Lacunar StrokeLACUNAR_CANCT06354881
The Relationship Between Controlling Risk Factors and Cerebral Haemodynamics in Lacunar Stroke
An observational study of Lacunar Stroke, run by University of Leicester at 1 site in United Kingdom.
Trial summary
The goal of this observational study is to look at differences in brain blood flow before and after management of risk factors such as high blood pressure and diabetes in patients with lacunar stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lacunar Stroke
- What is being tested?
- Transcranial Doppler Ultrasonography (TCD) during sit-stand manoeuvres
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 May 2024to Mar 2026
- Phase
- Observational
- 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
Study population: The participants will be recruited from Leicester Royal Infirmary TIA clinic or stroke ward.
Who may be able to join
- Adults aged between 18-120 years.
- Diagnosis of lacunar stroke syndrome.
- New diagnosis or known diagnosis of hypertension and/or diabetes.
Who cannot join
- Those who lack capacity can have a personal consultee consent to the study if they can still perform study requirements such as the sit-stand manoeuvre. Those who either cannot perform the manoeuvre or do not have a personal consultee to allow them to consent, are not able to take part.
- Those with poorly controlled medical comorbidities affecting cerebral haemodynamics. (eg., heart failure).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE1 5WW
Amit Mistri, amit.mistri@uhl-tr.nhs.uk
About this study
Official title: Understanding the Relationship Between Controlling Risk Factors and Cerebral Haemodynamic Changes in Lacunar Stroke, and Its Interaction With Ageing
The goal of this observational study is to look at differences in brain blood flow before and after management of risk factors such as high blood pressure and diabetes in patients with lacunar stroke. Participants will be asked to undergo a simple brain blood flow assessment at their initial appointment, whereby they will be asked to sit and stand twice. The patients will then be asked for a follow-up assessment 4 weeks after, identical to the first. This will allow us to look at any changes in brain blood flow from before management of risk factors and 4 weeks after management of risk factors.
Read the detailed description
Stroke is the second major cause of death across the world leading to high mortality rates and leaving those who experience stroke with a poor quality of life. Lacunar stroke accounts for a quarter of ischemic stroke events and can occur at any age, but is more frequent in the older generation (>65 years) yet not uncommon in younger patients. Lacunar stroke is caused by small vessel disease, whereby occlusions or thrombi occur in the small vessels found deep in the brain structures, around the circle of Willis. This event leads to a decrease in blood supply to certain areas of the brain and damage to surrounding tissues, leaving the brain in a vulnerable state. Further events are then likely to occur such as recurrent stroke, intracranial haemorrhage, additional ischemic events, prolonging symptoms and increasing the risk of damage to the brain. Even though lacunar infarcts occur only in the small vessels of the brain, cognitive impairment is commonly seen post-lacunar stroke emphasising the importance of understanding the trajectory of cerebral haemodynamics after a lacunar infarction. Common treatments involve the use of anticoagulants, antiplatelet therapies (both to stop further blood clots forming), blood pressure (BP) lowering agents (reducing BP to reduce fluctuations in cerebral blood flow) and the management of hyperglycaemia (to help reduce damage to blood vessels).
Cerebral autoregulation (CA) plays a large part in regulating cerebral blood flow (CBF), through maintaining cerebral perfusion, even with fluctuating BP. It does this by regulating the cerebral vasculature through adjustments in vessel diameter. CA has been assessed at rest and challenged with paradigms in healthy volunteers and lacunar stroke patients, however comparisons between younger and older lacunar events incorporating risk factors has not been looked at. The difference in CA phenotype between those with uncontrolled high-risk cardiometabolic factors (often younger patients) and those with moderate/severe small vessel disease and recurrent lacunar stroke syndromes (often older patients) is unknown. Therefore, exploring different risk factors and the different lacunar disease phenotypes is important to identify any differences in cerebral haemodynamics.
