[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100458494":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":38,"centralContacts":43,"locations":52,"responsibleParty":69,"collaborators":10,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":73,"sex":79,"minAge":80,"maxAge":10,"enrollmentInfo":81,"targetDuration":10,"studyType":84,"phases":10,"briefSummary":85,"conditions":86,"keywords":90,"overallStatus":55,"whyStopped":10,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"John Paul II Hospital, Krakow","OTHER",[8,16,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Isolated HF Group",null,"Patients with echocardiography - confirmed Heart Failure (HFmrEF and HFrEF) and clinical symptoms (NYHA I-III).",[13,14,15],"Diagnostic Test: Echocardiography","Diagnostic Test: Doppler sonography","Diagnostic Test: Neuropsychological tests",{"label":17,"type":10,"description":18,"interventionNames":19},"HF + CS group","Patients with echocardiography - confirmed Heart Failure (HFmrEF and HFrEF) with NYHA I-III symptoms, who were diagnosed with flow limiting Carotid Stenosis on carotid Doppler ultrasound.",[13,14,15],{"label":21,"type":10,"description":22,"interventionNames":23},"Control group","A cohort of patients without Heart Failure or other significant cardiac pathology and without Carotid Stenosis (a paired propensity match will be performed).",[13,14,15],[25,30,34],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"DIAGNOSTIC_TEST","Echocardiography","Transthoracic echocardiography with standard measurements",[21,17,9],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"Doppler sonography","Transcarotid and transcranial Doppler sonography",[21,17,9],{"type":26,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"Neuropsychological tests","Mini Mental State Examination (MMSE) and Montreal Cognitive Assessment (MoCA)",[21,17,9],[39],{"name":40,"affiliation":41,"role":42},"Piotr Musialek, MD, DPhil","John Paul II Hospital","PRINCIPAL_INVESTIGATOR",[44,48],{"name":40,"role":45,"phone":46,"phoneExt":10,"email":47},"CONTACT","+48126142287","pmusialek@szpitaljp2.krakow.pl",{"name":49,"role":45,"phone":50,"phoneExt":10,"email":51},"Karolina Dzierwa, MD, PhD","+48126143158","kdzierwa@szpitaljp2.krakow.pl",[53],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Department of Cardiac and Vascular Diseases, The John Paul II Hospital","RECRUITING","Krakow","MP","31-202","Poland","PL",{"type":62,"coordinates":63},"Point",[64,65],19.93658,50.06143,{"lat":65,"lon":64},[68],{"name":40,"role":45,"phone":46,"phoneExt":10,"email":47},{"type":70,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100458494","transcranial-doppler-cerebral-blood-flow-and-cognitive-impairment-in-heart-failure-100458494",false,"NCT05250349","TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Heart Failure","TRAnscranial Doppler CErebral Blood Flow and Cognitive IMPAIRment in Patients With Heart Failure and Presence\u002FAbsence of Atherosclerotic Carotid Artery Stenosis","TRACE-IMPAIR","Inclusion Criteria:\n\n* Clinically stable patients (NYHA I-III symptoms) with HF (for at least 6 months) either of ischemic or inflammatory etiology as well as genetic cardiomyopathies\n* Signed informed consent form\n* Consent to imaging studies: echocardiography, carotid and transcranial Doppler sonography and neuropsychological tests (MMSE and MoCA).\n\nExclusion Criteria:\n\n* Co-existing, severe, irreversible disease (e.g. advanced cancer)\n* Previously diagnosed dementia (including severe dementia - MMSE and MoCA score \\\u003C10)\n* Psychiatric condition which may influence cognitive function\n* Acute, decompensated HF\n* Reversible cause of HF - tachyarrhytmic, peripartum or toxic cardiomyopathy, acute myocarditis, acute myocardial infarction\n* Aortic stenosis\n* Cerebral stroke in the preceding 3 months\n* Lack of transcranial Doppler acoustic window\n* Echocardiographic projections precluding adequate measurements\n* Anemia with Hemoglobin \\\u003C 8 g\u002Fdl\n* Alcohol or psychoactive agents abuse","ALL","18 Years",{"count":82,"type":83},300,"ESTIMATED","OBSERVATIONAL","TRACE-IMPAIR is a prospective, clinical study of consecutive patients that evaluates the relationship between heart failure (HF) and cognitive impairment in relation to carotid and cerebral flow. The carotid and cerebral flow will be assessed using Doppler ultrasonography, and cognitive function will be estimated during routine neuropsychological tests.\n\nIt is an observational, three(natural)-group, single-center study. It is also an Academic Registry - the scientific activity of the Faculty of Medicine, Collegium Medicum, Jagiellonian University, and John Paul II Hospital.",[87,88,89],"Heart Failure","Cognitive Impairment","Carotid Stenosis",[89,87,91,92,93,88,94],"Carotid Doppler","Transcranial Doppler","Cerebral Flow","Stroke Volume","2022-02-10",{"date":97,"type":98},"2022-02-22","ACTUAL",{"date":100,"type":98},"2021-09-01",{"date":102,"type":83},"2027-09-01",{"name":5,"class":6},1]