[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100364592":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":78,"collaborators":80,"id":89,"slug":90,"hasResults":91,"nctId":92,"briefTitle":93,"officialTitle":93,"acronym":94,"eligibilityCriteria":95,"healthyVolunteers":91,"sex":96,"minAge":97,"maxAge":98,"enrollmentInfo":99,"targetDuration":10,"studyType":102,"phases":10,"briefSummary":103,"conditions":104,"keywords":110,"overallStatus":40,"whyStopped":10,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},{"fullName":5,"class":6},"University of Leicester","OTHER",[8,12,15,18,21],{"label":9,"type":10,"description":11,"interventionNames":10},"Primary cohort",null,"Any patient presenting to the Leicester Vascular Institute with SLI during the 2 year recruitment period (minimum 420 patients).",{"label":13,"type":10,"description":14,"interventionNames":10},"Frailty & cognitive additional assessments","Any patient recruited to the primary cohort aged ≥65 years and undergoing an intervention for SLI (minimum 150 patients, target 210 patients).",{"label":16,"type":10,"description":17,"interventionNames":10},"Cardiac MRI additional assessments","Any patient recruited to the primary cohort, with capacity to consent and undergoing an intervention for SLI (minimum 100 patients).",{"label":19,"type":10,"description":20,"interventionNames":10},"Biomarkers additional assessments","Any patient recruited to the primary cohort and undergoing an intervention for SLI (no target recruitment set).",{"label":22,"type":10,"description":23,"interventionNames":10},"Historical cohort","Retrospectively identified cohort of patients presenting to the study site with SLI between 2013 -15 (target 420).",[25],{"name":26,"affiliation":5,"role":27},"Rob D Sayers, MD","STUDY_CHAIR",[29,33],{"name":26,"role":30,"phone":31,"phoneExt":10,"email":32},"CONTACT","+44 (0)116 252 3141","rs152@le.ac.uk",{"name":34,"role":30,"phone":35,"phoneExt":10,"email":36},"Tanya J Payne, BSc","+44 (0)116 258 3867","tjp28@le.ac.uk",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Glenfield Hospital Leicester","RECRUITING","Leicester","Leicestershire","LE3 9QP","United Kingdom","UK",{"type":47,"coordinates":48},"Point",[49,50],-1.13169,52.6386,{"lat":50,"lon":49},[53,56,58,61,63,65,67,69,71,72,74,76],{"name":54,"role":30,"phone":55,"phoneExt":10,"email":36},"Tanya J Payne","+44 (0)116 358 3867",{"name":26,"role":57,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"name":59,"role":60,"phone":10,"phoneExt":10,"email":10},"Matt J Bown, MD","SUB_INVESTIGATOR",{"name":62,"role":60,"phone":10,"phoneExt":10,"email":10},"Thompson G Robinson, MD",{"name":64,"role":60,"phone":10,"phoneExt":10,"email":10},"Gerry P McCann, MD",{"name":66,"role":60,"phone":10,"phoneExt":10,"email":10},"Victoria J Haunton, MD",{"name":68,"role":60,"phone":10,"phoneExt":10,"email":10},"Sally J Singh, PhD",{"name":70,"role":57,"phone":10,"phoneExt":10,"email":10},"Robert SM Davies, MD",{"name":34,"role":60,"phone":10,"phoneExt":10,"email":10},{"name":73,"role":60,"phone":10,"phoneExt":10,"email":10},"Laura J Gray, PhD",{"name":75,"role":60,"phone":10,"phoneExt":10,"email":10},"Harjeet S Rayt, MD",{"name":77,"role":60,"phone":10,"phoneExt":10,"email":10},"Gregory S McMahon, MD",{"type":79,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[81,83,86],{"name":82,"class":6},"University Hospitals, Leicester",{"name":84,"class":85},"National Institute for Health Research, United Kingdom","OTHER_GOV",{"name":87,"class":88},"The George Davies Charitable Trust","UNKNOWN","100364592","leg-ischaemia-management-collaboration-100364592",false,"NCT04027244","Leg Ischaemia Management Collaboration","LIMb","PRIMARY COHORT\n\nInclusion Criteria:\n\n* All patients presenting to the Leicester Vascular Institute with SLI\n\nExclusion Criteria:\n\n* SLI not caused by PAOD\n* Patients undergoing intervention during their index presentation prior to recruitment\n* Patients lacking capacity to consent with no accompanying next of kin, relative, partner or friend who can act as a personal consulted\n* Patients who cannot read, write or understand English\n* Any significant disease or disorder which may either put the patient at risk because of participation in the study, or may influence the results of the study or the patient's ability to participate in the study\n\nFRAILTY \\& COGNITIVE ADDITIONAL ASSESSMENTS\n\nInclusion criteria:\n\n* Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention for SLI\n* Patients aged ≥65 years\n\nExclusion criteria:\n\n* Nil additional\n\nCARDIAC MRI ADDITIONAL ASSESSMENTS\n\nInclusion criteria:\n\n* Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention\n\nExclusion criteria:\n\n* Absolute contraindications to cardiac MRI (Pregnancy, Non-MR safe permanent pacemaker, implanted cardiac defibrillator, intra-auricular implant or intra-cranial clips, severe claustrophobia, unstable angina)\n* Contraindication to gadolinium contrast agent (Known adverse reaction, chronic renal failure (eGFR \\\u003C30mL\u002Fmin\u002F1.73m\\^2))\n* Patients lacking capacity to consent for cardiac MRI\n\nBIOMARKERS ADDITIONAL ASSESSMENTS\n\n* Patients recruited to the primary cohort in whom a decision has been made to undergo an intervention\n\nExclusion criteria:\n\n* Nil additional","ALL","18 Years","110 Years",{"count":100,"type":101},420,"ESTIMATED","OBSERVATIONAL","Single-centre prospective cohort study of patients presenting with severe limb ischaemia (SLI). The primary outcome measure will be 12 month major amputation rate. A historical cohort of patients identified retrospectively will be the comparitor group used to assess the impact of a newly-established rapid-access limb salvage clinic.\n\nPrimary aim:\n\n\\- Determine the proportion of patients with SLI undergoing major lower limb amputation within 12 months of presentation.\n\nSecondary aims:\n\n* Assess clinically important short-, medium- and long-term outcomes in those undergoing and not undergoing amputation\n* Prevalence and degree of frailty and cognitive impairment\n* Pevalence and degree of cardiac disease (detected by stress MRI)\n* Establish a biobank for future biomarker analysis\n* Investigate the role of frailty and cognitive assessments, cardiac MRI and biomarkers in risk-stratification of patients with SLI",[105,106,107,108,109],"Peripheral Arterial Disease","Critical Limb Ischemia","Frailty","Cognitive Impairment","Coronary Artery Disease",[111,112,107,113,114,115],"Peripheral arterial disease","Limb salvage","Cognitive dysfunction","Myocardial perfusion imaging","Biomarkers","2020-11-03",{"date":118,"type":119},"2020-11-04","ACTUAL",{"date":121,"type":119},"2019-05-10",{"date":123,"type":101},"2031-05-09",{"name":5,"class":6},1]