Intensive Blood Pressure Control in Ischaemic Stroke Patients With Severe Cerebral Small Vessel Disease
NCT ID: NCT05690997
Last Updated: 2023-02-03
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
UNKNOWN
Clinical Phase
NA
Total Enrollment
104 participants
Study Classification
INTERVENTIONAL
Study Start Date
2023-01-09
Study Completion Date
2025-06-30
Brief Summary
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Objectives: Cerebral small vessel disease (SVD) is a common disease in patients with ischemic stroke and the most common cause of vascular dementia. Blood pressure (BP)-lowering is generally considered neuroprotective. Nevertheless, in patients with severe SVD burden, the optimal BP target is uncertain.
Hypothesis: BP-lowering to a systolic BP of 120-129mmHg in ischemic stroke patients with severe SVD is not associated with impaired cerebral perfusion, nor does it associate with worsening of structural connectivity and cognitive function.
Design and subjects: One-year trial where patients aged ≥50 with a history of ischaemic stroke and severe cerebral SVD will be randomised (1:1) to a systolic BP target of 120-129mmHg versus 130-140mmHg.
Study instruments: At baseline and one-year, all subjects will receive a brain magnetic resonance imaging (MRI) to evaluate their cerebral blood flow (CBF) and white matter integrity. They will also receive neuropsychological batteries to evaluate cognitive functioning. In addition, subjects will receive home BP monitoring with periodic medication changes prescribed by medical doctor to ensure the target BP is achieved.
Main outcome measures: Primary end-point is the change in CBF. Secondary end-points include changes in structural connectivity and cognitive performance.
Hypothesis: BP-lowering to a systolic BP of 120-129mmHg in ischemic stroke patients with severe SVD is not associated with impaired cerebral perfusion, nor does it associate with worsening of structural connectivity and cognitive function.
Design and subjects: One-year trial where patients aged ≥50 with a history of ischaemic stroke and severe cerebral SVD will be randomised (1:1) to a systolic BP target of 120-129mmHg versus 130-140mmHg.
Study instruments: At baseline and one-year, all subjects will receive a brain magnetic resonance imaging (MRI) to evaluate their cerebral blood flow (CBF) and white matter integrity. They will also receive neuropsychological batteries to evaluate cognitive functioning. In addition, subjects will receive home BP monitoring with periodic medication changes prescribed by medical doctor to ensure the target BP is achieved.
Main outcome measures: Primary end-point is the change in CBF. Secondary end-points include changes in structural connectivity and cognitive performance.
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Detailed Description
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Cerebral small vessel disease (SVD) is a common disease in patients with ischemic stroke and the most common cause of vascular dementia. The global burden of cerebral SVD is high and strategies to better prevent and manage cerebral SVD is urgently needed. Whilst blood pressure (BP) lowering is considered neuroprotective in patients with cerebral SVD, the optimal BP target in ischaemic stroke patients with severe SVD remains uncertain. Therefore, this randomised clinical trial aims to investigate whether two selected systolic blood pressure targets \[systolic BP (SBP) 120-129mmHg versus 130-140mmHg\] have different effects on cerebral blood flow and white matter integrity (structural connectivity) detected by magnetic resonance imaging (MRI) of the brain, as well as on cognition, over a one-year intervention period.
Chinese patients aged ≥50 with a prior history of TIA/ischaemic stroke fitting the inclusion and exclusion criteria will be recruited. At baseline, recruited subjects will undergo clinical and cognitive assessments. Blood pressure will be measured at clinic with an automated BP measurement system. A baseline non-contrast MRI of the brain will be arranged. The non-contrast MRI and cognitive assessments will be repeated at approximately 1 year after recruitment into the study.
To ensure consistency, our trial's antihypertensive strategy and titration shall align with those recommended by international guidelines. Blood tests for renal function will be arranged after modifying the prescription of specific anti-hypertensive agents (e.g. ACEis, ARBs, thiazide diuretics and spironolactone).
