Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05690997
Status:
RECRUITING
Last Update Posted:
2023-02-03
First Post:
2023-01-10
Brief Title:
Intensive Blood Pressure Control in Ischaemic Stroke Patients With Severe Cerebral Small Vessel Disease
Sponsor:
The University of Hong Kong
Organization:
The University of Hong Kong
Study Overview
Official Title:
Effect of Intensive Blood Pressure Control on Cerebral Blood Flow and Cognition in Ischaemic Stroke Patients With Severe Cerebral Small Vessel Disease
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 11 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 11 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
Detailed Description:
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 TIAischaemic 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 trials 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 eg ACEis ARBs thiazide diuretics and spironolactone
Chinese patients aged 50 with a prior history of TIAischaemic 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 trials 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 eg ACEis ARBs thiazide diuretics and spironolactone
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UW21-128 | OTHER | HKUHA HKW IRB | None |