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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2013 by University College, London.
Recruitment status was:  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Harry Hemingway, University College, London
ClinicalTrials.gov Identifier:
NCT01864031
First received: May 23, 2013
Last updated: May 28, 2013
Last verified: May 2013
  Purpose
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
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)

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by University College, London:

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


Enrollment: 2240000
Study Start Date: January 1997
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   30 Years and older   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
Publications:
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) )
Study First Received: May 23, 2013
Last Updated: May 28, 2013

Keywords provided by 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
Angina Pectoris
Death
Heart Arrest
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Aortic Aneurysm
Peripheral Arterial Disease
Peripheral Vascular Diseases
Angina, Stable
Aortic Aneurysm, Abdominal
Death, Sudden, Cardiac
Angina, Unstable
Alcohol Drinking
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on April 26, 2017