[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538556":3},{"organization":4,"outcomesModule":7,"designInfo":113,"detailedDescription":112,"studyPopulation":112,"armGroups":119,"interventions":128,"overallOfficials":141,"centralContacts":146,"locations":151,"responsibleParty":182,"collaborators":112,"id":184,"slug":112,"hasResults":185,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":112,"eligibilityCriteria":188,"healthyVolunteers":185,"sex":189,"minAge":190,"maxAge":112,"enrollmentInfo":191,"targetDuration":112,"studyType":194,"phases":195,"briefSummary":196,"conditions":197,"keywords":112,"overallStatus":153,"whyStopped":112,"lastUpdateSubmitDate":199,"lastUpdatePostDateStruct":200,"startDateStruct":203,"completionDateStruct":205,"leadSponsor":207,"locationsCount":208},{"fullName":5,"class":6},"Brugmann University Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":44,"otherOutcomes":112},[9,13,15,17,20,21,22,25,26,29,30,31,34,37,38,39,42,43],{"measure":10,"description":11,"timeFrame":12},"Heart rate variability (HRV)","Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.","Baseline (hospital admission)",{"measure":10,"description":11,"timeFrame":14},"3 months after baseline",{"measure":10,"description":11,"timeFrame":16},"12 months after baseline",{"measure":18,"description":19,"timeFrame":12},"Transthoracic echography (TTE)","Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).",{"measure":18,"description":19,"timeFrame":14},{"measure":18,"description":19,"timeFrame":16},{"measure":23,"description":24,"timeFrame":14},"Fatigue Severity Scale (FSS-7)","The 7 items Fatigue Severity Scale (FSS-7) is a method of evaluating the impact of fatigue. The FSS-7 is a questionnaire with 7 statements rated from 1 (disagree) to 7 (agree). No official cut-off has been established, but most studies adopt the approach of using the average score: an average of ≥4 suggests clinically relevant fatigue, while an average \\\u003C4 indicates low to moderate fatigue.",{"measure":23,"description":24,"timeFrame":16},{"measure":27,"description":28,"timeFrame":12},"N-terminal pro-brain natriuretic peptide (NT-proBNP)","NT-proBNP blood levels",{"measure":27,"description":28,"timeFrame":14},{"measure":27,"description":28,"timeFrame":16},{"measure":32,"description":33,"timeFrame":12},"cardiac troponin (cTnT)","cardiac troponin blood levels",{"measure":35,"description":36,"timeFrame":12},"Non-Invasive Blood Pressure (NIBP)","Non-invasive blood pressure (NIBP) is measured continuously using a Finapres device. Outcomes are recorded as real-time systolic, diastolic, and mean arterial pressure values.",{"measure":35,"description":36,"timeFrame":14},{"measure":35,"description":36,"timeFrame":16},{"measure":40,"description":41,"timeFrame":12},"Baroreflex Sensitivity (BRS)","Baroreflex Sensitivity (BRS) quantifies the autonomic regulation of blood pressure by measuring the change in heart rate in response to spontaneous fluctuations in blood pressure. It is calculated from continuous blood pressure and ECG recordings (using Finapres). BRS is expressed in ms\u002FmmHg, with higher values indicating stronger baroreflex function.",{"measure":40,"description":41,"timeFrame":14},{"measure":40,"description":41,"timeFrame":16},[45,48,51,54,57,60,63,66,69,72,73,74,77,80,83,84,85,88,90,92,94,96,98,100,102,105,106,107,110,111],{"measure":46,"description":47,"timeFrame":12},"Blood CRP level","C-reactive protein (CRP) level in the blood (inflammatory marker)",{"measure":49,"description":50,"timeFrame":12},"Blood neutrophil-to-lymphocyte ratio (NLR)","The neutrophil-to-lymphocyte ratio (NLR), calculated by dividing the neutrophil count by the lymphocyte count, is an inflammatory marker.",{"measure":52,"description":53,"timeFrame":12},"Stroke localization in the brain","Manual segmentation of the acute ischemic lesion will be performed on the MRI of the