The Relationship Between Controlling Risk Factors and Cerebral Haemodynamics in Lacunar Stroke

NCT06354881 | Recruiting

• 2 other identifiers: 0967TM61008S3
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lacunar Stroke

Keywords

Lacunar; Stroke; Cerebral Autoregulation; Cerebral Blood Flow

Outcome Measures

Primary Outcomes (7)

• 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.

• 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.

Study Arms (1)

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.

Device: Transcranial Doppler Ultrasonography (TCD) during sit-stand manoeuvres

Interventions

Transcranial Doppler Ultrasonography (TCD) during sit-stand manoeuvres DEVICE

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.

Lacunar Stroke Syndrome Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants will be recruited from Leicester Royal Infirmary TIA clinic or stroke ward.

You may qualify if:

• Adults aged between 18-120 years.
• Diagnosis of lacunar stroke syndrome.
• New diagnosis or known diagnosis of hypertension and/or diabetes.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Leicester: lead
• British Heart Foundation: collaborator
• University Hospitals, Leicester: collaborator

Study Sites (1)

University Hospitals of Leicester NHS Trust

Leicester, Leicestershire, LE1 5WW, United Kingdom

RECRUITING

MeSH Terms

Conditions

Stroke, Lacunar; Stroke

Interventions

Ultrasonography, Doppler, Transcranial

Condition Hierarchy (Ancestors)

Cerebral Small Vessel Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Thrombotic Stroke; Ischemic Stroke; Vascular Diseases; Cardiovascular Diseases; Brain Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Echoencephalography; Neuroradiography; Neuroimaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiography; Ultrasonography; Ultrasonography, Doppler; Diagnostic Techniques, Neurological; Investigative Techniques

Central Study Contacts

Jatinder S Minhas, SFHEA

CONTACT

+44 116 252 3299; jm591@leicester.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: April 9, 2024
• Study Start: May 2, 2024
• Primary Completion: March 1, 2026
• Study Completion: March 1, 2026
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)