How intensively should we treat blood PRESsure in established cERebral small VEssel disease?

Not Applicable

Completed

• Conditions: Dementias and Neurodegenerative Diseases; Mental and Behavioural Disorders; Unspecified dementia

• Registration Number: ISRCTN37694103
• Lead Sponsor: St George's University of London (UK)

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29507944 2021 results in https://pubmed.ncbi.nlm.nih.gov/34044580/ (added 01/06/2021)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-01-25
• Study Completion: 2016-07-01
• Last Update Posted: 14 June 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 422

Inclusion Criteria

1. Clinical evidence of cerebral small vessel disease with MRI evidence of lacunar infarcts(s) (<=1.5cm maximum diameter) and confluent leukoaraiosis (defined on Fazekas scale as >=grade 2)
2. Clinical evidence of cerebral small vessel disease is defined as:

a.Lacunar stroke syndrome with symptoms lasting >24 hours

3. Transient ischaemic attack lasting < 24 hours with limb weakness, hemisensory loss or dysarthria AND with MR DWI imaging performed acutely showing lacunar infarction, or if MRI is not performed acutely (>2 weeks after TIA) with a lacunar infarction in an anatomically appropriate position on MRI

4. Vascular cognitive impairment with MRI shoing no evidence of hippocampal atrophy
5. Systolic BP > 140 mmHg
6. Taking no more than two BP lowering drugs at assessed for study participation.
7. Aged 40 years or over
8. Not diagnosed with dementia and Minimental state examination (MMSE) 21
9. Able and willing to consen
10. Expected life expectancy > 2 years
11. Able to perform study cognitive assessment

Exclusion Criteria

1. Unable or unwilling to conset
2. Women of childbearingage
3. Minimental state examination (MMSE) <21 or diagnosis of dementia on Diagnostic and Statistical Manual of Mental Disorders (DSM IV) criteria
4. Life expectancy less than 2 years
5. Symptomatic postural hypotension
6. Known single gene disorder causing small vessel disease (eg CADASI)
7. Cortical infarction (>2 cm maximum diamete)
8. Symptomatic carotid stenosis or vertebral stenosis >70% as measured on NASCET criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Main study:<br> Composite cognitive score, which is an overall score for the cognitive tests carried out at baseline, 12 months & 24 months.<br><br> Structural DTI MRI sub-study:<br> DTI white matter ultrastructure measured by MD and FA.<br> All outcome measures for this sub-study are measured at baseline and 24 months<br><br> Perfusion MRI sub-study:<br> Cerebral blood flow, measured at baseline, 3 months and 24 months.<br>

Secondary Outcome Measures

Name	Time	Method
<br> Main study:<br> 1. Results of specific cognitive tests<br> 2. Disability measures<br> 3. Quality of life questionnaires<br> 4. Blood pressure readings (taken at all visits)<br> 5. Record of adverse events (taken at all visits)<br> Measured at baseline, 12 months & 24 months<br><br> Structural DTI MRI sub-study:<br> Brain atrophy and White matter lesion volume measured on T2/FLAIR.<br> All outcome measures for this sub-study are measured at baseline and 24 months<br>