Better Understanding of Fatigue After STroke
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Stroke
- 发起方
- Brugmann University Hospital
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Transthoracic echography (TTE)
- 状态
- 招募中
- 最后更新
- 上个月
概览
简要总结
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 (< 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.
Autonomic 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 < 5 minutes (ultra-short-term) measurements by applying time-domain and frequency-domain indices.
Autonomic 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.
Fatigue is also common in cardiovascular diseases, especially in patients with heart failure (HF). HF can contribute to fatigue after stroke, independently of stroke.
Cardiac 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.
Based 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.
To 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.
There will also be an investigation into following elements:
- 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.
- the role of pre-existing fatigue + pre-existing or post-stroke newly diagnosed cognitive impairment, depression and sleep disturbances on the course of PSF.
研究者
Bernard Dachy
Head of Neurology Department
Brugmann University Hospital
入排标准
入选标准
- •First-ever (suspicion of) ischemic stroke based on clinical examination and/or brain imaging
- •Onset \< 72h at time of inclusion
- •Admitted at the stroke unit of CHU Brugmann and UZ Brussel
- •Ability to participate in assessment of fatigue, cognitive, mood and sleep disturbances
- •Ability to undergo MRI of the brain
排除标准
- •Unable to speak French or Dutch
- •Pre-existing stroke or other structural brain lesion
- •Life expectancy \< 1 year
- •Severe language impairment or dementia impeding assessment of fatigue, cognitive, mood and sleep disturbances
- •Pregnancy or wish to become pregnant
结局指标
主要结局
Transthoracic echography (TTE)
时间窗: 12 months after baseline
Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).
N-terminal pro-brain natriuretic peptide (NT-proBNP)
时间窗: 12 months after baseline
NT-proBNP blood levels
Heart rate variability (HRV)
时间窗: 12 months after baseline
Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.
cardiac troponin (cTnT)
时间窗: Baseline (hospital admission)
cardiac troponin blood levels
Transthoracic echography (TTE)
时间窗: Baseline (hospital admission)
Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).
Transthoracic echography (TTE)
时间窗: 3 months after baseline
Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).
N-terminal pro-brain natriuretic peptide (NT-proBNP)
时间窗: Baseline (hospital admission)
NT-proBNP blood levels
N-terminal pro-brain natriuretic peptide (NT-proBNP)
时间窗: 3 months after baseline
NT-proBNP blood levels
Heart rate variability (HRV)
时间窗: Baseline (hospital admission)
Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.
Heart rate variability (HRV)
时间窗: 3 months after baseline
Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.
Fatigue Severity Scale (FSS-7)
时间窗: 3 months after baseline
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 \<4 indicates low to moderate fatigue.
Fatigue Severity Scale (FSS-7)
时间窗: 12 months after baseline
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 \<4 indicates low to moderate fatigue.
Non-Invasive Blood Pressure (NIBP)
时间窗: Baseline (hospital admission)
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.
Non-Invasive Blood Pressure (NIBP)
时间窗: 3 months after baseline
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.
Non-Invasive Blood Pressure (NIBP)
时间窗: 12 months after baseline
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.
Baroreflex Sensitivity (BRS)
时间窗: Baseline (hospital admission)
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/mmHg, with higher values indicating stronger baroreflex function.
Baroreflex Sensitivity (BRS)
时间窗: 3 months after baseline
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/mmHg, with higher values indicating stronger baroreflex function.
Baroreflex Sensitivity (BRS)
时间窗: 12 months after baseline
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/mmHg, with higher values indicating stronger baroreflex function.
次要结局
- Electrolyte imbalance: yes/no(Baseline (hospital admission))
- Stroke localization in the brain(Baseline (hospital admission))
- Fazekas scale(Baseline (hospital admission))
- Global cortical atrophy scale(Baseline (hospital admission))
- Duration of pre-existing fatigue(Baseline (hospital admission))
- Blood CRP level(Baseline (hospital admission))
- Dyslipidemia: yes/no(Baseline (hospital admission))
- Thyroid disorder: yes/no(Baseline (hospital admission))
- Montreal Cognitive Assessment (MoCA) questionnaire(3 months after baseline)
- Presence for pre-existing fatigue (yes/no)(Baseline (hospital admission))
- Diabetes: yes/no(Baseline (hospital admission))
- Iron deficiency: yes/no(Baseline (hospital admission))
- Montreal Cognitive Assessment (MoCA) score(12 months after baseline)
- Insomnia Severity Index (ISI)(12 months after baseline)
- Renal insufficiency: yes/no(Baseline (hospital admission))
- Blood neutrophil-to-lymphocyte ratio (NLR)(Baseline (hospital admission))
- Complete blood count abnormalities: yes/no(Baseline (hospital admission))
- Abnormal liver enzymes: yes/no(Baseline (hospital admission))
- Generalized Anxiety Disorder scale (GAD-7)(3 months after baseline)
- Epworth Sleepiness Scale (ESS)(12 months after baseline)
- Generalized Anxiety Disorder scale (GAD-7)(Baseline (hospital admission))
- Generalized Anxiety Disorder scale (GAD-7)(12 months after baseline)
- Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)(Baseline (hospital admission))
- Patient Health Questionnaire-9 (PHQ-9)(Baseline (hospital admission))
- Patient Health Questionnaire-9 (PHQ-9)(3 months after baseline)
- Patient Health Questionnaire-9 (PHQ-9)(12 months after baseline)
- Insomnia Severity Index (ISI)(Baseline (hospital admission))
- Insomnia Severity Index (ISI)(3 months after baseline)
- Epworth Sleepiness Scale (ESS)(Baseline (hospital admission))
- Epworth Sleepiness Scale (ESS)(3 months after baseline)