Alcohol Consumption and Coronary Heart Disease Onset
21 décembre 2017 mis à jour par: 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.
Aperçu de l'étude
Statut
Complété
Les conditions
Description détaillée
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.
Type d'étude
Observationnel
Inscription (Réel)
35132
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
-
London, Royaume-Uni, WC1E 6BT
- University College London
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
32 ans et plus (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
Méthode d'échantillonnage
Échantillon non probabiliste
Population étudiée
The participants will be drawn from birth, regional and occupational cohort studies in England, Wales, Scotland and France.
La 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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
|---|
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Coronary Heart Disease
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: D O'Neill, PhD, University College, London
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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. Erratum In: Int J Epidemiol. 2009 Dec;38(6):1752.
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 mars 2017
Achèvement primaire (Réel)
12 décembre 2017
Achèvement de l'étude (Réel)
12 décembre 2017
Dates d'inscription aux études
Première soumission
26 avril 2017
Première soumission répondant aux critères de contrôle qualité
27 avril 2017
Première publication (Réel)
28 avril 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
22 décembre 2017
Dernière mise à jour soumise répondant aux critères de contrôle qualité
21 décembre 2017
Dernière vérification
1 avril 2017
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- UCLAlcoholLifecourse_CHDStudy
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
OUI
Description du régime IPD
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).
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
Essais cliniques sur Maladie coronarienne
-
Region SkaneInscription sur invitationInsuffisance cardiaque New York Heart Association (NYHA) Classe II | Insuffisance cardiaque Classe III de la New York Heart Association (NYHA)Suède
-
Medical University of BialystokMedical University of Lodz; Poznan University of Medical Sciences; Nicolaus... et autres collaborateursRésiliéInsuffisance cardiaque, systolique | Insuffisance cardiaque avec fraction d'éjection réduite | Insuffisance cardiaque New York Heart Association Classe IV | Insuffisance cardiaque Classe III de la New York Heart AssociationPologne
-
University of WashingtonAmerican Heart AssociationComplétéInsuffisance cardiaque, congestive | Altération mitochondriale | Insuffisance cardiaque New York Heart Association Classe IVÉtats-Unis
-
Portuguese Association of Interventional CardiologyMedtronicRecrutementSténose aortique symptomatique sévère (définie comme classe ≥ II de la New York Heart Association (NYHA))Le Portugal