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21 May 2012
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| [ ...Back to search results ] | [ Print-friendly version ] |
| How intensively should we treat blood PRESsure in established cERebral small VEssel disease? |
| ISRCTN | ISRCTN37694103 |
| ClinicalTrials.gov identifier | |
| Public title | How intensively should we treat blood PRESsure in established cERebral small VEssel disease? |
| Scientific title | Blood pressure treatment in small vessel disease |
| Acronym | PRESERVE |
| Serial number at source | 10962 |
| Study hypothesis |
Cerebral small vessel disease (SVD) accounts for about 20% of all stroke and is the major cause of vascular cognitive impairment and dementia. The major risk factor is hypertension but in patients with severe disease (with radiological changes of extensive white matter damage, which is called leukoaraiosis) we do not know how intensively we should treat blood pressure. In this clinical trial we will determine whether intensive, versus standard, treatment of blood pressure in hypertensive patients with SVD and radiological leukoaraiosis is associated with reduced cognitive decline.
In nested substudies we will: 1. Investigate if the type of treatment is associated with brain changes detectable on MRI imaging 2. Investigate if a treatment effect is seen in a reduced rate of white matter damage and/or an increase in blood flow in the brain seen in specific MRI techniques. In addition, we will use this substudy to compare the sensitivity of different types of MRI imaging in identifying white matter damage in the brain and also the relationship between white matter damage and cognitive decline. More details can be found at http://public.ukcrn.org.uk/Search/StudyDetail.aspx?StudyID=10962 |
| Lay summary | Lay summary under review 3 |
| Ethics approval | North London REC 3, 01 July 2011 ref: 11/LO/0458 |
| Study design | Randomised interventional treatment |
| Countries of recruitment | United Kingdom |
| Disease/condition/study domain | Dementias and Neurodegenerative Diseases |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 14/10/2011 |
| Anticipated end date | 01/07/2016 |
| Status of trial | Ongoing |
| Patient information material | http://www.preserve.sgul.ac.uk/study-documents |
| Target number of participants | UK Sample Size: 422 |
| Interventions | Participants are randomised to either Intensive or Standard blood pressure treatment. The intensive blood pressure lowering arm aims for a systolic blood pressure of less than 125mmHg. The standard blood pressure lowering arm aims for a systolic blood pressure of 130 to 140mmHg, as recommended by current guidelines. The trial is comparing 2 strategies for lowering blood pressure and not looking at specific blood pressure drugs. |
| Primary outcome measure(s) |
Main study:
Composite cognitive score, which is an overall score for the cognitive tests carried out at baseline, 12 months & 24 months. Structural DTI MRI sub-study: DTI white matter ultrastructure measured by MD and FA. All outcome measures for this sub-study are measured at baseline and 24 months Perfusion MRI sub-study: Cerebral blood flow, measured at baseline, 3 months and 24 months. |
| Secondary outcome measure(s) |
Main study:
1. Results of specific cognitive tests 2. Disability measures 3. Quality of life questionnaires 4. Blood pressure readings (taken at all visits) 5. Record of adverse events (taken at all visits) Measured at baseline, 12 months & 24 months Structural DTI MRI sub-study: Brain atrophy and White matter lesion volume measured on T2/FLAIR. All outcome measures for this sub-study are measured at baseline and 24 months |
| Sources of funding | The Stroke Association (UK) |
| Trial website | http://www.preserve.sgul.ac.uk |
| Publications | |
| Contact name | Ms Eithne Smith |
| Address |
Stroke and Dementia Research Centre
St. George's University of London Cranmer Terrace |
| City/town | London |
| Zip/Postcode | SW17 0RE |
| Country | United Kingdom |
| preserve@sgul.ac.uk | |
| Sponsor | St George's University of London (UK) |
| Address |
Joint Research and Enterprise Office
Cranmer Terrace |
| City/town | London |
| Zip/Postcode | SW17 0RE |
| Country | United Kingdom |
| Sponsor website: | http://www.sgul.ac.uk/ |
| Date applied | 25/01/2012 |
| Last edited | 26/01/2012 |
| Date ISRCTN assigned | 25/01/2012 |
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| © 2012 ISRCTN unless otherwise stated. | |
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