ISRCTN23416732已完成未知
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 个研究点目标入组 86 人开始时间: 2019年3月18日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 86
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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)
- •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. For patients recruited in hospital there should be a plan for home discharge (not to a nursing or care home) after their inpatient stay, or living at home at the time of recruitment
- •5. Willingness and demonstration of ability to undertake home BP measurements, either unassisted or with the help of a relative, friend or carer
- •6. Ability and willingness to complete an MRI scan
- •7. Ability and willingness to attend and complete the study assessments including cognitive screen
- •8. 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)
排除标准
- •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
- •11. Known sensitivity or contra-indication to BP treatments (e.g. symptomatic postural hypotension) is not an absolute exclusion criterion, but more information must be provided
- •12. Note that participation in other CTIMP or device trial is NOT an automatic exclusion criterion
研究者
相似试验
招募中
不适用
Induced hypertension for delayed cerebral ischaemia after aneurysmal subarachnoid haemorrhage: a feasibility studyintra-cerebral haemorrhagebrain haemorrhage10007963NL-OMON35291niversitair Medisch Centrum Utrecht24
进行中（未招募）
不适用
Prevention for Recurrence Of The preEClampsia with TAdalafilJPRN-jRCTs041180121Tanaka Hiroaki20
招募中
不适用
A study on Prevention of Hypertensive Disorders of Pregnancy who have a history of severe hypertensive disorders of pregnancy -Pre-test for multi center trialHypertensive Disorders of PregnancyJPRN-UMIN000027270Mie university hospital, Department of Obstetrics and Gynecology20
招募中
不适用
The dynamic effects of hypertension on the brain and its vesselsHigh bloodpressure1000796310057166HypertensionNL-OMON45503niversitair Medisch Centrum Utrecht200
进行中（未招募）
1 期
Prevention of Stroke in Survivors of Brain Bleeding with Atrial FibrillatioEUCTR2018-002176-41-ITImperial College of Science, Technology and Medicine654