Chinese patients aged ≥50 with a prior history of TIA/ischaemic stroke fitting the inclusion and exclusion criteria will be recruited. At baseline, recruited subjects will undergo clinical and cognitive assessments. Blood pressure will be measured at clinic with an automated BP measurement system. A baseline non-contrast MRI of the brain will be arranged. The non-contrast MRI and cognitive assessments will be repeated at approximately 1 year after recruitment into the study.
To ensure consistency, our trial's antihypertensive strategy and titration shall align with those recommended by international guidelines. Blood tests for renal function will be arranged after modifying the prescription of specific anti-hypertensive agents (e.g. ACEis, ARBs, thiazide diuretics and spironolactone).
Conditions
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Small Vessel Cerebrovascular Disease
Stroke
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Intensive treatment group:
if the mean home SBP preceding clinic follow-up is \>130mmHg, BP lowering treatment will be stepped up, and if the mean SBP preceding clinic follow-up is \<120mmHg, BP lowering treatment will be stepped down, until the target SBP of 120-129mmHg is achieved, or symptoms of hypotension prevent treatment to be further intensified.
Standard treatment group:
if the mean home SBP preceding clinic follow-up is \>140mmHg, BP lowering treatment will be stepped up, and if the mean SBP preceding clinic follow-up is \<130mmHg, BP lowering will be stepped down, until the target SBP 130-140mmg is achieved or symptoms of hypotension prevent treatment being intensified.
if the mean home SBP preceding clinic follow-up is \>130mmHg, BP lowering treatment will be stepped up, and if the mean SBP preceding clinic follow-up is \<120mmHg, BP lowering treatment will be stepped down, until the target SBP of 120-129mmHg is achieved, or symptoms of hypotension prevent treatment to be further intensified.
Standard treatment group:
if the mean home SBP preceding clinic follow-up is \>140mmHg, BP lowering treatment will be stepped up, and if the mean SBP preceding clinic follow-up is \<130mmHg, BP lowering will be stepped down, until the target SBP 130-140mmg is achieved or symptoms of hypotension prevent treatment being intensified.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
To avoid bias in outcome assessment, evaluation of the primary and secondary outcome measures will be performed by a group who is independent from the clinical investigators and who will be blinded from all clinical, cognitive and radiological assessments.
Study Groups
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Intensive Treatment Group
SBP target 120-129 mmHg
Group Type
OTHER
Intensive treatment
Intervention Type
OTHER
If the mean home SBP preceding clinic follow-up is \>130mmHg, BP lowering treatment will be stepped up, and if the mean SBP preceding clinic follow-up is \<120mmHg, BP lowering treatment will be stepped down, until the target SBP of 120-129mmHg is achieved, or symptoms of hypotension prevent treatment to be further intensified.
Standard Treatment Group
SBP target 130-140 mmHg
Group Type
OTHER
Standard treatment
Intervention Type
OTHER
If the mean home SBP preceding clinic follow-up is \>140mmHg, BP lowering treatment will be stepped up, and if the mean SBP preceding clinic follow-up is \<130mmHg, BP lowering will be stepped down, until the target SBP 130-140mmg is achieved or symptoms of hypotension prevent treatment being intensified.
Interventions
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Intensive treatment
If the mean home SBP preceding clinic follow-up is \>130mmHg, BP lowering treatment will be stepped up, and if the mean SBP preceding clinic follow-up is \<120mmHg, BP lowering treatment will be stepped down, until the target SBP of 120-129mmHg is achieved, or symptoms of hypotension prevent treatment to be further intensified.
Intervention Type
OTHER
Standard treatment
If the mean home SBP preceding clinic follow-up is \>140mmHg, BP lowering treatment will be stepped up, and if the mean SBP preceding clinic follow-up is \<130mmHg, BP lowering will be stepped down, until the target SBP 130-140mmg is achieved or symptoms of hypotension prevent treatment being intensified.
