Prevention of Hypertensive Injury to the Brain by Intensive Treatment in IntraCerebral Haemorrhage (PROHIBIT-ICH)

Summary

Participation Requirements

Description

About 112 eligible participants will be identified from primary care by a member of the research practitioner or member of research/clinical teams (patient identification sites) outpatient clinics (stroke clinics, neurology clinics, geriatric clinics, neurosurgical clinics) and from acute stroke uni...

About 112 eligible participants will be identified from primary care by a member of the research practitioner or member of research/clinical teams (patient identification sites) outpatient clinics (stroke clinics, neurology clinics, geriatric clinics, neurosurgical clinics) and from acute stroke units or high dependency units at participating hospitals. Patients may be under the care of stroke physicians, geriatricians, neurologists, or neurosurgeons. The Bluetooth telemetric home monitoring equipment will be provided either at hospital discharge or after hospital discharge and the equipment will be set up in the participant's home. Patients will be handed or sent a participant information leaflet. An opportunity to meet a member of the research team will be arranged in person by a member of the clinical care team or subsequently by phone by a member of the research team. All interested participants will have an opportunity to ask questions about the study and these will be answered by a member of the research team prior to enrolment. Consent: Participants will be asked to give written consent prior to participation, after a meeting with a researcher when any questions about the study will be answered. Baseline: At baseline, the following trial specific procedures will be carried out after consent as a requirement for the study to commence: Medical History recorded Blood pressure medication and dose recorded Blood pressure (BP) Blood test (Venepuncture) MRI Scan Cognitive functional change Assessment (Montreal Cognitive Assessment) Completion of the EQ-5D questionnaire - 24 hour ABPM When a person agrees to participate demographic, contact and medical history information necessary to conduct the study will be recorded. Each participant will be allocated a unique trial number. Relevant sections of medical notes and data collected during the study may be looked at by the researchers from regulatory authorities or from the NHS Trust, where it is relevant to the subject's participation in the trial. Randomisation: Patients will be randomized in a 1:1 group assignment ratio to intensive BP lowering (intervention group) or standard care (control group) using an on line randomization service (Sealed Envelope), available 24 hours a day. Intervention: The Telemetric Bluetooth home Blood Pressure-monitoring device will monitor participant's BP to keep the target of 120/80mm Hg, if this is not achievable then the BP medication will be adjusted accordingly in order to achieve a target of 120/80mm Hg at 3 months follow-up. BP readings (3 readings over 10-minutes in the seated position in the non dominant arm, unless hemiparesis) will be taken 3 times daily (early morning, early afternoon and evening). All BP data will be automatically transmitted centrally in real time to the device co-ordination site in Oxford. A dedicated research member will be responsible for checking all BP data daily on patients in the study, and will advise on adjusting medication according to a standard protocol based on the latest BHS guideline, to ensure that BP is lowered to the intervention arm target. The local study centre will send new prescriptions directly to patients (with communication simultaneously with the GP). For dose changes, advice will be given to participants by phone by the central study team. All medication changes will be notified to the local research team and GP? responsibility for BP treatment will be by the local PI. Follow up: 3 month Follow-up (Visit two): Completion of 3 month CRF, blood pressure recorded and completion of Modified Cognitive assessment, EQ-5D questionnaire and home blood pressure acceptability questionnaire. 24-hour ABPM to be performed at the time of the 3 month follow-up visit. 12 month follow-up (Final visit): Completion of 12 month CRF, blood pressure recorded, and completion of Cognitive assessment and EQ-5D questionnaire. 24-hour ABPM to be performed at the time of the 12 month follow-up visit. An MRI scan will be performed at baseline and the 12 month follow-up visit on all participants to identify markers of cerebral small vessel disease including: change in white matter hyperintensity volume change in white matter microstructure (DTI) change in the number of CMBs change in cerebral atrophy Primary outcomes: (a) BP study (i) Efficacy: the magnitude of difference in BP at 3 months in the intervention arm versus control arm compared with baseline measures (ii) Feasibility: consent rate? dropout rate from the intervention prior to 1 month? patient approval of the monitoring process (iii) Safety: serious adverse event related to reducing BP in intervention arm (b) Imaging study (i) Efficacy: the progression in MRI white matter hyperintensity (WMH) volume over 1 year Secondary outcomes: BP study: clinical outcomes including recurrent vascular events and cognition? number of BP lowering drugs at 3 months and at 1 year follow-up visits? mean daytime BP at 1 year on 24-hour ABPM Imaging study: neuroimaging outcomes including (but not limited to) the proportion of patients who develop new cerebral microbleeds (CMBs) over 1 year? number of new CMBs at 1 year? new infarcts or intracerebral haemorrhages at 1 year? change in mean diffusivity (MD), fractional anisotropy (FA) and other 3T DTI metrics? change in cerebral blood flow (CBF) on 3T PCASL? change in total brain volume, white matter volume and grey matter volume on 3T T1 volumetric images? composite neuroimaging measures (e.g summary SVD scores)

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