StrokeNCT06292377
Better Understanding of Fatigue After STroke
A study testing ECG, Transthoracic echography (TTE) and Blood sampling in people with Stroke, run by Brugmann University Hospital at 2 sites in Belgium.
Trial summary
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'. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- ECG, Transthoracic echography (TTE) and Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 2 sitesBelgium
- Study dates
- 7 Jun 2024to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium2 sites, 2 recruiting
- Recruiting
CHU Brugmann
Brussels, 1020
Anissa OURTANI, MD, 024754819, Anissa.OURTANI@chu-brugmann.be
Anissa OURTANI
- Recruiting
UZ Brussel
Brussels, 1090
Sylvie De Raedt, MD, Sylvie.DeRaedt@uzbrussel.be
Sylvie De Raedt
About this study
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.
Read more
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.
- Conditions
- Stroke
- Being tested
- ECG, Transthoracic echography (TTE), Blood sampling
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ECGDiagnostic test
An electrocardiogram (ECG) is a simple, non-invasive test that records the electrical activity of the heart.
Transthoracic echography (TTE)Diagnostic test
A transthoracic echocardiogram (TTE) is a test that uses ultrasound (sound waves) to create images of the heart.
Blood samplingDiagnostic test
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ECG; Diagnostic Test: Transthoracic echography (TTE); Diagnostic Test: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate variability (HRV)
Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.
Measured: Baseline (hospital admission)
Heart rate variability (HRV)
Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.
Measured: 3 months after baseline
Heart rate variability (HRV)
Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.
Measured: 12 months after baseline
Transthoracic echography (TTE)
Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).
Measured: Baseline (hospital admission)
Transthoracic echography (TTE)
Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).
Measured: 3 months after baseline
Transthoracic echography (TTE)
Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).
Measured: 12 months after baseline
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 <4 indicates low to moderate fatigue.
Measured: 3 months after baseline
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 <4 indicates low to moderate fatigue.
Measured: 12 months after baseline
N-terminal pro-brain natriuretic peptide (NT-proBNP)
NT-proBNP blood levels
Measured: Baseline (hospital admission)
N-terminal pro-brain natriuretic peptide (NT-proBNP)
NT-proBNP blood levels
Measured: 3 months after baseline
N-terminal pro-brain natriuretic peptide (NT-proBNP)
NT-proBNP blood levels
Measured: 12 months after baseline
cardiac troponin (cTnT)
cardiac troponin blood levels
Measured: Baseline (hospital admission)
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.
Measured: Baseline (hospital admission)
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.
Measured: 3 months after baseline
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.
Measured: 12 months after baseline
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/mmHg, with higher values indicating stronger baroreflex function.
Measured: Baseline (hospital admission)
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/mmHg, with higher values indicating stronger baroreflex function.
Measured: 3 months after baseline
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/mmHg, with higher values indicating stronger baroreflex function.
Measured: 12 months after baseline
Secondary outcomes (30)
Blood CRP level
C-reactive protein (CRP) level in the blood (inflammatory marker)
Measured: Baseline (hospital admission)
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.
Measured: Baseline (hospital admission)
Stroke localization in the brain
Manual segmentation of the acute ischemic lesion will be performed on the MRI of the brain
Measured: Baseline (hospital admission)
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.
Measured: Baseline (hospital admission)
Global cortical atrophy scale
Visual rating of cerebral atrophy on MRI images. Ranges from 0 (no lesions) to 39.
Measured: Baseline (hospital admission)
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.
Measured: Baseline (hospital admission)
Presence for pre-existing fatigue (yes/no)
Questionnaire (did you experience fatigue before you had your stroke' (yes/no))
Measured: Baseline (hospital admission)
Duration of pre-existing fatigue
Questionnaire ('how long did you experience fatigue' (< 1 week, < 3 months, 3-6 months and > 6 months)
Measured: Baseline (hospital admission)
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:
0-4: minimal or no depression 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression
Measured: Baseline (hospital admission)
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:
0-4: minimal or no depression 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression
Measured: 3 months after baseline
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:
0-4: minimal or no depression 5-9: mild depression 10-14: moderate depression 15-19: moderately severe depression 20-27: severe depression
Measured: 12 months after baseline
Montreal Cognitive Assessment (MoCA) questionnaire
Questionnaire. MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.
Measured: 3 months after baseline
Montreal Cognitive Assessment (MoCA) score
Questionnaire.MoCA scores range between 0 and 30. A score of 26 or over is considered to be normal.
Measured: 12 months after baseline
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).
Measured: Baseline (hospital admission)
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).
Measured: 3 months after baseline
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).
Measured: 12 months after baseline
Complete blood count abnormalities: yes/no
Clinical decision based on the analysis of the blood sample results
Measured: Baseline (hospital admission)
Renal insufficiency: yes/no
Clinical decision based on the analysis of the blood sample results
Measured: Baseline (hospital admission)
Electrolyte imbalance: yes/no
Clinical decision based on the analysis of the blood sample results
Measured: Baseline (hospital admission)
Abnormal liver enzymes: yes/no
Clinical decision based on the analysis of the blood sample results
Measured: Baseline (hospital admission)
Dyslipidemia: yes/no
Clinical decision based on the analysis of the blood sample results
Measured: Baseline (hospital admission)
Diabetes: yes/no
Clinical decision based on the analysis of the blood sample results
Measured: Baseline (hospital admission)
Thyroid disorder: yes/no
Clinical decision based on the analysis of the blood sample results
Measured: Baseline (hospital admission)
Iron deficiency: yes/no
Clinical decision based on the analysis of the blood sample results
Measured: Baseline (hospital admission)
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).
