Functional Milk Supplementation to Reduce In-Stent Restenosis in STEMI Patients (SMASOEA Trial)

Starting soon · Not applicable

Conditions studied: ST-elevation Myocardial Infarction (STEMI), In-stent Restenosis

In brief

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.

Key facts

Study ID

NCT07176104

Run by

Raffaele Marfella

People needed

140

Starts

2026-07-01

Expected to finish

2027-08-01

Last updated by the study team

2026-05-06

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Previous myocardial infarction or coronary revascularization
• Cardiogenic shock or severe heart failure (NYHA class IV)
• Severe renal impairment (eGFR <30 mL/min/1.73m²) or dialysis
• Active malignancy or life expectancy <1 year
• Known lactose intolerance or allergy to milk proteins
• Participation in another interventional clinical trial in the last 30 days

Where it is running

• Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento di Scienze Mediche e Chirurgiche Avanzate — Naples, Italy

Full record on ClinicalTrials.gov

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