The Relationship Between Controlling Risk Factors and Cerebral Haemodynamics in Lacunar Stroke
ConditionLacunar Stroke
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Leicester
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Adults aged between 18-120 years.
Diagnosis of lacunar stroke syndrome.
New diagnosis or known diagnosis of hypertension and/or diabetes.
Disqualifiers
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 population
The participants will be recruited from Leicester Royal Infirmary TIA clinic or stroke ward.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Transcranial Doppler Ultrasonography (TCD) during sit-stand manoeuvres
DeviceTCD 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.
Treatment groups
75 Participants
are divided into 1 treatment groupGroup A: Lacunar Stroke Syndrome Patients1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrolment to the end of the follow-up measurements at 4 weeks.2
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.
Time frame
From enrolment to the end of the follow-up measurements at 4 weeks.3
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.
Time frame
From enrolment to the end of the follow-up measurements at 4 weeks.4
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.
Time frame
From enrolment to the end of the follow-up measurements at 4 weeks.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Leicester
Lead sponsor
British Heart Foundation
Collaborator
University Hospitals, Leicester
Collaborator
Source ClinicalTrials.gov