Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Alcohol Consumption and Coronary Heart Disease Onset

21. december 2017 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

35132

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

32 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Coronary Heart Disease
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University College, London

Samarbejdspartnere

Medical Research Council
Alcohol Research UK

Efterforskere

  • Ledende efterforsker: D O'Neill, PhD, University College, London

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2017

Primær færdiggørelse (Faktiske)

12. december 2017

Studieafslutning (Faktiske)

12. december 2017

Datoer for studieregistrering

Først indsendt

26. april 2017

Først indsendt, der opfyldte QC-kriterier

27. april 2017

Først opslået (Faktiske)

28. april 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. december 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. december 2017

Sidst verificeret

1. april 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • UCLAlcoholLifecourse_CHDStudy

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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).

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Koronar hjertesygdom

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Serbia

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner