[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100606480":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":40,"responsibleParty":65,"collaborators":69,"id":73,"slug":74,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":75,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":25,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":97,"whyStopped":25,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"University of Campania Luigi Vanvitelli","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Functional Milk Group","EXPERIMENTAL","Participants will receive daily supplementation with functionalized bovine milk enriched with bioactive peptides and optimised lipid profile, in addition to guideline-directed secondary prevention therapy, for 12 months.",[13],"Dietary Supplement: Functional Bovine Milk",{"label":15,"type":10,"description":16,"interventionNames":17},"Non-Functional Milk Group","Participants will receive daily supplementation with an isocaloric non-functional bovine milk matched in appearance, taste, and packaging to the functionalized milk, in addition to guideline-directed secondary prevention therapy, for 12 months.",[18],"Dietary Supplement: Non-Functional Bovine Milk",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DIETARY_SUPPLEMENT","Functional Bovine Milk","Functional milk product enriched with standardised bioactive peptides, provided daily for 12 months.",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Non-Functional Bovine Milk","Standard bovine milk with identical caloric and macronutrient profile to the functionalized milk, without enrichment, provided daily for 12 months.",[15],[31,36],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"raffaele Male (M) Marfella, MD, PhD","CONTACT","+390815664174","raffaele.marfella@unicampania.it",{"name":37,"role":33,"phone":38,"phoneExt":25,"email":39},"raffaele Sardu, MD, PhD","+393391639624","celestino.sardu@unicampania.it",[41],{"facility":42,"status":25,"city":43,"state":25,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Università degli Studi della Campania \"Luigi Vanvitelli\" - Dipartimento di Scienze Mediche e Chirurgiche Avanzate","Naples","80138","Italy","IT",{"type":48,"coordinates":49},"Point",[50,51],14.26811,40.85216,{"lat":51,"lon":50},[54,57,60,63],{"name":55,"role":33,"phone":56,"phoneExt":25,"email":35},"Raffaele Male (M) Marfella, MD, PhD","3391639624",{"name":58,"role":33,"phone":59,"phoneExt":25,"email":39},"Celestino Sardu, MD, PhD","+393336664543",{"name":61,"role":62,"phone":25,"phoneExt":25,"email":25},"raffaele Marfella, MD, PhD","PRINCIPAL_INVESTIGATOR",{"name":58,"role":64,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"type":66,"investigatorFullName":67,"investigatorTitle":68,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"SPONSOR_INVESTIGATOR","Raffaele Marfella","Professor",[70],{"name":71,"class":72},"Ministry of Health, Italy","OTHER_GOV","100606480","functional-milk-supplementation-to-reduce-in-stent-restenosis-in-stemi-patients-smasoea-trial-100606480",false,"NCT07176104","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","SMASOEA","Inclusion Criteria:\n\n* Age 18-80 years\n* First ST-elevation myocardial infarction (STEMI) treated with percutaneous coronary intervention (PCI) and drug-eluting stent implantation within the previous 4 weeks\n* Stable clinical condition at enrollment\n* Willingness to adhere to study procedures and dietary supplementation for 12 months\n* Signed informed consent\n\nExclusion Criteria:\n\n* Previous myocardial infarction or coronary revascularization\n* Cardiogenic shock or severe heart failure (NYHA class IV)\n* Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m²) or dialysis\n* Active malignancy or life expectancy \\\u003C1 year\n* Known lactose intolerance or allergy to milk proteins\n* Participation in another interventional clinical trial in the last 30 days","ALL","18 Years","80 Years",{"count":85,"type":86},140,"ESTIMATED","INTERVENTIONAL",[89],"NA","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.",[92,93],"ST-elevation Myocardial Infarction (STEMI)","In-stent Restenosis",[95,96],"ST-Elevation Myocardial Infarction","Inflammation","NOT_YET_RECRUITING","2026-05-05",{"date":100,"type":101},"2026-05-06","ACTUAL",{"date":103,"type":86},"2026-07",{"date":105,"type":86},"2027-08",{"name":67,"class":6},1]