Total score = sum of the 8 items → possible range 0 to 24.
Common interpretation:
0-10: normal daytime sleepiness 11-24: excessive daytime sleepiness (higher score = greater sleepiness)
Measured: Baseline (hospital admission)
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).
Total score = sum of the 8 items → possible range 0 to 24.
Common interpretation:
0-10: normal daytime sleepiness 11-24: excessive daytime sleepiness (higher score = greater sleepiness)
Measured: 3 months after baseline
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).
Total score = sum of the 8 items → possible range 0 to 24.
Common interpretation:
0-10: normal daytime sleepiness 11-24: excessive daytime sleepiness (higher score = greater sleepiness)
Measured: 12 months after baseline
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).
Total score: sum of all 7 items → possible range 0-21.
Common interpretation:
0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety
Measured: Baseline (hospital admission)
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).
Total score: sum of all 7 items → possible range 0-21.
Common interpretation:
0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety
Measured: 3 months after baseline
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).
Total score: sum of all 7 items → possible range 0-21.
Common interpretation:
0-4: minimal anxiety 5-9: mild anxiety 10-14: moderate anxiety 15-21: severe anxiety
Measured: 12 months after baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start7 Jun 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brugmann University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anissa Ourtani, MD, Principal investigator, CHU Brugmann
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06292377
- Sponsor's protocol ID
- BRUFAST
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Better Understanding of Fatigue After STroke
- ClinicalTrials.gov ID
- NCT06292377
- Acronym / sponsor ID
- BRUFAST
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Brugmann University HospitalUniversity, hospital or other
- Study start
- 7 Jun 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 5 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Stroke patients | Experimental | Diagnostic Test: ECG, Diagnostic Test: Transthoracic echography (TTE), Diagnostic Test: Blood samplingPatients, hospitalized at the Stroke Unit of CHU Brugmann and UZ Brussel, after the clinical diagnosis of a first-ever ischemic stroke. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ECGAn electrocardiogram (ECG) is a simple, non-invasive test that records the electrical activity of the heart. | Diagnostic test | Stroke patients |
| Transthoracic echography (TTE)A transthoracic echocardiogram (TTE) is a test that uses ultrasound (sound waves) to create images of the heart. | Diagnostic test | Stroke patients |
| Blood samplingBlood 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). | Diagnostic test | Stroke patients |
Primary outcome
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.
N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time frame: Baseline (hospital admission)
NT-proBNP blood levels
N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time frame: 3 months after baseline
NT-proBNP blood levels
N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time frame: 12 months after baseline
NT-proBNP blood levels
cardiac troponin (cTnT)
Time frame: Baseline (hospital admission)
cardiac troponin blood levels
Non-Invasive Blood Pressure (NIBP)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
30 secondary outcomes
Blood CRP level
Time frame: Baseline (hospital admission)
Blood neutrophil-to-lymphocyte ratio (NLR)
Time frame: Baseline (hospital admission)
Stroke localization in the brain
Time frame: Baseline (hospital admission)
Fazekas scale
Time frame: Baseline (hospital admission)
Global cortical atrophy scale
Time frame: Baseline (hospital admission)
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
Time frame: Baseline (hospital admission)
Presence for pre-existing fatigue (yes/no)
Time frame: Baseline (hospital admission)
Duration of pre-existing fatigue
Time frame: Baseline (hospital admission)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Baseline (hospital admission)
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 3 months after baseline
Patient Health Questionnaire-9 (PHQ-9)
Time frame: 12 months after baseline
Montreal Cognitive Assessment (MoCA) questionnaire
Time frame: 3 months after baseline
Montreal Cognitive Assessment (MoCA) score
Time frame: 12 months after baseline
Insomnia Severity Index (ISI)
Time frame: Baseline (hospital admission)
Insomnia Severity Index (ISI)
Time frame: 3 months after baseline
Insomnia Severity Index (ISI)
Time frame: 12 months after baseline
Complete blood count abnormalities: yes/no
Time frame: Baseline (hospital admission)
Renal insufficiency: yes/no
Time frame: Baseline (hospital admission)
Electrolyte imbalance: yes/no
Time frame: Baseline (hospital admission)
Abnormal liver enzymes: yes/no
Time frame: Baseline (hospital admission)
Dyslipidemia: yes/no
Time frame: Baseline (hospital admission)
Diabetes: yes/no
Time frame: Baseline (hospital admission)
Thyroid disorder: yes/no
Time frame: Baseline (hospital admission)
Iron deficiency: yes/no
Time frame: Baseline (hospital admission)
Epworth Sleepiness Scale (ESS)
Time frame: Baseline (hospital admission)
Epworth Sleepiness Scale (ESS)
Time frame: 3 months after baseline
Epworth Sleepiness Scale (ESS)
Time frame: 12 months after baseline
Generalized Anxiety Disorder scale (GAD-7)
Time frame: Baseline (hospital admission)
Generalized Anxiety Disorder scale (GAD-7)
Time frame: 3 months after baseline
Generalized Anxiety Disorder scale (GAD-7)
Time frame: 12 months after baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anissa Ourtani, MD principal investigator
CHU Brugmann
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ECG, Transthoracic echography (TTE) and Blood sampling in people with Stroke, run by Brugmann University Hospital at 2 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anissa Ourtani, MD (3224754819, Anissa.OURTANI@chu-brugmann.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate variability (HRV) (time frame: Baseline (hospital admission)). The study lists 18 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.