Assessing dynamic CA (dCA) in response to fluctuations in BP represents how CA responds to BP fluctuations in the body, allowing better application to the human vasculature, compared to assessing static CA. Multiple paradigms and manoeuvres have been used to assess dCA by inducing a rapid change in BP, but both patient tolerability and ability to measure dCA accurately need to be considered for this study. The sit-stand manoeuvre is a clinically applicable manoeuvre which can be done both in the ward and laboratory with minimal stress to the patient. This manoeuvre has been evaluated in a published review and compared to a thigh-cuff technique which has been used extensively in previous research. The thigh-cuff technique induces a rapid change in arterial blood pressure (ABP) through the rapid deflation of the thigh cuff. However, this repeated action can be painful for some participants making it difficult to apply clinically to frail patients leading to issues of unsuccessful repeats. The review found that autoregulatory index (ARI) values were similar across both the sit-stand and thigh-cuff manoeuvres, showing sit-stand is an accurate manoeuvre to measure CA. The sit-stand manoeuvre was also better tolerated compared to the thigh-cuff.
Following up patients post-stroke as high-risk factors are controlled will help understand changes in CA and could help guide the timing of interventions to manipulate BP and potentially for the impact of rehabilitation programmes.
Lacunar stroke is one of the most common types of stroke, occurring in both younger and older generations. Some studies have observed impaired brain blood flow regulation (cerebral autoregulation) in a cohort of ~57 years of age (median), which has also been seen in those with small vessel disease. Small vessel disease is often seen in older patients who often present with recurrent lacunar strokes despite earlier management of risk factors.
By targeting a younger cohort with uncontrolled risk factors (hypertension and diabetes), the investigators aim to perform a more comprehensive study to investigate the haemodynamic consequences of lacunar strokes in this group. This would be done by using Transcranial Doppler ultrasound (TDC) to measure CBv in patients who are diagnosed with a lacunar stroke and have undiagnosed diabetes and/or hypertension at their initial appointment. To measure a dCA response, the sit-stand manoeuvre will be used. These patients would then receive management of their risk-factors and would be asked to undergo another TCD assessment 4 weeks after their initial appointment. Data would be collected and analysed to look at any differences in cerebral haemodynamics between before and after management of such risk factors.
- Conditions
- Lacunar Stroke
- Being tested
- Transcranial Doppler Ultrasonography (TCD) during sit-stand manoeuvres
- Keywords
- Lacunar, Stroke, Cerebral Autoregulation, Cerebral Blood Flow
- Medical subject headings
- Stroke, Lacunar, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial Doppler Ultrasonography (TCD) during sit-stand manoeuvresDevice
TCD will be used to measure the cerebral blood flow in the middle and posterior cerebral arteries. This will be done at rest and during two sit-stand manoeuvres, whereby the participant will be asked to stand (from a seated position) and stay standing for 1 minute. The participant will then be given time to recover before repeating the manoeuvre. This will occur at the first visit and the follow-up visit 4 weeks after.
| Study group | Role | What they receive |
|---|---|---|
| Lacunar Stroke Syndrome Patients | Patients who have been diagnosed with lacunar stroke syndrome. This is a non-intervention study so no intervention will be given. However, the investigators will observe the changes in cerebral haemodynamics of this group before and after they have been given medications to help control hypertension and/or diabetes which are common risk factors of lacunar stroke syndrome. Receives: Device: Transcranial Doppler Ultrasonography (TCD) during sit-stand manoeuvres |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cerebral blood velocity measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes.
Absolute values (cm/s) and percentage change (%) in cerebral blood velocity measurements before and after management of uncontrolled risk-factors in lacunar stroke patients.
Measured: From enrolment to the end of the follow-up measurements at 4 weeks.
Arterial blood pressure measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes.
Absolute values (mmHg) and percentage change (%) in arterial blood pressure measurements before and after management of uncontrolled risk-factors in lacunar stroke patients.
Measured: From enrolment to the end of the follow-up measurements at 4 weeks.
Heart rate measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes.
Absolute values (bpm) and percentage change (%) in heart rate measurements before and after management of uncontrolled risk-factors in lacunar stroke patients.
