Short Term Reproducibility of Office White-coat Effect
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 922
- 主要终点
- OWCET
研究概览
简要总结
While a theoretical increase in systolic blood pressure (BP) of 10 mmHg can triple the relative risk of cardiovascular disease (CVD), the potential presence of a white coat effect (WCE) can interfere with the assessment of blood pressure control in the consultation. However, it is often difficult to assess the presence of a white coat effect (a quantitative variable) in general practice because of the difficulties in performing ambulatory BP measurements (self-measurement of blood pressure or ambulatory BP measurements). We have therefore previously described a surrogate concept of WCE obtained during a consultation with a general practitioner. It corresponds to a reduction of 10mmHg or more in systolic BP between the start and the end of the consultation. We have named it 'office white coat effect tail' (OWCET) and we have shown that OWCET, as a dichotomous variable, in a large Italian population cohort, with a follow-up of more than 18 years, was associated with an excess incidence of stroke, myocardial infarction (MI) and CVD and with excess mortality from MI and CVD. This concept appears to be more prevalent in women and is independent of blood pressure variability (regression to the mean). In addition, there is a genuine correlation between WCE and OWCET. To our knowledge, the reproducibility of the OWCET has never been studied, which could distort the relevance of this concept in the context of cardiovascular risk stratification in primary care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
盲法说明
adults > 18 y
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adult patients ;
- •not taking any antihypertensive medication;
- •free of any cardiovascular pathology.
排除标准
- •patients who are minors or protected adults ;
- •patients with BP ≥160/105 mmHg;
- •history of secondary hypertension;
- •taking a treatment that may affect blood pressure.
结局指标
主要结局
OWCET
时间窗: 1 month
Measurement of OWCET on two occasions during two consultations separated by one month, using the same automated blood pressure monitor, in order to estimate an intraclass kappa coefficient (qualitative measurement).
次要结局
- Factors associated with reproducibility of OWCET(1 month)
- Different definitions of OWCET(1 month)
- blood pressure Variability(1 month)
