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Alcohol Consumption and Coronary Heart Disease Onset

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ClinicalTrials.gov Identifier: NCT03133689
Recruitment Status : Completed
First Posted : April 28, 2017
Last Update Posted : December 22, 2017
Sponsor:
Collaborators:
Medical Research Council
Alcohol Research UK
Information provided by (Responsible Party):
University College, London

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.

Condition or disease
Coronary Heart Disease

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
Actual Enrollment : 35132 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Alcohol Consumption and Time-to-onset for Coronary Heart Disease: An Individual Participant Data Meta-analysis
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : December 12, 2017
Actual Study Completion Date : December 12, 2017

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   32 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03133689


Locations
United Kingdom
University College London
London, United Kingdom, WC1E 6BT
Sponsors and Collaborators
University College, London
Medical Research Council
Alcohol Research UK
Investigators
Principal Investigator: D O'Neill, PhD University College, London

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT03133689     History of Changes
Other Study ID Numbers: UCLAlcoholLifecourse_CHDStudy
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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).

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University College, London:
Alcohol
Coronary heart disease
Ischemic heart disease
Cardiovascular health
Individual participant data meta-analysis
Longitudinal

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Alcohol Drinking
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Drinking Behavior
Ethanol
Anti-Infective Agents, Local
Anti-Infective Agents
Central Nervous System Depressants
Physiological Effects of Drugs