Functional Milk Supplementation to Reduce In-Stent Restenosis in STEMI Patients (SMASOEA Trial)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorRaffaele Marfella
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Functional Bovine Milk
Dietary supplementFunctional milk product enriched with standardised bioactive peptides, provided daily for 12 months.
Non-Functional Bovine Milk
Dietary supplementStandard bovine milk with identical caloric and macronutrient profile to the functionalized milk, without enrichment, provided daily for 12 months.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Functional Milk GroupExperimental treatment 1 intervention
Group B: Non-Functional Milk GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Incidence of In-Stent Restenosis at 12 Months
Proportion of patients presenting in-stent restenosis (ISR) as assessed by coronary computed tomography angiography (CCTA) at 12 months after index percutaneous coronary intervention (PCI) with drug-eluting stent.
Time frame
12 months after PCI2
Major Adverse Cardiovascular Events (MACE)
Composite endpoint of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and hospitalization for heart failure.
Time frame
12 months after PCISecondary outcomes
1
Change in Inflammatory Biomarkers
Change in hsCRP levels (mg/L)
Time frame
12 months after PCI2
Change in Oxidative Stress Parameters
Change from baseline in Change in plasma malondialdehyde (µmol/L).
Time frame
12 months after PCI3
Change in Serum Sirtuin Levels
Change from baseline in serum sirtuins as measured by ELISA.
Time frame
12 months after PCI4
Metabolomic Profile Changes
Variations in plasma metabolomic profiles assessed by LC-MS and GC-MS.
Time frame
12 months after PCISponsors and contacts
Click on the lead sponsor to view all of their trials.
Raffaele Marfella
Lead sponsor
University of Campania Luigi Vanvitelli
Sponsor institution
Ministry of Health, Italy
Collaborator
Source ClinicalTrials.gov
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