Aortic Stiffness Clinical Trial
Verified date | May 2023 |
Source | University College, London |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Arterial stiffness is an important marker of cardiovascular health. Recent evidence from cross-sectional research has suggested it is associated with alcohol consumption. Research that employs a longitudinal perspective may be better equipped to evaluate the nature of this relationship and in particular to determine whether alcohol consumption is linked to the progression of arterial stiffness over time. The current study will consequently implement a longitudinal cohort design to evaluate the association between long-term alcohol consumption patterns and changes in arterial stiffness. Data will be drawn from the Whitehall II cohort study of British civil servants, in which participants completed repeat pulse wave velocity (PWV) assessments of arterial stiffness across a four-to-five year interval. Repeat measurements of volume of alcohol intake were also recorded for participants, extending back across more than two decades. Intake will be categorised in such a way as to distinguish between different alcohol consumer types, including non-drinkers and former drinkers. Linear mixed effects models will be used with adjustment for potential confounds, such as age, diabetes, mean arterial pressure and heart rate. Results from the modelling work will illustrate the extent and form of the association between alcohol intake and PWV. This work will provide useful insights into the role that alcohol intake plays in the longitudinal progression of an important cardiac marker, and it will have implications for our understanding of alcohol's relationship to cardiovascular health in the general population.
Status | Completed |
Enrollment | 10308 |
Est. completion date | June 2016 |
Est. primary completion date | April 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 34 Years to 100 Years |
Eligibility | Inclusion Criteria: - Participated in Whitehall II cohort study - Reported alcohol consumption on a minimum of one occasion between phase 1 and phase 9 of the Whitehall II cohort study Exclusion Criteria: - Left Whitehall II cohort study prior to phase 9 or did not participate in PWV assessment at Phase 9 - Had history of coronary heart disease |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University College London | London |
Lead Sponsor | Collaborator |
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University College, London | Alcohol Research UK, Medical Research Council |
United Kingdom,
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Laurent S, Cockcroft J, Van Bortel L, Boutouyrie P, Giannattasio C, Hayoz D, Pannier B, Vlachopoulos C, Wilkinson I, Struijker-Boudier H; European Network for Non-invasive Investigation of Large Arteries. Expert consensus document on arterial stiffness: methodological issues and clinical applications. Eur Heart J. 2006 Nov;27(21):2588-605. doi: 10.1093/eurheartj/ehl254. Epub 2006 Sep 25. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Baseline Carotid-Femoral Pulse Wave Velocity | A baseline carotid-femoral pulse wave velocity (PWV) assessment occurred at phase 9 (each participant attended an assessment day during 2008 or 2009) of the Whitehall II cohort study. Up to 3 PWV measurements were performed during this assessment, and where a participant underwent multiple measurements, the mean of these will be calculated for that participant and used as their baseline PWV measurement. | 1 day | |
Primary | Change from Baseline Carotid-Femoral Pulse Wave Velocity at Follow-Up | Change in carotid-femoral PWV between the baseline and follow-up PWV assessments will be investigated. The follow-up PWV assessment occurred at phase 11 (2012-2013) of the Whitehall II cohort study. Up to 3 PWV measurements were again performed during this assessment, and where a participant underwent multiple measurements, the mean of these will be calculated for that participant and used as their follow-up PWV measurement. | 4 to 5 years |
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