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临床试验/NCT02537652
NCT02537652已完成不适用

Effect of Posture and Fasting State on Central and Peripheral Blood Pressure in Patients With Stroke

Hampshire Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
2
主要终点
Central blood pressure

研究概览

简要总结

Individuals who experience a stroke or transient ischaemic attack (TIA) are at heightened risk of subsequent vascular events, including heart attacks and secondary stroke/TIA. Blood pressure control is considered the most important contributor to positive health outcomes in stroke patients. The measurement of central blood pressure (cSBP) (the blood pressure which is being exerted at the heart), may provide clinicians with important diagnostic and prognostic information over and above that typically obtained from a peripheral blood pressure measure (the blood pressure in the arm). Central blood pressures may be better than traditional peripheral blood pressure measures as: i) peripheral blood pressure may not accurately reflect the effects of peak arterial blood pressure on centrally located organs, ii) central blood pressures may be 50 % superior to peripheral blood pressures when predicting cardiovascular events, and iii) information pertaining to central blood pressures may be more effective in the management of hypertension. While the validity of oscillometric devices which measure central blood pressures has been demonstrated, further study is required to determine precision under normal clinical operating conditions (i.e., reflective of the Hospital/GP practice setting). As such, this study will assess central and peripheral blood pressures of stroke patients when fasted and nonfasted, and when seated and supine. The study is interested in identifying the effect of the above parameters (fasted vs. unfasted, seated vs. supine) on central and peripheral blood pressures in stroke patients.

Participants will take part in three separate assessment sessions, on three separate days, with a minimum 24 hour recovery between each session. Each assessment is expected to last 90 minutes, with a minimum of eight blood pressures being taken from the left upper arm. As such, participants will be asked to give up 4.5 hours of their time to the study. During each assessment participants will be tested in a fasted and non-fasted state, and in a supine (lying) and seated position. All assessments will take place between 7 and 10am and will be undertaken following written informed consent.

详细描述

Stroke is a leading cause of death worldwide, and is a prominent cause of chronic disability, causing significant physical, cognitive and social impairment. In the United Kingdom, there are 150,000 strokes each year, with ~900,000 people living with the debilitating effects of stroke.Individuals who experience a stroke or transient ischaemic attack (TIA; minor stroke) are at heightened risk of experiencing vascular events in the future, such as myocardial infarction, stroke and secondary TIAs, and death. Of all the measures of interest, greater blood pressure control is the most important contributor to positive health outcomes in stroke patients. However, clinical practice, and research to date concentrate on the assessment of peripheral blood pressure assessments (the blood pressure as identified from the arm). The measurement of central haemodynamic parameters, including central systolic blood pressure (cSBP) and arterial wave reflection (i.e., augmentation index, AIx), hold the potential to provide clinicians with important diagnostic and prognostic information beyond that provided by traditional peripheral blood pressure readings. The assessment of central blood pressure is important as it reflects the stress and loading on the left ventricle and coronary arteries. Considering the marked differences in pulse pressure between the central aorta and peripheral limbs, peripheral blood pressure may not accurately reflect the effects of peak arterial blood pressure on centrally located organs. Previous research has demonstrated central blood pressures to be 50 % superior to peripheral blood pressures when predicting cardiovascular events, while in comparison to peripheral blood pressure, central blood pressure may improve the management of hypertension. Owing to recent technological advances, central haemodynamic parameters can be obtained quickly and noninvasively using an automated blood pressure cuff (oscillometer).While the validity of these devices which measure central haemodynamic parameters has been demonstrated, further study is required to determine measurement precision (reliability) under normal clinical operating conditions (i.e. , in the hospital or general practioner setting). As such, this study will assess the influence of fasting status (fasted vs. nonfasted) and posture (seated vs. supine) on central and peripheral blood pressure measures in patients diagnosed with stroke. The study will determine whether these parameters can be reliably assessed and whether stroke severity (major stroke, minor stroke, TIA) influences the reported results.

Design and setting:

This study is a single centre observational study. All stroke/TIA patients will be recruited from the Royal Hampshire County Hospital within the Hampshire Hospital NHS Foundation Trust (HHFT).

Patients will be recruited from the inpatient and outpatient setting. For patients diagnosed with a major or minor stroke and who have not been discharged from the hospital, recruitment will take place on the acute stroke ward at the hospital. For these patients, all assessments will also be undertaken within the hospital as patients will be based in the acute stroke ward. For those patients identified with minor stroke or TIA within the emergency department or outpatient setting (i.e., stroke clinics), and who not be staying in the acute stroke ward, will be recruited from these settings. All assessments with these patients will take place in the Physiology Laboratory at the University of Winchester. Written informed consent will be obtained from all participants.

All stroke (minor and major) patients will be assessed using the National Institute of Health Stroke Severity Scale (NIHSS). All patients with suspected TIA with be assessed with the ABCD2. Participants will comply with pharmacological treatment as recommended.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者

入选标准

  • Patients diagnosed with major stroke, minor stroke or TIA by a member of the clinical team.
  • Reside within the locality of the Hampshire Hospital's Foundation Trust
  • Patients are to be assessed within 8 weeks of their initial stroke/TIA diagnosis.
  • Do not meet exclusion criteria

排除标准

  • end of life stroke patients;
  • Unstable cardiac conditions
  • oxygen dependence
  • significant dementia; patients lacking capacity to consent to participate in study
  • unable to swallow
  • Patient is diagnosed with major stroke, minor stroke or TIA more than 8 weeks prior to an assessment

结局指标

主要结局

Central blood pressure

时间窗: 10 months

Central blood pressures will be assessed on three separate days in both a seated and supine posture when fasted and unfasted.

次要结局

  • Peripheral blood pressure(10 months)
  • Augmentation index(10 months)
  • Pulse pressure(10 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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