[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586124":3},{"organization":4,"armGroups":7,"interventions":28,"overallOfficials":12,"centralContacts":38,"locations":44,"responsibleParty":122,"collaborators":12,"id":125,"slug":126,"hasResults":127,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":131,"eligibilityCriteria":132,"healthyVolunteers":133,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":12,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":47,"whyStopped":12,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Catholic University of the Sacred Heart","OTHER",[8,13,19,24],{"label":9,"type":10,"description":11,"interventionNames":12},"No intervention - Standard of Care","NO_INTERVENTION","Participants will receive traditional lifestyle advices in order to reduce the risk.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Genetic testing - PRS","EXPERIMENTAL","Arm Description: Participants will receive the information of the genetic cardiovascular risk (PRS) and personalized advices.",[18],"Behavioral: Polygenic Risk Score",{"label":20,"type":15,"description":21,"interventionNames":22},"Experimental: Digital intervention - app and wearable device","Arm Description: Participants will receive an app and a wearable device for the evaluation of various parameters.",[23],"Behavioral: Digital app and wearable device",{"label":25,"type":15,"description":26,"interventionNames":27},"Digital intervention and genetic testing - PRS","Arm Description: Participants will receive both app and wearable device and PRS information",[18,23],[29,34],{"type":30,"name":31,"description":32,"armGroupLabels":33,"otherNames":12},"BEHAVIORAL","Polygenic Risk Score","genetic test for the evaluation of cardiovascular risk",[25,14],{"type":30,"name":35,"description":36,"armGroupLabels":37,"otherNames":12},"Digital app and wearable device","a wearable device connected with its app",[25,20],[39],{"name":40,"role":41,"phone":42,"phoneExt":12,"email":43},"Roberta Pastorino","CONTACT","+393495624174","roberta.pastorino@unicatt.it",[45,62,72,82,92,102,112],{"facility":46,"status":47,"city":48,"state":49,"zip":12,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Studio Antonaci","RECRUITING","Rome","Italy","IT",{"type":52,"coordinates":53},"Point",[54,55],12.51133,41.89193,{"lat":55,"lon":54},[58],{"name":59,"role":41,"phone":60,"phoneExt":12,"email":61},"Luciano Antonaci","+393356574532","dott.antonaci@gmail.com",{"facility":63,"status":47,"city":48,"state":12,"zip":12,"country":49,"countryCode":50,"cosmosGeoPoint":64,"geoPoint":66,"contacts":67},"Studio Colletti",{"type":52,"coordinates":65},[54,55],{"lat":55,"lon":54},[68],{"name":69,"role":41,"phone":70,"phoneExt":12,"email":71},"Roberto Colletti","+393933062969","dr.collettimg@gmail.com",{"facility":73,"status":47,"city":48,"state":12,"zip":12,"country":49,"countryCode":50,"cosmosGeoPoint":74,"geoPoint":76,"contacts":77},"Studio Maggiori",{"type":52,"coordinates":75},[54,55],{"lat":55,"lon":54},[78],{"name":79,"role":41,"phone":80,"phoneExt":12,"email":81},"Enrica Maggiori","+393392334787","enricamaggiori@libero.it",{"facility":83,"status":47,"city":48,"state":12,"zip":12,"country":49,"countryCode":50,"cosmosGeoPoint":84,"geoPoint":86,"contacts":87},"Studio Mammucari",{"type":52,"coordinates":85},[54,55],{"lat":55,"lon":54},[88],{"name":89,"role":41,"phone":90,"phoneExt":12,"email":91},"Massimo Mammucari","+393357685440","massimo.mammucari@libero.it",{"facility":93,"status":47,"city":48,"state":12,"zip":12,"country":49,"countryCode":50,"cosmosGeoPoint":94,"geoPoint":96,"contacts":97},"Studio Marra",{"type":52,"coordinates":95},[54,55],{"lat":55,"lon":54},[98],{"name":99,"role":41,"phone":100,"phoneExt":12,"email":101},"Giulia A Marra","3489312237","giuliaantonia.marra@gmail.com",{"facility":103,"status":47,"city":48,"state":12,"zip":12,"country":49,"countryCode":50,"cosmosGeoPoint":104,"geoPoint":106,"contacts":107},"Studio