Ignite Creation Date:
2024-10-25 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06523062
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-22
Brief Title:
Short Term Reproducibility of Office White-coat Effect
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Short Term Reproducibility of Office White-coat Effect
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REBBRE
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None