Status:
NOT_YET_RECRUITING
Functional Milk Supplementation to Reduce In-Stent Restenosis in STEMI Patients (SMASOEA Trial)
Lead Sponsor:
Raffaele Marfella
Collaborating Sponsors:
Ministry of Health, Italy
Conditions:
ST-elevation Myocardial Infarction (STEMI)
In-stent Restenosis
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
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 profil...
Detailed Description
Coronary artery disease remains a leading cause of morbidity and mortality worldwide. Despite advances in percutaneous coronary intervention (PCI) and the use of drug-eluting stents (DES), in-stent re...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2027
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT07176104
Start Date
December 1 2025
End Date
August 1 2027
Last Update
November 21 2025
Active Locations (1)
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1
Università degli Studi della Campania "Luigi Vanvitelli" - Dipartimento di Scienze Mediche e Chirurgiche Avanzate
Napoli, Italy, Italy, 80138