NCT02663791

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,308

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 26, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

May 11, 2023

Status Verified

May 1, 2023

Enrollment Period

3 months

First QC Date

January 18, 2016

Last Update Submit

May 10, 2023

Conditions

Keywords

AlcoholAortic stiffnessArterial stiffnessPulse wave velocityLongitudinal

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Eligibility Criteria

Age34 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Data will be drawn from the Whitehall II cohort study database. This incorporates longitudinal assessments of 6,895 male (67%) and 3,413 female British civil servants, originally recruited between 1985 and 1988. The overall age range was 34 to 56 years. Of these, 897 were excluded due to having a history of cardiovascular disease. Clinical assessments were repeated at 4-to-5 year intervals. PWV measurement was introduced to the protocol at phase 9, with assessments taking place during 2008 and 2009. 3,869 of the sample participants had a successful PWV assessment during this time. Follow-up testing took place at phase 11, during 2012 and 2013. Of the participants who underwent a PWV assessment at phase 9, 3,130 also had a successful PWV assessment at phase 11. This group included 2,350 males (75%) and 780 females.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, WC1E 6BT, United Kingdom

Location

Related Publications (10)

  • Marmot M, Brunner E. Cohort Profile: the Whitehall II study. Int J Epidemiol. 2005 Apr;34(2):251-6. doi: 10.1093/ije/dyh372. Epub 2004 Dec 2. No abstract available.

    PMID: 15576467BACKGROUND
  • Cavalcante JL, Lima JA, Redheuil A, Al-Mallah MH. Aortic stiffness: current understanding and future directions. J Am Coll Cardiol. 2011 Apr 5;57(14):1511-22. doi: 10.1016/j.jacc.2010.12.017.

    PMID: 21453829BACKGROUND
  • Vlachopoulos C, Aznaouridis K, Stefanadis C. Prediction of cardiovascular events and all-cause mortality with arterial stiffness: a systematic review and meta-analysis. J Am Coll Cardiol. 2010 Mar 30;55(13):1318-27. doi: 10.1016/j.jacc.2009.10.061.

    PMID: 20338492BACKGROUND
  • Cecelja M, Chowienczyk P. Role of arterial stiffness in cardiovascular disease. JRSM Cardiovasc Dis. 2012 Jul 31;1(4):cvd.2012.012016. doi: 10.1258/cvd.2012.012016.

    PMID: 24175067BACKGROUND
  • Cecelja M, Chowienczyk P. Dissociation of aortic pulse wave velocity with risk factors for cardiovascular disease other than hypertension: a systematic review. Hypertension. 2009 Dec;54(6):1328-36. doi: 10.1161/HYPERTENSIONAHA.109.137653. Epub 2009 Nov 2.

    PMID: 19884567BACKGROUND
  • Matsumoto C, Tomiyama H, Yamada J, Yoshida M, Shiina K, Nagata M, Yamashina A. Association of blood pressure levels with the effects of alcohol intake on the vasculature in Japanese men. Hypertens Res. 2009 Feb;32(2):127-32. doi: 10.1038/hr.2008.23. Epub 2009 Jan 16.

    PMID: 19262471BACKGROUND
  • Beilin L. Alcohol and cardiovascular disease: possible protection via effects on aortic stiffness. J Hypertens. 2005 Apr;23(4):703-5. doi: 10.1097/01.hjh.0000163133.62020.98. No abstract available.

    PMID: 15775769BACKGROUND
  • Sasaki S, Yoshioka E, Saijo Y, Kita T, Okada E, Tamakoshi A, Kishi R. Relation between alcohol consumption and arterial stiffness: A cross-sectional study of middle-aged Japanese women and men. Alcohol. 2013 Dec;47(8):643-9. doi: 10.1016/j.alcohol.2013.10.003. Epub 2013 Oct 17.

    PMID: 24239150BACKGROUND
  • 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.

    PMID: 17000623BACKGROUND
  • O'Neill D, Britton A, Brunner EJ, Bell S. Twenty-Five-Year Alcohol Consumption Trajectories and Their Association With Arterial Aging: A Prospective Cohort Study. J Am Heart Assoc. 2017 Feb 20;6(2):e005288. doi: 10.1161/JAHA.116.005288.

Related Links

Study Officials

  • D O'Neill, PhD

    University College, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate

Study Record Dates

First Submitted

January 18, 2016

First Posted

January 26, 2016

Study Start

January 1, 2016

Primary Completion

April 1, 2016

Study Completion

June 1, 2016

Last Updated

May 11, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will share

Researchers can request access to anonymised data: http://www.ucl.ac.uk/whitehallII/data-sharing

Locations