Alcohol Consumption and Coronary Heart Disease Onset

December 21, 2017 updated by: University College, London

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

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

35132

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • London, United Kingdom, WC1E 6BT
        • University College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

32 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participants will be drawn from birth, regional and occupational cohort studies in England, Wales, Scotland and France.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
EPIC-Norfolk
This cohort comprises 25,636 residents of a predefined English healthcare region (11,606 men and 14,030 women). Participants in this cohort study were originally recruited from 35 general practices in Norfolk, England as part of an investigation into diet and cancer, but the study's scope was subsequently widened to include additional outcomes including cardiovascular diseases.
GAZEL
This cohort comprises 20,625 employees of French gas and electricity companies (15,011 men and 5,614 women). The cohort commenced data collection in 1989 and follow-up assessments were subsequently completed on an annual basis. The data have undergone linkage to national health administrative datasets.
NSHD
This dataset comes from the 1946 National Birth Cohort study, which comprises all persons born in England, Scotland and Wales in one week in March 1946. The cohort comprises 5,362 individuals (2,815 men and 2,547 women). Data have been collected from participants on a regular basis throughout their life, including information on lifestyle and, in combination with administrative datasets, on health outcomes.
Twenty-07-1930s
This cohort comprises 1,551 Scottish participants (702 men and 849 women) born around 1932 who were recruited in 1986 as part of a study of health inequalities. The repeated nature of the data collection will enable identification of longitudinal alcohol intake patterns, while linkage to Scottish health system records will enable identification of coronary heart disease onset.
Twenty-07-1950s
This cohort comprises 1,444 Scottish participants (656 men and 788 women) born around 1952 who were recruited in 1986, alongside the T-07-1930s' cohort, as part of a study of health inequalities. Participant health was tracked through linkage with national health records.
Whitehall II
This cohort comprises 10,308 British civil servants (6,895 men and 3,413 women). The cohort study commenced data collection in 1985 and participants have since undergone questionnaire and clinical assessments across regular intervals. Additional tracking of health outcomes has been performed through linkage with administrative databases. Demographic, behavioural and clinical data will be sourced from this cohort for the purposes of the current study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary Heart Disease
Time Frame: 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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

Medical Research Council
Alcohol Research UK

Investigators

  • Principal Investigator: D O'Neill, PhD, University College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2017

Primary Completion (Actual)

December 12, 2017

Study Completion (Actual)

December 12, 2017

Study Registration Dates

First Submitted

April 26, 2017

First Submitted That Met QC Criteria

April 27, 2017

First Posted (Actual)

April 28, 2017

Study Record Updates

Last Update Posted (Actual)

December 22, 2017

Last Update Submitted That Met QC Criteria

December 21, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UCLAlcoholLifecourse_CHDStudy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Researchers can request access to anonymised data. The data are already available to bona fide researchers via application: European Prospective Investigation of Cancer-Norfolk (EPIC-Norfolk; http://www.srl.cam.ac.uk/epic/contact/), Gaz et Electricité (GAZEL; http://www.gazel.inserm.fr/en/projects/submitting-a-project.html), Medical Research Council National Survey of Health and Development 1946 (NSHD; http://www.nshd.mrc.ac.uk/data/), West of Scotland Twenty-07 Study (T-07-1930s and T-07-1950s; http://2007study.sphsu.mrc.ac.uk/Information-on-data-sharing.html), and Whitehall II (WII; http://www.ucl.ac.uk/whitehallII/data-sharing).

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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