Comparison of Blood Pressure Measurement With an Omron HEM-907 Device in a Clinical Setting and a Research Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Mean automated office blood pressure systolic blood pressure estimates
研究概览
简要总结
Automated office blood pressure (AOBP) devices are recommended for high blood pressure diagnosis. One of those devices is the Omron HEM-907 (Omron Healthcare). It is currently not known if blood pressure measurements performed with this device in a clinical setting are equivalent to those made in a research setting. Therefore, this randomized-controlled trial was designed. It aims to compare the blood pressure measurements performed in a clinical and a research setting. Seventy patients will be included and randomized to a clinical/research or research/clinical sequence.
详细描述
Hypertension is a common condition, with an estimated prevalence around 20 percent in Canada. It is a major risk factor for cardiovascular disease. Recently, Hypertension Canada has updated its guidelines and recommend we should consider a 120 mm Hg systolic blood pressure target in high-risk patients aged 50 years or older. This recommendation derives mainly from the SPRINT trial. In this trial, blood pressure was measured with an automated oscillometric blood pressure (AOBP) device, the Omron HEM-907 (Omron Healthcare). However, it is not known if measurements performed with this device in a clinical setting are equivalent to those made in a research setting. Therefore, this randomized-controlled trial was designed. It aims to compare the blood pressure measurements of 70 patients in a clinical and a research setting. Patients will be randomized to a clinical/research or a research/clinical sequence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years old
- •Hypertensive or presumed hypertensive
- •Patients with a scheduled visit at the IRCM hypertension clinic.
排除标准
- •Limitation preventing the measurement of blood pressure
- •Introduction or withdrawal of any blood pressure-modifying medication starting 4 weeks before the first and until the last study visit.
- •Recreative drug use (except cannabis)
- •Alcohol use of more than 4 drinks during the day
- •New symptoms during the research visit, that warrants a medical evaluation
- •Mean systolic blood pressure >180 mm Hg or mean diastolic blood pressure >110 mm Hg (using AOBP)
结局指标
主要结局
Mean automated office blood pressure systolic blood pressure estimates
时间窗: Up to 2 weeks
次要结局
- Mean automated office blood pressure diastolic blood pressure estimates.(Up to 2 weeks)
- Individual unaveraged automated office systolic and diastolic blood pressure measurements (1, 2 and 3)(Up to 2 weeks)
研究者
Maxime Lamarre-Cliche
MD
Institut de Recherches Cliniques de Montreal