Measured: From enrolment to the end of the follow-up measurements at 4 weeks.
End-tidal carbon dioxide measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes.
Absolute values (mmHg) and percentage change (%) in heart rate measurements before and after management of uncontrolled risk-factors in lacunar stroke patients.
Measured: From enrolment to the end of the follow-up measurements at 4 weeks.
Compare cerebral haemodynamics in lacunar stroke patients with older patients experiencing advanced chronic cerebrovascular disease with lacunar stroke syndromes, whose risk-factors are already managed.(CA).
Efficiency of regulatory mechanisms will be analysed through measuring cerebral autoregulation.
Measured: Data collected from enrolment to the end of the follow-up measurements at 4 weeks. Comparisons to other data and other studies to be done at analysis stage.
Compare cerebral haemodynamics in lacunar stroke patients with older patients experiencing advanced chronic cerebrovascular disease with lacunar stroke syndromes, whose risk-factors are already managed. (VMR).
Efficiency of regulatory mechanisms will be analysed through measuring vasomotor reactivity.
Measured: Data collected from enrolment to the end of the follow-up measurements at 4 weeks. Comparisons to other data and other studies to be done at analysis stage.
Compare cerebral haemodynamics in lacunar stroke patients with older patients experiencing advanced chronic cerebrovascular disease with lacunar stroke syndromes, whose risk-factors are already managed.(ARI).
Efficiency of regulatory mechanisms will be analysed through measuring the autoregulatory index.
Measured: Data collected from enrolment to the end of the follow-up measurements at 4 weeks. Comparisons to other data and other studies to be done at analysis stage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start2 May 2024
- Primary completionMar 2026 (estimated)
- Study completionMar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lacunar 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leicester
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation, University Hospitals, Leicester
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354881
- Sponsor's protocol ID
- 0967
- Other IDs
- TM61008S3
- Acronym
- LACUNAR_CA
- Status last verified
- Mar 2025
- First submitted
- 19 Mar 2024
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual patient data will not be shared, however once analysed and combined (statistically through mean averages etc), the results will be compiled into a report and submitted to a relevant journal, allowing researchers to view them.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding the Relationship Between Controlling Risk Factors and Cerebral Haemodynamic Changes in Lacunar Stroke, and Its Interaction With Ageing
- ClinicalTrials.gov ID
- NCT06354881
- Acronym / sponsor ID
- LACUNAR_CA / 0967
- Conditions
- Lacunar Stroke
- Keywords
- Lacunar, Stroke, Cerebral Autoregulation, Cerebral Blood Flow
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of LeicesterUniversity, hospital or other
- Collaborators
- British Heart Foundation, University Hospitals, Leicester
- Study start
- 2 May 2024 (actual)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- Mar 2026 (estimated)
- First posted
- 9 Apr 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.
The goal of this observational study is to look at differences in brain blood flow before and after management of risk factors such as high blood pressure and diabetes in patients with lacunar stroke. Participants will be asked to undergo a simple brain blood flow assessment at their initial appointment, whereby they will be asked to sit and stand twice. The patients will then be asked for a follow-up assessment 4 weeks after, identical to the first. This will allow us to look at any changes in brain blood flow from before management of risk factors and 4 weeks after management of risk factors.
Detailed description
Stroke is the second major cause of death across the world leading to high mortality rates and leaving those who experience stroke with a poor quality of life. Lacunar stroke accounts for a quarter of ischemic stroke events and can occur at any age, but is more frequent in the older generation (>65 years) yet not uncommon in younger patients. Lacunar stroke is caused by small vessel disease, whereby occlusions or thrombi occur in the small vessels found deep in the brain structures, around the circle of Willis. This event leads to a decrease in blood supply to certain areas of the brain and damage to surrounding tissues, leaving the brain in a vulnerable state. Further events are then likely to occur such as recurrent stroke, intracranial haemorrhage, additional ischemic events, prolonging symptoms and increasing the risk of damage to the brain. Even though lacunar infarcts occur only in the small vessels of the brain, cognitive impairment is commonly seen post-lacunar stroke emphasising the importance of understanding the trajectory of cerebral haemodynamics after a lacunar infarction. Common treatments involve the use of anticoagulants, antiplatelet therapies (both to stop further blood clots forming), blood pressure (BP) lowering agents (reducing BP to reduce fluctuations in cerebral blood flow) and the management of hyperglycaemia (to help reduce damage to blood vessels).