Intervention Type
OTHER
Eligibility Criteria
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Inclusion Criteria
1. Aged ≥50
2. Chinese ethnicity
3. History of TIA/ischaemic stroke
4. Underlying severe cerebral SVD as evidenced by brain MRI with total SVD score ≥3
5. Underlying hypertension (defined as either SBP \>140mmHg and taking no more than two anti-hypertensive agents, or SBP between 130-140mmHg and on at least one and not more than three anti-hypertensive agents)
6. Able to provide written informed consent
7. Able to perform study cognitive assessments
8. Modified Rankin Scale (mRS) ≤3
9. Expected life expectancy \>2 years
2. Chinese ethnicity
3. History of TIA/ischaemic stroke
4. Underlying severe cerebral SVD as evidenced by brain MRI with total SVD score ≥3
5. Underlying hypertension (defined as either SBP \>140mmHg and taking no more than two anti-hypertensive agents, or SBP between 130-140mmHg and on at least one and not more than three anti-hypertensive agents)
6. Able to provide written informed consent
7. Able to perform study cognitive assessments
8. Modified Rankin Scale (mRS) ≤3
9. Expected life expectancy \>2 years
Exclusion Criteria
1. Unable to, or unwilling to consent
2. TIA/ischaemic stroke within three months (to avoid confounding effects of recovery on cognition from recent stroke)
3. Brain MR angiogram showing significant symptomatic or asymptomatic carotid, vertebral or intracranial large artery stenosis ≥50% as measured using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria
4. Cortical infarction \>2cm in diameter
5. Paroxysmal or permanent atrial fibrillation
6. Known single gene disorder causing cerebral SVD, e.g. cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL)
7. Symptomatic postural hypotension
8. Moderate- and severe-stage dementia with Montreal Cognitive Assessment (MOCA)-HK score \<10
9. Moderate and severe depressive symptoms with Patient Health Questionnaire-9 score ≥10
10. Known secondary hypertension, e.g. hypertension is due to established obstructive sleep apnoea, renal parenchymal disease, renal artery stenosis, primary aldosteronism etc.
11. Unable to complete cognitive assessments
12. mRS \>3
13. Life expectancy of less than 2 years
2. TIA/ischaemic stroke within three months (to avoid confounding effects of recovery on cognition from recent stroke)
3. Brain MR angiogram showing significant symptomatic or asymptomatic carotid, vertebral or intracranial large artery stenosis ≥50% as measured using the North American Symptomatic Carotid Endarterectomy Trial (NASCET) criteria
4. Cortical infarction \>2cm in diameter
5. Paroxysmal or permanent atrial fibrillation
6. Known single gene disorder causing cerebral SVD, e.g. cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL)
7. Symptomatic postural hypotension
8. Moderate- and severe-stage dementia with Montreal Cognitive Assessment (MOCA)-HK score \<10
9. Moderate and severe depressive symptoms with Patient Health Questionnaire-9 score ≥10
10. Known secondary hypertension, e.g. hypertension is due to established obstructive sleep apnoea, renal parenchymal disease, renal artery stenosis, primary aldosteronism etc.
11. Unable to complete cognitive assessments
12. mRS \>3
13. Life expectancy of less than 2 years
Minimum Eligible Age
50 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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The University of Hong Kong
OTHER
Sponsor Role
lead
Responsible Party
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Dr. Gary Kui Kai LAU
Clinical Associate Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Gary KK LAU
Role: PRINCIPAL_INVESTIGATOR
The University of Hong Kong
Locations
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University of Hong Kong
Hong Kong, , Hong Kong
Site Status
RECRUITING
Countries
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Hong Kong
Central Contacts
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Facility Contacts
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References
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Other Identifiers
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UW21-128
Identifier Type: OTHER
Identifier Source: secondary_id
GL2021001
Identifier Type: -
Identifier Source: org_study_id
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