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

Conditions

Dementias and Neurodegenerative Diseases Mental and Behavioural Disorders Unspecified dementia

Chris Patrick Pflanz, Marco Egle, John T. O’Brien, Robin G. Morris, Thomas R. Barrick et al. (10 authors)

Neurology2022-08-1710 citations

10.1212/wnl.0000000000201018

PRESERVE: Randomized Trial of Intensive Versus Standard Blood Pressure Control in Small Vessel Disease

Hugh S. Markus, Marco Egle, Iain D. Croall, Hasan Sari, Usman Khan et al. (38 authors)

Stroke2021-05-2832 citations

10.1161/strokeaha.120.032054

Effect of Standard vs Intensive Blood Pressure Control on Cerebral Blood Flow in Small Vessel Disease

Iain D. Croall, Daniel J. Tozer, Barry Moynihan, Usman Khan, John T. O’Brien et al. (12 authors)

JAMA Neurology2018-03-0589 citations

10.1001/jamaneurol.2017.5153

Prevention of Decline in Cognition after Stroke Trial (PODCAST): a study protocol for a factorial randomised controlled trial of intensive versus guideline lowering of blood pressure and lipids.

Blackburn DJ, Krishnan K, Fox L, Ballard C, Burns A, Ford GA, Mant J, Passmore P, Pocock S, Reckless J, Sprigg N, Stewart R, Wardlaw J, Bath PM.

2013-11-2214 citations

10.1186/1745-6215-14-401

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 b

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Clinical evidence of cerebral small vessel disease with MRI evidence of lacunar infarcts(s) (=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 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

Exclusion criteria: 1. Unable or unwilling to conset 2. Women of childbearingage 3. Minimental state examination (MMSE) 2 cm maximum diamete) 8. Symptomatic carotid stenosis or vertebral stenosis >70% as measured on NASCET criteria

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed