Intensive blood pressure control for stroke patients with severe small vessel disease
Effect of Intensive Blood Pressure Control on Cerebral Blood Flow and Cognition in Ischaemic Stroke Patients With Severe Cerebral Small Vessel Disease
This study is testing whether aiming for lower blood pressure targets can help older stroke patients with small vessel disease maintain better brain function and blood flow.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05690997 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of two different systolic blood pressure targets (120-129 mmHg versus 130-140 mmHg) on cerebral blood flow and cognitive function in patients aged 50 and older who have experienced ischemic stroke and have severe cerebral small vessel disease. Participants will undergo brain MRI and cognitive assessments at baseline and after one year to evaluate changes in brain structure and function. The study aims to determine the optimal blood pressure target that does not impair cerebral perfusion or cognitive abilities.
Who should consider this trial
Good fit: Ideal candidates are Chinese patients aged 50 and older with a history of ischemic stroke and severe cerebral small vessel disease.
Not a fit: Patients who have had a recent stroke within three months or those with significant large artery stenosis may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimal blood pressure management for stroke patients, potentially improving cognitive outcomes and quality of life.
How similar studies have performed: While blood pressure management in stroke patients has been studied, this specific approach targeting severe small vessel disease is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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
Where this trial is running
Hong Kong
- University of Hong Kong — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Gary KK LAU — The University of Hong Kong
- Study coordinator: Gary KK LAU
- Email: gkklau@hku.hk
- Phone: 852-22554249
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.