Intensive Blood Pressure Control in Ischaemic Stroke Patients With Severe Cerebral Small Vessel Disease

NCT05690997 | Unknown DMC

• 2 other identifiers: GL2021001UW21-128
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Small Vessel Cerebrovascular Disease; Stroke

Keywords

Stroke; Small Vessel Disease; Cerebral blood flow; Cognition; Elderly

Outcome Measures

Primary Outcomes (1)

• Cerebral Blood Flow

  Change in whole-brain CBF as measured using MRI ASL at end of study (1 year) compared to baseline.

  From Baseline to approximate 1 year after recruitment

Secondary Outcomes (6)

• Grey Matter - Cerebral Blood Flow

  From Baseline to approximate 1 year after recruitment

• White Matter - Cerebral Blood Flow

  From Baseline to approximate 1 year after recruitment

• Structural Connectivity

  From Baseline to approximate 1 year after recruitment

• Cognitive Function - MoCA

  From Baseline to approximate 1 year after recruitment

• Cognitive Function - Stroop colour-word test

  From Baseline to approximate 1 year after recruitment

Study Arms (2)

Intensive Treatment Group

OTHER

SBP target 120-129 mmHg

Other: Intensive treatment

Standard Treatment Group

OTHER

SBP target 130-140 mmHg

Other: Standard treatment

Interventions

Intensive treatment 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.

Intensive Treatment Group

Standard treatment 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.

Standard Treatment Group

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged ≥50
• Chinese ethnicity
• History of TIA/ischaemic stroke
• Underlying severe cerebral SVD as evidenced by brain MRI with total SVD score ≥3
• 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)
• Able to provide written informed consent
• Able to perform study cognitive assessments
• Modified Rankin Scale (mRS) ≤3
• Expected life expectancy \>2 years

You may not qualify if:

• Unable to, or unwilling to consent
• TIA/ischaemic stroke within three months (to avoid confounding effects of recovery on cognition from recent stroke)
• 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
• Cortical infarction \>2cm in diameter
• Paroxysmal or permanent atrial fibrillation
• Known single gene disorder causing cerebral SVD, e.g. cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (CADASIL)
• Symptomatic postural hypotension
• Moderate- and severe-stage dementia with Montreal Cognitive Assessment (MOCA)-HK score \<10
• Moderate and severe depressive symptoms with Patient Health Questionnaire-9 score ≥10
• Known secondary hypertension, e.g. hypertension is due to established obstructive sleep apnoea, renal parenchymal disease, renal artery stenosis, primary aldosteronism etc.
• Unable to complete cognitive assessments
• mRS \>3
• Life expectancy of less than 2 years

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

University of Hong Kong

Hong Kong, Hong Kong

RECRUITING

Related Publications (25)

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MeSH Terms

Conditions

Cerebral Small Vessel Diseases; Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Gary KK LAU

  The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gary KK LAU

CONTACT

852-22554249; gkklau@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 19, 2023
• Study Start: January 9, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: February 3, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)