Cerebral autoregulation (CA) plays a large part in regulating cerebral blood flow (CBF), through maintaining cerebral perfusion, even with fluctuating BP. It does this by regulating the cerebral vasculature through adjustments in vessel diameter. CA has been assessed at rest and challenged with paradigms in healthy volunteers and lacunar stroke patients, however comparisons between younger and older lacunar events incorporating risk factors has not been looked at. The difference in CA phenotype between those with uncontrolled high-risk cardiometabolic factors (often younger patients) and those with moderate/severe small vessel disease and recurrent lacunar stroke syndromes (often older patients) is unknown. Therefore, exploring different risk factors and the different lacunar disease phenotypes is important to identify any differences in cerebral haemodynamics.
Assessing dynamic CA (dCA) in response to fluctuations in BP represents how CA responds to BP fluctuations in the body, allowing better application to the human vasculature, compared to assessing static CA. Multiple paradigms and manoeuvres have been used to assess dCA by inducing a rapid change in BP, but both patient tolerability and ability to measure dCA accurately need to be considered for this study. The sit-stand manoeuvre is a clinically applicable manoeuvre which can be done both in the ward and laboratory with minimal stress to the patient. This manoeuvre has been evaluated in a published review and compared to a thigh-cuff technique which has been used extensively in previous research. The thigh-cuff technique induces a rapid change in arterial blood pressure (ABP) through the rapid deflation of the thigh cuff. However, this repeated action can be painful for some participants making it difficult to apply clinically to frail patients leading to issues of unsuccessful repeats. The review found that autoregulatory index (ARI) values were similar across both the sit-stand and thigh-cuff manoeuvres, showing sit-stand is an accurate manoeuvre to measure CA. The sit-stand manoeuvre was also better tolerated compared to the thigh-cuff.
Following up patients post-stroke as high-risk factors are controlled will help understand changes in CA and could help guide the timing of interventions to manipulate BP and potentially for the impact of rehabilitation programmes.
Lacunar stroke is one of the most common types of stroke, occurring in both younger and older generations. Some studies have observed impaired brain blood flow regulation (cerebral autoregulation) in a cohort of ~57 years of age (median), which has also been seen in those with small vessel disease. Small vessel disease is often seen in older patients who often present with recurrent lacunar strokes despite earlier management of risk factors.
By targeting a younger cohort with uncontrolled risk factors (hypertension and diabetes), the investigators aim to perform a more comprehensive study to investigate the haemodynamic consequences of lacunar strokes in this group. This would be done by using Transcranial Doppler ultrasound (TDC) to measure CBv in patients who are diagnosed with a lacunar stroke and have undiagnosed diabetes and/or hypertension at their initial appointment. To measure a dCA response, the sit-stand manoeuvre will be used. These patients would then receive management of their risk-factors and would be asked to undergo another TCD assessment 4 weeks after their initial appointment. Data would be collected and analysed to look at any differences in cerebral haemodynamics between before and after management of such risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lacunar Stroke Syndrome Patients | – | Device: Transcranial Doppler Ultrasonography (TCD) during sit-stand manoeuvresPatients who have been diagnosed with lacunar stroke syndrome. This is a non-intervention study so no intervention will be given. However, the investigators will observe the changes in cerebral haemodynamics of this group before and after they have been given medications to help control hypertension and/or diabetes which are common risk factors of lacunar stroke syndrome. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The participants will be recruited from Leicester Royal Infirmary TIA clinic or stroke ward.
Key inclusion criteria (3 listed)
- Adults aged between 18-120 years.
- Diagnosis of lacunar stroke syndrome.
