Prevention Of Hypertensive Injury to the Brain by Intensive Treatment after IntraCerebral Haemorrhage: a pilot randomised trial of home telemetry-guided treatment

niversity College London0 sites86 target enrollmentMarch 18, 2019

ConditionsSpontaneous intracerebral haemorrhage (ICH)Circulatory System Intracerebral haemorrhage

Overview

Phase: 未知
Intervention: Not specified
Conditions: Spontaneous intracerebral haemorrhage (ICH)
Sponsor: niversity College London
Enrollment: 86
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 18, 2019

End Date

January 31, 2023

Last Updated

2 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

niversity College London

Eligibility Criteria

Inclusion Criteria

•Current participant inclusion criteria as of 18/04/2020:
•1\. Adults (aged \=30 years) with spontaneous primary ICH (i.e. without known underlying structural, macrovascular or other cause (e.g. arteriovenous malformation, tumour) after adequate investigation at the discretion of the local investigator). This will include participants presumed to have cerebral SVD (both hypertensive arteriopathy and cerebral amyloid angiopathy)
•2\. Clinical team opinion that BP control since the ICH is not adequate AND the measured SBP prior to randomisation is \=130 mm Hg
•3\. Recruitment soon after ICH, ideally at hospital discharge or within weeks, is encouraged; recruitment at a later stage after ICH is also exceptionally allowed if there is evidence of inadequate BP control AND SBP at randomisation is \=130 mm Hg
•4\. Willingness and demonstration of ability to undertake home BP measurements, either unassisted or with the help of a relative, friend or carer
•5\. Ability and willingness to complete an MRI scan
•6\. Ability and willingness to attend and complete the study assessments including cognitive screen
•7\. Ability and willingness to provide informed consent, or with a suitable consultee available and able to participate in the intervention (e.g. with a motivated carer)
•Previous participant inclusion criteria:
•1\. Adults (aged \=40 years) with spontaneous primary ICH (i.e. without known underlying structural, macrovascular or other cause (e.g. arteriovenous malformation, tumour) after adequate investigation at the discretion of the local investigator). This will include participants presumed to have cerebral SVD (both hypertensive arteriopathy and cerebral amyloid angiopathy)

Exclusion Criteria

•1\. Inability to provide informed consent or lack of suitable consultee (if unable to provide personal consent, lack of suitable consultee)
•2\. Evidence of a macrovascular or structural cause for ICH (e.g. AVM or tumour)
•3\. Diagnosis of dementia (DSM IV criteria, or self\-reported or documented in medical records)
•4\. Low Functional status (MRS \=4\) before or after ICH or frailty likely to make participation in 1\-year follow\-up difficult for the participant
•5\. Life expectancy \<2 years
•6\. Taking more than 2 BP\-lowering medications (i.e. 3 or more) at the time of consent
•7\. Consistently good BP control (below 130/80 mm Hg on measures taken as part of routine clinical care) prior to planned recruitment, judged not to require more intensive treatment
•8\. Known flow\-restricting intracranial/extracranial large arterial stenosis
•9\. Known contraindication to MRI
•10\. Known absence of mobile phone coverage from all network operators and home internet at the participant’s home