronary revascularization
Other illness
- Cardiogenic shock or severe heart failure (NYHA class IV)
- Active malignancy or life expectancy \<1 year
- Known lactose intolerance or allergy to milk proteins
Lab values
- Severe renal impairment (eGFR \<30 mL/min/1.73m²) or dialysis
Other
- Participation in another interventional clinical trial in the last 30 days
Who the study is looking for
- Age 18-80 years
- First ST-elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention (PCI) and drug-eluting stent implantation within the previous 4 weeks
- Stable clinical condition at enrollment
- Willingness to adhere to study procedures and dietary supplementation for 12 months
- Signed informed consent
Age in the registry: 18 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento di Scienze Mediche e Chirurgiche Avanzate Coordinator of this site? Confirm its status | Naples | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.