- New diagnosis or known diagnosis of hypertension and/or diabetes.
Key exclusion criteria (2 listed)
- Those who lack capacity can have a personal consultee consent to the study if they can still perform study requirements such as the sit-stand manoeuvre. Those who either cannot perform the manoeuvre or do not have a personal consultee to allow them to consent, are not able to take part.
- Those with poorly controlled medical comorbidities affecting cerebral haemodynamics. (eg., heart failure).
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 |
|---|---|---|
| Transcranial Doppler Ultrasonography (TCD) during sit-stand manoeuvresTCD will be used to measure the cerebral blood flow in the middle and posterior cerebral arteries. This will be done at rest and during two sit-stand manoeuvres, whereby the participant will be asked to stand (from a seated position) and stay standing for 1 minute. The participant will then be given time to recover before repeating the manoeuvre. This will occur at the first visit and the follow-up visit 4 weeks after. | Device | Lacunar Stroke Syndrome Patients |
Primary outcome
Cerebral blood velocity measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes.
Time frame: From enrolment to the end of the follow-up measurements at 4 weeks.
Absolute values (cm/s) and percentage change (%) in cerebral blood velocity measurements before and after management of uncontrolled risk-factors in lacunar stroke patients.
Arterial blood pressure measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes.
Time frame: From enrolment to the end of the follow-up measurements at 4 weeks.
Absolute values (mmHg) and percentage change (%) in arterial blood pressure measurements before and after management of uncontrolled risk-factors in lacunar stroke patients.
Heart rate measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes.
Time frame: From enrolment to the end of the follow-up measurements at 4 weeks.
Absolute values (bpm) and percentage change (%) in heart rate measurements before and after management of uncontrolled risk-factors in lacunar stroke patients.
End-tidal carbon dioxide measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes.
Time frame: From enrolment to the end of the follow-up measurements at 4 weeks.
Absolute values (mmHg) and percentage change (%) in heart rate measurements before and after management of uncontrolled risk-factors in lacunar stroke patients.
Compare cerebral haemodynamics in lacunar stroke patients with older patients experiencing advanced chronic cerebrovascular disease with lacunar stroke syndromes, whose risk-factors are already managed.(CA).
Time frame: Data collected from enrolment to the end of the follow-up measurements at 4 weeks. Comparisons to other data and other studies to be done at analysis stage.
Efficiency of regulatory mechanisms will be analysed through measuring cerebral autoregulation.
Compare cerebral haemodynamics in lacunar stroke patients with older patients experiencing advanced chronic cerebrovascular disease with lacunar stroke syndromes, whose risk-factors are already managed. (VMR).
Time frame: Data collected from enrolment to the end of the follow-up measurements at 4 weeks. Comparisons to other data and other studies to be done at analysis stage.
Efficiency of regulatory mechanisms will be analysed through measuring vasomotor reactivity.
Compare cerebral haemodynamics in lacunar stroke patients with older patients experiencing advanced chronic cerebrovascular disease with lacunar stroke syndromes, whose risk-factors are already managed.(ARI).
Time frame: Data collected from enrolment to the end of the follow-up measurements at 4 weeks. Comparisons to other data and other studies to be done at analysis stage.
Efficiency of regulatory mechanisms will be analysed through measuring the autoregulatory index.
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 24 Mar 2025.
- Individual participant dataSharing planned: No. Individual patient data will not be shared, however once analysed and combined (statistically through mean averages etc), the results will be compiled into a report and submitted to a relevant journal, allowing researchers to view them.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lacunar Stroke, run by University of Leicester at 1 site in United Kingdom.
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 3 inclusion and 2 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 24 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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 Jatinder S Minhas, SFHEA (+44 116 252 3299, jm591@leicester.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cerebral blood velocity measurements before and after management of uncontrolled risk-factors in those diagnosed with lacunar stroke syndromes. (time frame: From enrolment to the end of the follow-up measurements at 4 weeks.). The study lists 7 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 24 Mar 2025.