brain",{"measure":55,"description":56,"timeFrame":12},"Fazekas scale","The Fazekas scale is a widely used method to visually rate hyperintense white matter signal abnormalities in magnetic resonance imaging (MRI) data. It ranges from 0 (no lesions) to 3.",{"measure":58,"description":59,"timeFrame":12},"Global cortical atrophy scale","Visual rating of cerebral atrophy on MRI images. Ranges from 0 (no lesions) to 39.",{"measure":61,"description":62,"timeFrame":12},"Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)","The 26-item IQCODE questionnaire is completed by an informant to assess changes in cognitive function over the past 10 years in elderly individuals. Each item is rated on a 5-point scale from 1 (much improved) to 5 (much worse). The total score is calculated as the mean of all items, giving a range of 1-5. A mean score of ≥3.44 indicates significant cognitive decline.",{"measure":64,"description":65,"timeFrame":12},"Presence for pre-existing fatigue (yes\u002Fno)","Questionnaire (did you experience fatigue before you had your stroke' (yes\u002Fno))",{"measure":67,"description":68,"timeFrame":12},"Duration of pre-existing fatigue","Questionnaire ('how long did you experience fatigue' (\\\u003C 1 week, \\\u003C 3 months, 3-6 months and \\> 6 months)",{"measure":70,"description":71,"timeFrame":12},"Patient Health Questionnaire-9 (PHQ-9)","The PHQ-9 is a 9-item questionnaire assessing the frequency of depressive symptoms over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day), giving a total score range of 0-27. Total scores can be interpreted as follows:\n\n0-4: minimal or no depression 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression",{"measure":70,"description":71,"timeFrame":14},{"measure":70,"description":71,"timeFrame":16},{"measure":75,"description":76,"timeFrame":14},"Montreal Cognitive Assessment (MoCA) questionnaire","Questionnaire. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.",{"measure":78,"description":79,"timeFrame":16},"Montreal Cognitive Assessment (MoCA) score","Questionnaire.MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.",{"measure":81,"description":82,"timeFrame":12},"Insomnia Severity Index (ISI)","Insomnia will be assessed by using the Insomnia Severity Index (ISI). The total score is interpreted as follows: absence of insomnia (0-7); sub-threshold insomnia (8-14); moderate insomnia (15-21); and severe insomnia (22-28).",{"measure":81,"description":82,"timeFrame":14},{"measure":81,"description":82,"timeFrame":16},{"measure":86,"description":87,"timeFrame":12},"Complete blood count abnormalities: yes\u002Fno","Clinical decision based on the analysis of the blood sample results",{"measure":89,"description":87,"timeFrame":12},"Renal insufficiency: yes\u002Fno",{"measure":91,"description":87,"timeFrame":12},"Electrolyte imbalance: yes\u002Fno",{"measure":93,"description":87,"timeFrame":12},"Abnormal liver enzymes: yes\u002Fno",{"measure":95,"description":87,"timeFrame":12},"Dyslipidemia: yes\u002Fno",{"measure":97,"description":87,"timeFrame":12},"Diabetes: yes\u002Fno",{"measure":99,"description":87,"timeFrame":12},"Thyroid disorder: yes\u002Fno",{"measure":101,"description":87,"timeFrame":12},"Iron deficiency: yes\u002Fno",{"measure":103,"description":104,"timeFrame":12},"Epworth Sleepiness Scale (ESS)","Description and scoring: the ESS is a questionnaire consisting of 8 daily-life situations in which the patient rates their likelihood of falling asleep on a scale from 0 (would never doze) to 3 (high chance of dozing).\n\nTotal score = sum of the 8 items → possible range 0 to 24.\n\nCommon interpretation:\n\n0-10: normal daytime sleepiness 11-24: excessive daytime sleepiness (higher score = greater sleepiness)",{"measure":103,"description":104,"timeFrame":14},{"measure":103,"description":104,"timeFrame":16},{"measure":108,"description":109,"timeFrame":12},"Generalized Anxiety Disorder scale (GAD-7)","Description and scoring: the GAD-7 is a 7-item questionnaire assessing symptoms of generalized anxiety over the past two weeks. Each item is scored from 0 (not at all) to 3 (nearly every day).