An interventional study of ECG and Transthoracic echography (TTE) in Stroke, sponsored by Brugmann University Hospital. Recruiting at 2 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-30.
Sponsored by Brugmann University Hospital · Not applicable, Interventional, and Basic science
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:
8,255 studies on the registry are indexed under Stroke; 2,056 are open to participants now.
This study's planned enrollment of 250 is above the median of 49 across 6,024 interventional studies indexed under Stroke.
Browse Stroke studies →Brugmann University Hospital is the lead sponsor of 117 studies on the registry; 17 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients, hospitalized at the Stroke Unit of CHU Brugmann and UZ Brussel, after the clinical diagnosis of a first-ever ischemic stroke.
Diagnostic Test: ECG · Diagnostic Test: Transthoracic echography (TTE) · Diagnostic Test: Blood sampling
An electrocardiogram (ECG) is a simple, non-invasive test that records the electrical activity of the heart.
A transthoracic echocardiogram (TTE) is a test that uses ultrasound (sound waves) to create images of the heart.
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).
Heart rate variability (HRV)
Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.
Time frame: Baseline (hospital admission)
Heart rate variability (HRV)
Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.
Time frame: 3 months after baseline
Heart rate variability (HRV)
Heart rate variability is assessed by ECG monitoring and analyzed by means of Kubios software.
Time frame: 12 months after baseline
Transthoracic echography (TTE)
Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).
Time frame: Baseline (hospital admission)
Transthoracic echography (TTE)
Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).
Time frame: 3 months after baseline
Transthoracic echography (TTE)
Cardiac function will be evaluated by a cardiologist with transthoracic echography (TTE).
Time frame: 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.
Time frame: 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.
Time frame: 12 months after baseline
N-terminal pro-brain natriuretic peptide (NT-proBNP)
NT-proBNP blood levels
Time frame: Baseline (hospital admission)
N-terminal pro-brain natriuretic peptide (NT-proBNP)
NT-proBNP blood levels
Time frame: 3 months after baseline
N-terminal pro-brain natriuretic peptide (NT-proBNP)
NT-proBNP blood levels
Time frame: 12 months after baseline
cardiac troponin (cTnT)
cardiac troponin blood levels
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months after baseline
Blood CRP level
C-reactive protein (CRP) level in the blood (inflammatory marker)
Time frame: 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.
Time frame: Baseline (hospital admission)
Stroke localization in the brain
Manual segmentation of the acute ischemic lesion will be performed on the MRI of the brain
Time frame: 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.
Time frame: Baseline (hospital admission)
Global cortical atrophy scale
Visual rating of cerebral atrophy on MRI images. Ranges from 0 (no lesions) to 39.
Time frame: 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.
Time frame: Baseline (hospital admission)
Presence for pre-existing fatigue (yes/no)
Questionnaire (did you experience fatigue before you had your stroke' (yes/no))
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 12 months after baseline
Complete blood count abnormalities: yes/no
Clinical decision based on the analysis of the blood sample results
Time frame: Baseline (hospital admission)
Renal insufficiency: yes/no
Clinical decision based on the analysis of the blood sample results
Time frame: Baseline (hospital admission)
Electrolyte imbalance: yes/no
Clinical decision based on the analysis of the blood sample results
Time frame: Baseline (hospital admission)
Abnormal liver enzymes: yes/no
Clinical decision based on the analysis of the blood sample results
Time frame: Baseline (hospital admission)
Dyslipidemia: yes/no
Clinical decision based on the analysis of the blood sample results
Time frame: Baseline (hospital admission)
Diabetes: yes/no
Clinical decision based on the analysis of the blood sample results
Time frame: Baseline (hospital admission)
Thyroid disorder: yes/no
Clinical decision based on the analysis of the blood sample results
Time frame: Baseline (hospital admission)
Iron deficiency: yes/no
Clinical decision based on the analysis of the blood sample results
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 12 months after baseline
Plan to share: No
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Started Jun 2024 (actual). Primary completion is estimated for Dec 2027, 42 months after the start.
Of 3,108 non-industry interventional studies with no phase under Stroke, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 42 months is above that.
Counting every sponsor, half of 3,252 studies reached it within 23 months; a quarter within 10 and three quarters within 46.
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