DIAGNOSTIC_TEST
ECG
An electrocardiogram (ECG) is a simple, non-invasive test that records the electrical activity of the heart.
Better Understanding of Fatigue After STroke
Status
Recruiting
Phase
Not applicable
Enrollment
250
Locations
2
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DIAGNOSTIC_TEST
Transthoracic echography (TTE)
A transthoracic echocardiogram (TTE) is a test that uses ultrasound (sound waves) to create images of the heart.
DIAGNOSTIC_TEST
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).
Timeline
From registration to results.
First posted
Mar 5, 2024
Study start
Jun 7, 2024
Primary completion
Dec 31, 2027
Study completion
Dec 31, 2027
Results posted
Not reported
Registry updated
Mar 30, 2026
Outcomes
What the study measures.
Primary outcomes
Heart rate variability (HRV)
Time frame · Baseline (hospital admission)
Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.
Heart rate variability (HRV)
Time frame · 3 months after baseline
Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.
Heart rate variability (HRV)
Time frame · 12 months after baseline
Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.
Transthoracic echography (TTE)
Time frame · Baseline (hospital admission)
Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).
Transthoracic echography (TTE)
Time frame · 3 months after baseline
Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).
Transthoracic echography (TTE)
Time frame · 12 months after baseline
Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).
Fatigue Severity Scale (FSS-7)
Time frame · 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)
Time frame · 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.
Secondary outcomes
Blood CRP level
Time frame · Baseline (hospital admission)
C-reactive protein (CRP) level in the blood (inflammatory marker)
Blood neutrophil-to-lymphocyte ratio (NLR)
Time frame · Baseline (hospital admission)
The neutrophil-to-lymphocyte ratio (NLR), calculated by dividing the neutrophil count by the lymphocyte count, is an inflammatory marker.
Stroke localization in the brain
Time frame · Baseline (hospital admission)
Manual segmentation of the acute ischemic lesion will be performed on the MRI of the brain
Fazekas scale
Time frame · Baseline (hospital admission)
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.
Global cortical atrophy scale
Time frame · Baseline (hospital admission)
Visual rating of cerebral atrophy on MRI images. Ranges from 0 (no lesions) to 39.
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
Time frame · Baseline (hospital admission)
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.
Presence for pre-existing fatigue (yes/no)
Time frame · Baseline (hospital admission)
Questionnaire (did you experience fatigue before you had your stroke' (yes/no))
Duration of pre-existing fatigue
Time frame · Baseline (hospital admission)
Questionnaire ('how long did you experience fatigue' (\< 1 week, \< 3 months, 3-6 months and \> 6 months)
Patient Health Questionnaire-9 (PHQ-9)
Time frame · Baseline (hospital admission)
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: 0-4: minimal or no depression 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression
Patient Health Questionnaire-9 (PHQ-9)
Time frame · 3 months after baseline
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: 0-4: minimal or no depression 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- Not reported
- Sex
- ALL
- Healthy volunteers
- No
Inclusion Criteria: * Age ≥ 18 * 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 Exclusion Criteria: * 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
Study locations
2 registered sites.
Belgium. Showing up to 24 locations stored in the fast local snapshot.
CHU Brugmann
Brussels, Belgium
UZ Brussel
Brussels, Belgium
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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