\n\nTotal score: sum of all 7 items → possible range 0-21.\n\nCommon interpretation:\n\n0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety",{"measure":108,"description":109,"timeFrame":14},{"measure":108,"description":109,"timeFrame":16},null,{"allocation":114,"interventionModel":115,"interventionModelDescription":112,"primaryPurpose":116,"observationalModel":112,"timePerspective":112,"maskingInfo":117},"NA","SINGLE_GROUP","BASIC_SCIENCE",{"masking":118,"maskingDescription":112,"whoMasked":112},"NONE",[120],{"label":121,"type":122,"description":123,"interventionNames":124},"Stroke patients","EXPERIMENTAL","Patients, hospitalized at the Stroke Unit of CHU Brugmann and UZ Brussel, after the clinical diagnosis of a first-ever ischemic stroke.",[125,126,127],"Diagnostic Test: ECG","Diagnostic Test: Transthoracic echography (TTE)","Diagnostic Test: Blood sampling",[129,134,137],{"type":130,"name":131,"description":132,"armGroupLabels":133,"otherNames":112},"DIAGNOSTIC_TEST","ECG","An electrocardiogram (ECG) is a simple, non-invasive test that records the electrical activity of the heart.",[121],{"type":130,"name":18,"description":135,"armGroupLabels":136,"otherNames":112},"A transthoracic echocardiogram (TTE) is a test that uses ultrasound (sound waves) to create images of the heart.",[121],{"type":130,"name":138,"description":139,"armGroupLabels":140,"otherNames":112},"Blood sampling","Blood sampling will include: complete blood count, serum creatinine and electrolytes, liver enzymes, fast lipid profile, glucose, HbA1C, thyroid-stimulating hormone (TSH), CRP, iron status, cardiac troponin (cTnT), N-terminal pro-brain natriuretic peptide (NT-proBNP).",[121],[142],{"name":143,"affiliation":144,"role":145},"Anissa Ourtani, MD","CHU Brugmann","PRINCIPAL_INVESTIGATOR",[147],{"name":143,"role":148,"phone":149,"phoneExt":112,"email":150},"CONTACT","3224754819","Anissa.OURTANI@chu-brugmann.be",[152,170],{"facility":144,"status":153,"city":154,"state":112,"zip":155,"country":156,"countryCode":157,"cosmosGeoPoint":158,"geoPoint":163,"contacts":164},"RECRUITING","Brussels","1020","Belgium","BE",{"type":159,"coordinates":160},"Point",[161,162],4.34878,50.85045,{"lat":162,"lon":161},[165,168],{"name":166,"role":148,"phone":167,"phoneExt":112,"email":150},"Anissa OURTANI, MD","024754819",{"name":169,"role":145,"phone":112,"phoneExt":112,"email":112},"Anissa OURTANI",{"facility":171,"status":153,"city":154,"state":112,"zip":172,"country":156,"countryCode":157,"cosmosGeoPoint":173,"geoPoint":175,"contacts":176},"UZ Brussel","1090",{"type":159,"coordinates":174},[161,162],{"lat":162,"lon":161},[177,180],{"name":178,"role":148,"phone":112,"phoneExt":112,"email":179},"Sylvie De Raedt, MD","Sylvie.DeRaedt@uzbrussel.be",{"name":181,"role":145,"phone":112,"phoneExt":112,"email":112},"Sylvie De Raedt",{"type":183,"investigatorFullName":112,"investigatorTitle":112,"investigatorAffiliation":112,"oldNameTitle":112,"oldOrganization":112},"SPONSOR","100538556",false,"NCT06292377","Better Understanding of Fatigue After STroke","Inclusion Criteria:\n\n* Age ≥ 18\n* First-ever (suspicion of) ischemic stroke based on clinical examination and\u002For brain imaging\n* Onset \\\u003C 72h at time of inclusion\n* Admitted at the stroke unit of CHU Brugmann and UZ Brussel\n* Ability to participate in assessment of fatigue, cognitive, mood and sleep disturbances\n* Ability to undergo MRI of the brain\n\nExclusion Criteria:\n\n* Unable to speak French or Dutch\n* Pre-existing stroke or other structural brain lesion\n* Life expectancy \\\u003C 1 year\n* Severe language impairment or dementia impeding assessment of fatigue, cognitive, mood