LACUNAR_CA
Understanding the Relationship Between Controlling Risk Factors and Cerebral Haemodynamic Changes in Lacunar Stroke, and Its Interaction With Ageing
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · British Heart Foundation
observational
75
1 country
1
Study Start
May 2, 2024
Actual (reported)Primary Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 19, 2024
Actual (reported)April 9, 2024
Actual (reported)May 2, 2024
Actual (reported)March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
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.
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.
From enrolment to the end of the follow-up measurements at 4 weeks.
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The participants will be recruited from Leicester Royal Infirmary TIA clinic or stroke ward.
University Hospitals of Leicester NHS Trust
Leicester, Leicestershire, LE1 5WW, United Kingdom
First Submitted
March 19, 2024
First Posted
April 9, 2024
Study Start
May 2, 2024
Actual (reported)Primary Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
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.
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.
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.
Contact the study team to confirm eligibility.
Study Completion
March 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
March 24, 2025
Record last verified: 2025-03
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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Source: ClinicalTrials.gov.
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