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NCT03133689 Clinical Trial

Alcohol Consumption and Coronary Heart Disease Onset

Coronary Heart Disease Clinical Trial

Official title:
Alcohol Consumption and Time-to-onset for Coronary Heart Disease: An Individual Participant Data Meta-analysis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03133689
Other study ID # UCLAlcoholLifecourse_CHDStudy
Secondary ID
Status Completed
Phase N/A
First received April 26, 2017
Last updated December 21, 2017
Start date March 1, 2017
Est. completion date December 12, 2017

Study information
Verified date April 2017
Source University College, London
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The primary aim of this study is to examine if long-term patterns of alcohol consumption are associated with time-to-onset for incident coronary heart disease (fatal and non-fatal), using data from multiple cohorts.

Description:

The relationship between alcohol consumption and coronary heart disease (CHD) remains an issue of debate. By capturing drinking trajectories over time, we may be equipped to obtain new insights into this relationship. Studies have shown that such trajectories have differential associations for intermediate traits (carotid intima-media thickness, pulse wave velocity and inflammatory markers), but no studies exist that link stability of drinking to actual CHD. The current study will employ a longitudinal cohort design to evaluate the association between long-term alcohol consumption trajectories and time-to-event for CHD. Data will be drawn from six cohorts (five British, one French). The combined participant pool comprises 64,926 individuals (58% male, individual cohort sizes ranging from 1,444 to 25,636 participants); those with a baseline history of CHD will be excluded. Repeat alcohol intake measurements across a 10-year interval will be the exposure, with participants' intake trajectory defined according to their alcohol consumption volume and its consistency over time. To account for heterogeneity across cohorts, individual participant data meta-analysis methods will be employed in determining CHD diagnosis rates and hazard ratios for the different intake trajectories, with adjustment for relevant demographic and clinical characteristics. Results from the modelling work illustrating the form and magnitude of the association between the alcohol intake categories and CHD will be presented.

This work will help further understanding of the role that alcohol intake and its stability over time play in subsequent CHD risk, and will have implications for our understanding of alcohol's relationship to cardiovascular health in the general population.

Recruitment information / eligibility
Status Completed
Enrollment 35132
Est. completion date December 12, 2017
Est. primary completion date December 12, 2017
Accepts healthy volunteers No
Gender All
Age group 32 Years and older
Eligibility Inclusion Criteria:

- Participated in cohort studies being investigated

- Provided alcohol intake data at least one time point

- Was included in coronary heart disease onset tracking

Exclusion Criteria:

- Left cohort study prior to completion of 10 year exposure window

- Had history of coronary heart disease before end of 10 year exposure window

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
United Kingdom University College London London

Sponsors (3)
Lead Sponsor Collaborator
University College, London Alcohol Research UK, Medical Research Council

Country where clinical trial is conducted

United Kingdom, 

References & Publications (7)

Benzeval M, Der G, Ellaway A, Hunt K, Sweeting H, West P, Macintyre S. Cohort profile: west of Scotland twenty-07 study: health in the community. Int J Epidemiol. 2009 Oct;38(5):1215-23. doi: 10.1093/ije/dyn213. Epub 2008 Oct 17. Erratum in: Int J Epidemiol. 2009 Dec;38(6):1752. — View Citation

Britton A, Marmot MG, Shipley MJ. How does variability in alcohol consumption over time affect the relationship with mortality and coronary heart disease? Addiction. 2010 Apr;105(4):639-45. doi: 10.1111/j.1360-0443.2009.02832.x. Epub 2010 Feb 9. — View Citation

Day N, Oakes S, Luben R, Khaw KT, Bingham S, Welch A, Wareham N. EPIC-Norfolk: study design and characteristics of the cohort. European Prospective Investigation of Cancer. Br J Cancer. 1999 Jul;80 Suppl 1:95-103. — View Citation

Goldberg M, Leclerc A, Zins M. Cohort Profile Update: The GAZEL Cohort Study. Int J Epidemiol. 2015 Feb;44(1):77-77g. doi: 10.1093/ije/dyu224. Epub 2014 Nov 23. — View Citation

Marmot M, Brunner E. Cohort Profile: the Whitehall II study. Int J Epidemiol. 2005 Apr;34(2):251-6. Epub 2004 Dec 2. — View Citation

Roerecke M, Rehm J. The cardioprotective association of average alcohol consumption and ischaemic heart disease: a systematic review and meta-analysis. Addiction. 2012 Jul;107(7):1246-60. doi: 10.1111/j.1360-0443.2012.03780.x. Epub 2012 Mar 21. Review. — View Citation

Wadsworth M, Kuh D, Richards M, Hardy R. Cohort Profile: The 1946 National Birth Cohort (MRC National Survey of Health and Development). Int J Epidemiol. 2006 Feb;35(1):49-54. Epub 2005 Oct 4. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Coronary Heart Disease Time-to-onset for coronary heart disease (fatal or non-fatal), as ascertained from linked health record data From last date of alcohol assessment until the date of hospitalisation or death due to coronary heart disease, up to 22 years depending on cohort
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