Paoletti",{"type":52,"coordinates":105},[54,55],{"lat":55,"lon":54},[108],{"name":109,"role":41,"phone":110,"phoneExt":12,"email":111},"Filippo Paoletti","+393336479293","filippopaoletti.an@gmail.com",{"facility":113,"status":47,"city":48,"state":12,"zip":12,"country":49,"countryCode":50,"cosmosGeoPoint":114,"geoPoint":116,"contacts":117},"Studio Pasca",{"type":52,"coordinates":115},[54,55],{"lat":55,"lon":54},[118],{"name":119,"role":41,"phone":120,"phoneExt":12,"email":121},"Giulio FM Pasca","+393484267755","giuliofm.pasca@gmail.com",{"type":123,"investigatorFullName":40,"investigatorTitle":124,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100586124","feasibility-of-innovative-approaches-for-personalized-cardiovascular-prevention-100586124",false,"NCT06911294","Feasibility of Innovative Approaches for Personalized Cardiovascular Prevention","Feasibility of InnovaTive Approaches for Personalized Cardiovascular PREVention: Randomized Controlled Pilot Trial and Multidisciplinary Evaluation for National Health Service Implementation","FITPREV","Inclusion Criteria:\n\n* Age 40-69 years;\n* 10 year cardiovascular risk score SCORE2 between 2.5% and 10%.\n* Diagnosis of metabolic syndrome according to the American Heart Association criteria , defined as the presence of three or more of the following:\n\n  * Central or abdominal obesity, measured by waist circumference (greater than 40 inches - 102 cm in men and 35 inches - 89 cm in women).\n  * Elevated triglycerides: levels equal to or greater than 150 mg\u002FdL or use of medication for hypertriglyceridemia.\n  * Low HDL cholesterol levels (less than 40 mg\u002FdL in men and less than 50 mg\u002FdL in women) or use of cholesterol-lowering medication.\n  * Elevated blood pressure: systolic ≥130 mmHg or diastolic ≥85 mmHg, or use of antihypertensive medication.\n  * Elevated fasting blood glucose: ≥100 mg\u002FdL or use of glucose-lowering medication.\n\nExclusion Criteria:\n\n* Diabetes:\n* Familial hypercholesterolemia;\n* Previous cardiovascular events.",true,"ALL","40 Years","69 Years",{"count":138,"type":139},120,"ESTIMATED","INTERVENTIONAL",[142],"NA","The goal of the FITPREV (Feasibility of InnovaTive approaches for personalized cardiovascular PREVention: randomized controlled pilot trial and multidisciplinary evaluation for National Health Service implementation) clinical trial is to study the feasibility of innovative approaches( Polygenic Risk Score and health smartwatch) for personalized primary preventive interventions in cardiovascular diseases (CVD). The main questions it aims to answer are:\n\n* Feasibility of a greater study.\n* Feasibility of the interventions in a realistic setting, such as the medical office of a General Practitioner.\n\nParticipants will be randomized in one of the four parallel arms:\n\n* standard of care;\n* genetic testing for cardiovascular genetic risk (through the cardiovascular Polygenic Risk Score or PRS);\n* digital intervention with a wearable device and its app;\n* digital intervention and genetic testing\n\nThe primary outcomes that are going to be evaluated are patient's and General Practitioners' overall judgment of the study and its feasibility.\n\nSecondarily the efficacy of returning Polygenic Risk Score (PRS) results will be assessed. This will happen on two endpoints: i) change in lifestyle pattern; ii) CVD risk profile modification. The postulated hypothesis is that the achievement of these endpoints is more likely in presence of at least one of the aforementioned interventions than among subjects who receive only traditional risk assessment at baseline.",[145],"Coronary Heart Disease",[147,31],"coronary artery disease","2025-08-04",{"date":150,"type":151},"2025-08-05","ACTUAL",{"date":153,"type":151},"2025-02-10",{"date":155,"type":139},"2026-09-10",{"name":5,"class":6},7]