NCT03133689

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35,132

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

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

March 1, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 26, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 12, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2017

Completed
Last Updated

December 22, 2017

Status Verified

April 1, 2017

Enrollment Period

10 months

First QC Date

April 26, 2017

Last Update Submit

December 21, 2017

Conditions

Keywords

AlcoholCoronary heart diseaseIschemic heart diseaseCardiovascular healthIndividual participant data meta-analysisLongitudinal

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (6)

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.

Eligibility Criteria

Age32 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Participated in cohort studies being investigated
  • Provided alcohol intake data at least one time point
  • Was included in coronary heart disease onset tracking

You may not qualify if:

  • Left cohort study prior to completion of 10 year exposure window
  • Had history of coronary heart disease before end of 10 year exposure window

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, WC1E 6BT, United Kingdom

Location

Related Publications (8)

  • 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.

    PMID: 20148795BACKGROUND
  • 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.

    PMID: 22229788BACKGROUND
  • 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
  • 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. No abstract available.

    PMID: 10466767BACKGROUND
  • 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.

    PMID: 25422284BACKGROUND
  • 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. doi: 10.1093/ije/dyi201. Epub 2005 Oct 4. No abstract available.

    PMID: 16204333BACKGROUND
  • 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. No abstract available.

    PMID: 18930962BACKGROUND
  • O'Neill D, Britton A, Hannah MK, Goldberg M, Kuh D, Khaw KT, Bell S. Association of longitudinal alcohol consumption trajectories with coronary heart disease: a meta-analysis of six cohort studies using individual participant data. BMC Med. 2018 Aug 22;16(1):124. doi: 10.1186/s12916-018-1123-6.

Related Links

MeSH Terms

Conditions

Coronary DiseaseMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

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
SPONSOR

Study Record Dates

First Submitted

April 26, 2017

First Posted

April 28, 2017

Study Start

March 1, 2017

Primary Completion

December 12, 2017

Study Completion

December 12, 2017

Last Updated

December 22, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will share

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).

Locations