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The Role of Alcohol Consumption in the Aetiology of Different Cardiovascular Disease Phenotypes: a CALIBER Study

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ClinicalTrials.gov Identifier: NCT01864031
Recruitment Status : Unknown
Verified May 2013 by Harry Hemingway, University College, London.
Recruitment status was:  Active, not recruiting
First Posted : May 29, 2013
Last Update Posted : May 29, 2013
Sponsor:
Information provided by (Responsible Party):
Harry Hemingway, University College, London

Brief Summary:
The association between alcohol consumption and cardiovascular disease (CVD) has mostly been examined using broad endpoints or cause-specific mortality. The purpose of our study is to compare the effect of alcohol consumption in the aetiology of a range of cardiovascular disease phenotypes.

Condition or disease
Chronic Stable Angina Unstable Angina Coronary Heart Disease Not Otherwise Specified Acute Myocardial Infarction Heart Failure Ventricular Arrhythmias Cardiac Arrest Abdominal Aortic Aneurysm Peripheral Arterial Disease Ischaemic Stroke Subarachnoid Haemorrhagic Stroke Intracerebral Haemorrhagic Stroke Stroke Not Otherwise Specified Sudden Cardiac Death Unheralded Coronary Death Mortality Coronary Heart Disease (CHD) Cardiovascular Disease (CVD) Fatal Cardiovascular Disease (Fatal CVD) ST Elevation Myocardial Infarction (STEMI) Non-ST Elevation Myocardial Infarction (nSTEMI) Myocardial Infarction Not Otherwise Specified (MI NOS)

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 2240000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Role of Alcohol Consumption in the Aetiology of Different Cardiovascular Disease Phenotypes: a CALIBER Study Using Linked Electronic Health Records
Study Start Date : January 1997
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Alcohol




Primary Outcome Measures :
  1. Initial presentation of cardiovascular disease [ Time Frame: Study follow-up will commence on the earliest date that a patient fulfils the study inclusion criteria during the period between 1st January 1997 and 25th March 2010 (maximum of 13 years follow-up) ]
    See "Conditions" and "Detailed Description" sections for further description of the endpoints used.


Secondary Outcome Measures :
  1. Non-CVD mortality [ Time Frame: Same as for primary outcomes (maximum of 13 years follow-up) ]
    Death from non-CVD causes.



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Ages Eligible for Study:   30 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The cohort used in the present study was drawn from patients registered with GPRD general practices in England that consented to data linkage (approx. 5% of the UK population). We used an open cohort design, where participants joined the cohort when they met the inclusion criteria at any point between 1st January 1997 and 25th March 2010 (the last GPRD data submission). Patients were included in cohort if they were aged ≥ 30 years, had at least one year of electronic health record data which met GPRD data quality standards, and had no record indicating any cardiovascular disease prior to study entry. Patients were followed up until the date of an initial presentation of one of our cardiovascular endpoints or were censored on the date of leaving the practice/last data submission from their practice. Patients who died before 1st January 2001 were excluded as cause-specific mortality data was not available for them (this approach is adopted in the Prospective Studies Collaboration).
Criteria

Inclusion Criteria:

  • Aged ≥ 30 years.
  • Patient in a GPRD registered practice that has consented to the linkage process (who also met data quality standards).

Exclusion Criteria:

  • A recorded history of any cardiovascular disease phenotype prior to entering the study.
  • Cause of death unknown.

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): NCT01864031


Locations
United Kingdom
University College London
London, United Kingdom
Sponsors and Collaborators
University College, London
Investigators
Principal Investigator: Steven Bell, PhD University College, London
Study Director: Harry Hemingway, FRCP University College, London

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Harry Hemingway, Professor of Clinical Epidemiology, University College, London
ClinicalTrials.gov Identifier: NCT01864031     History of Changes
Other Study ID Numbers: CALIBER 12-02
086091/Z/08/Z ( Other Grant/Funding Number: Wellcome Trust )
RP-PG-0407-10314 ( Other Grant/Funding Number: National Institute for Health Research (NIHR) )
First Posted: May 29, 2013    Key Record Dates
Last Update Posted: May 29, 2013
Last Verified: May 2013

Keywords provided by Harry Hemingway, University College, London:
Alcohol
Drinking
Abstainers
Former drinkers
Ex-drinkers
Aetiology
Initial presentation
Chronic Stable Angina
Unstable Angina
Coronary Heart Disease Not Otherwise Specified
Acute Myocardial Infarction
Heart Failure
ST elevation Myocardial Infarction (STEMI)
non-ST elevation Myocardial Infarction (nSTEMI)
Myocardial Infarction Not Otherwise Specified (MI NOS)
Ventricular Arrhythmias
Cardiac Arrest
Abdominal Aortic Aneurysm
Peripheral Arterial Disease
Ischaemic Stroke
Subarachnoid Haemorrhagic Stroke
Intracerebral haemorrhagic Stroke
Stroke Not Otherwise Specified
Sudden Cardiac Death
Unheralded Coronary Death
Mortality
Coronary Heart Disease (CHD)
Cardiovascular Disease (CVD)
Fatal Cardiovascular Disease (fatal CVD)

Additional relevant MeSH terms:
Stroke
Heart Failure
Infarction
Cardiovascular Diseases
Heart Diseases
Myocardial Infarction
Aneurysm
Death
Angina Pectoris
Heart Arrest
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Aortic Aneurysm
Peripheral Arterial Disease
Peripheral Vascular Diseases
Aortic Aneurysm, Abdominal
ST Elevation Myocardial Infarction
Angina, Stable
Death, Sudden, Cardiac
Angina, Unstable
Alcohol Drinking
Non-ST Elevated Myocardial Infarction
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Ischemia