and sleep disturbances\n* Pregnancy or wish to become pregnant","ALL","18 Years",{"count":192,"type":193},250,"ESTIMATED","INTERVENTIONAL",[114],"Stroke is worldwide the second most common cause of death following heart attack and the leading cause of disability. Post-stroke fatigue (PSF) is a common complication after stroke and can be defined as 'an overwhelming exhaustion or tiredness, not related to exertion, which does not typically improve with rest'. Fatigue following stroke can be divided into early (\\\u003C 3 months) and late (\\> 3 months) fatigue. PSF can have a considerable impact on a person's everyday activities and quality of life, participation in the rehabilitation process and levels of caregiver burden. Yet no efficient treatment exists to prevent or cure PSF because the pathophysiology remains unclear and seems to be multifaceted.\n\nAutonomic dysfunction is a common complication after stroke, associated with higher morbidity and mortality. An easy tool to measure the function of the autonomic nervous system (ANS) is heart rate variability (HRV), which is defined as the beat-to-beat variation of the heart rate (= interbeat interval (IBI)). It is the result of alterations in the sympathetic and parasympathetic nervous system. In recent systematic reviews, authors stipulate that HRV can be regarded as a prognostic factor for short- and long-term stroke outcomes. HRV can be derived from 24 hours, 5 minutes (short-term) and \\\u003C 5 minutes (ultra-short-term) measurements by applying time-domain and frequency-domain indices.\n\nAutonomic dysfunction has been related to chronic fatigue syndrome, in addition to fatigue in multiple sclerosis, Parkinson's disease and myasthenia gravis. However, to the best of our knowledge, the relationship between autonomic dysfunction and PSF has not yet been fully investigated.\n\nFatigue is also common in cardiovascular diseases, especially in patients with heart failure (HF). HF can contribute to fatigue after stroke, independently of stroke.\n\nCardiac complications after acute ischemic stroke (AIS), such as arrhythmias, cardiac dysfunction and myocardial injury, are frequent. The so-called 'stroke-heart syndrome', a concept introduced in 2018, describes a broad spectrum of cardiac changes observed in 10-20% of patients with AIS within the first month after stroke onset, with a peak in the first 72 hours. A dysregulation in the neural-cardiac control after stroke is suspected to be the cause of the cascade leading to cardiac complications, in which autonomic dysfunction and inflammation seem to be part of the underlying mechanism.\n\nBased on previous studies and by analogy with other neurological diseases, the investigators hypothesize that autonomic dysfunction following AIS contributes to PSF and that patients presenting heart failure as a complication following AIS have an increased risk of PSF.\n\nTo confirm this hypothesis, the investigators will conduct a prospective, interventional study where patients who are hospitalized at the Stroke Unit, within 72 hours after stroke symptom onset, will be included. Evaluation will take place of (a) the relationship between autonomic dysfunction (HRV) and early and late PSF, and of (b) the relationship between cardiac dysfunction and early PSF and late PSF.\n\nThere will also be an investigation into following elements:\n\n* the association between early and late PSF and (a) certain inflammatory markers at admission (CRP, NLR), (b) stroke localization and (c) baseline imaging markers of brain frailty.\n* the role of pre-existing fatigue + pre-existing or post-stroke newly diagnosed cognitive impairment, depression and sleep disturbances on the course of PSF.",[198],"Stroke","2026-03-25",{"date":201,"type":202},"2026-03-30","ACTUAL",{"date":204,"type":202},"2024-06-07",{"date":206,"type":193},"2027-12-31",{"name":5,"class":6},2]