[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100510112":3},{"organization":4,"outcomesModule":7,"designInfo":27,"detailedDescription":30,"studyPopulation":31,"armGroups":32,"interventions":38,"overallOfficials":43,"centralContacts":51,"locations":59,"responsibleParty":76,"collaborators":79,"id":87,"slug":26,"hasResults":88,"nctId":89,"briefTitle":90,"officialTitle":91,"acronym":92,"eligibilityCriteria":93,"healthyVolunteers":88,"sex":94,"minAge":95,"maxAge":26,"enrollmentInfo":96,"targetDuration":26,"studyType":99,"phases":26,"briefSummary":100,"conditions":101,"keywords":26,"overallStatus":62,"whyStopped":26,"lastUpdateSubmitDate":103,"lastUpdatePostDateStruct":104,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":111,"locationsCount":112},{"fullName":5,"class":6},"Azienda Ospedaliero-Universitaria di Modena","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":26},[9],{"measure":10,"description":11,"timeFrame":12},"Number of cardiovascular events in COPD patients living with frailty vs non-frail COPD. patients.","Number of cardiovascular events (including hospital admissions for cardiovascular events) at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.","12 and 24 months",[14,17,20,23],{"measure":15,"description":16,"timeFrame":12},"All-cause long-term mortality in COPD patients living with frailty vs non-frail COPD patients.","All-cause long-term mortality at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.",{"measure":18,"description":19,"timeFrame":12},"Cardiovascular mortality in COPD patients living with frailty vs non-frail COPD patients.","Long-term cardiovascular mortality at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.",{"measure":21,"description":21,"timeFrame":22},"Prevalence of frailty in COPD.","Baseline, at 12 and 24 months",{"measure":24,"description":25,"timeFrame":12},"Deaths due to COPD in COPD patients living with frailty vs non-frail COPD patients.","Number of deaths due to COPD at 12 and 24 months in COPD patients living with frailty vs non-frail COPD patients.",null,{"allocation":26,"interventionModel":26,"interventionModelDescription":26,"primaryPurpose":26,"observationalModel":28,"timePerspective":29,"maskingInfo":26},"COHORT","PROSPECTIVE","The study will investigate the influence that frailty can have on cardiovascular risk in patients with COPD. The project will assess the association between frailty and all-cause mortality, and the relationship between frailty and cardiovascular mortality, by comparing COPD patients living with frailty vs non-frail COPD patients.\n\nThe study participants will be outpatients with diagnosis of COPD according to the Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines (www.goldcopd.org).\n\nFrailty will be measured using the Clinical Frailty Scale (grades 1-9). Patients who are terminally ill (CFS = 9) will be excluded. Cognitive function will be explored using the Montreal Cognitive Assessment (MoCA) test.\n\nThe follow up will be at 12 and 24 months.","COPD outpatients with diagnosis of COPD according to the GOLD guidelines (www.goldcopd.org).",[33],{"label":34,"type":26,"description":35,"interventionNames":36},"COPD outpatients","Outpatients with COPD. COPD diagnosis confirmed by spirometry and according to Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) guidelines.",[37],"Other: Assessment of cardiovascular events, cardiovascular mortality, all-cause mortality, and mortality due to COPD at 12 and 24 months",[39],{"type":6,"name":40,"description":41,"armGroupLabels":42,"otherNames":26},"Assessment of cardiovascular events, cardiovascular mortality, all-cause mortality, and mortality due to COPD at 12 and 24 months","At 12 and 24 months of follow up, cardiovascular events (including hospital admissions), deaths due to cardiovascular disease, deaths due to all-cause, deaths due to COPD will be recorded in COPD outpatients group.",[34],[44,48],{"name":45,"affiliation":46,"role":47},"Alessia Verduri, PhD","Respiratory Unit-University of Modena (Italy) - Hospital Policlinico Modena","PRINCIPAL_INVESTIGATOR",{"name":45,"affiliation":49,"role":50},"Respiratory Unit-University of Modena (Italy)-Hospital Policlinico Modena","STUDY_DIRECTOR",[52,56],{"name":45,"role":53,"phone":54,"phoneExt":26,"email":55},"CONTACT","+390594225769","alessia.verduri@unimore.it",{"name":57,"role":53,"phone":26,"phoneExt":26,"email":58},"Valentina Ruggieri","valentina.ruggieri@unimore.it",[60],{"facility":61,"status":62,"city":63,"state":26,"zip":64,"country":65,"countryCode":66,"cosmosGeoPoint":67,"geoPoint":72,"contacts":73},"Respiratory Unit - Hospital Policlinico Modena","RECRUITING","Modena","41100","Italy","IT",{"type":68,"coordinates":69},"Point",[70,71],10.92539,44.64783,{"lat":71,"lon":70},[74,75],{"name":45,"role":53,"phone":26,"phoneExt":26,"email":55},{"name":57,"role":53,"phone":26,"phoneExt":26,"email":58},{"type":47,"investigatorFullName":77,"investigatorTitle":78,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Alessia Verduri","Dr Alessia Verduri",[80,83,85],{"name":81,"class":82},"Campus Bio-Medico Universitario di Roma-Medicina Interna - Servizio di Pneumologia","UNKNOWN",{"name":84,"class":82},"Ospedale Sant'Andrea - Azienda Sanitaria Locale di Vercelli-Reparto di Pneumologia",{"name":86,"class":82},"Hospitals - Aneurin Bevan University Heath Board (Wales) - United Kingdom","100510112",false,"NCT05922202","Influence of Frailty on Cardiovascular Events and Mortality in Patients With COPD.","Influence of Frailty on Cardiovascular Events and Mortality in Patients With Chronic Obstructive Pulmonary Disease (COPD): A Multicentre Observational Study.","FrCVCOPD","Inclusion Criteria:\n\n* Patients with age ≥18 years, with diagnosis of COPD of at least 1 year, in stable condition, without acute exacerbation in the last 30 days and\u002For all-cause hospitalisation in the last 3 months\n* Smoking history of ≥ 10 pack\u002Fyears\n* Diagnosis of COPD according to GOLD guidelines (www.goldcopd.org)\n* Individuals able to provide their written informed consent.\n\nExclusion Criteria:\n\n* Concurrent diagnosis of interstitial lung disease\n* Presence of restrictive pattern on spirometry\n* No history of smoking habit\n* Individuals not able to provide their written informed consent.","ALL","40 Years",{"count":97,"type":98},300,"ESTIMATED","OBSERVATIONAL","Observational study on the influence of frailty on cardiovascular risk in COPD.",[102],"Role of Frailty in COPD","2025-08-02",{"date":105,"type":106},"2025-08-05","ACTUAL",{"date":108,"type":106},"2024-02-23",{"date":110,"type":98},"2026-06-30",{"name":5,"class":6},1]