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Short Term Reproducibility of Office White-coat Effect

NCT06523062 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 922

Last updated 2024-07-26

No results posted yet for this study

Summary

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.

Conditions

  • White Coat Hypertension

Interventions

DEVICE

blood pressure measurement

automated blood pressure measurement on 3 occasions at each consultation, twice with one month apart

Sponsors & Collaborators

  • University Hospital, Caen

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2025-08-31
Completion
2025-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06523062 on ClinicalTrials.gov