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临床试验/NCT06523062
NCT06523062尚未招募不适用

Short Term Reproducibility of Office White-coat Effect

University Hospital, Caen0 个研究点目标入组 922 人开始时间: 2024年9月1日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

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