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Body Mass Index and Initial Presentations of Cardiovascular Diseases

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Disease Information

Descriptive Information
Brief Title † Body Mass Index and Initial Presentations of Cardiovascular Diseases
Official Title † Body Mass Index and Initial Presentations of Cardiovascular Diseases
Brief Summary The association between obesity and cardiovascular disease (CVD) has mostly been studied using broad endpoints or have focused on cause-specific mortality. The investigators aim to compare the effect of body mass index (BMI) on different types of initial presentation of CVD.
Detailed Description Obesity has many detrimental effects on the cardiovascular system that can manifest in a range of clinical presentations. Many of these are mediated by frequently coexisting conditions such as diabetes, hypertension and dyslipidemia but there are also direct, progressive effects on the arteries and the heart muscle. As evident from autopsies, even from early adulthood the degree of coronary artery disease (CAD) correlates with the BMI and particularly the amount of abdominal fat. The multiple mechanisms by which obesity exerts its effects are still being elucidated. Previous studies have assessed the effect of obesity on cause-specific mortality. Here the investigators analyze association of BMI with the first symptomatic presentation of cardiovascular disease across any phenotypes, to which the investigators refer to as "initial presentation" to distinguish from first presentation within a specific phenotype. For example, an initial presentation with myocardial infarction is an MI which is not preceded by stable angina, ischemic stroke or any other phenotype, rather than the first MI in a possible series of MIs, as is commonly used in other studies. Adjustments The key risk factor of interest is baseline BMI, which the investigators define as the most recent measurement of BMI recorded up to 2 years prior to cohort entry date. BMI will be analyzed based on the following categories: underweight (35 kg/m2). The healthy BMI category will be used as the reference in regression models. Associations with BMI will be adjusted for age, sex, ethnicity, social deprivation, smoking, diabetes, and systolic blood pressure, total cholesterol (TCHOL) and high-density lipoprotein cholesterol (HDL). All baseline covariates will be obtained from within a 2 year window prior to study entry. Statistical analyses Cause-specific Cox models will be used to measure the association between BMI categories and endpoints of interest. Multiple imputation will be used to replace missing values in prognostic factors. The investigators will estimate lifetime risk for each endpoint over time adjusting for competing risks.
Study Phase N/A
Study Type † Observational
Study Design † Observational Model: Cohort, Time Perspective: Retrospective
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Abdominal Aortic Aneurysm Acute Myocardial Infarction Stroke Heart Failure Peripheral Arterial Disease Angina
Intervention †
Study Arms / Comparison Groups CALIBER Healthy Cohort We will report findings from the CALIBER (CArdiovascular disease research using Linked BEspoke studies and Electronic Records) collaboration where we linked primary care data (from the General Practice Research Database [GPRD]) to three further sources of electronic health records: the Myocardial Ischemia National Audit Project registry (MINAP),cause specific discharge data from Hospital Episodes Statistics (HES) and cause specific mortality from the Office for National Statistics (ONS).
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status †
Estimated Enrollment † 2240000
Start Date † January 2001
Completion Date March 2010
Primary Completion Date March 2010
Eligibility Criteria † Inclusion Criteria: - Baseline age ≥30 years Exclusion Criteria: - prior atherosclerotic disease or stroke
Gender Both
Ages 30 Years - N/A
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts ††
Location Countries † United Kingdom
Administrative Information
NCT ID † NCT01704300
Organization ID CALIBER 10_14
Secondary IDs ††
Responsible Party Principal Investigator
Study Sponsor † University College, London
Collaborators ††
Investigators † : ,
Information Provided By
Verification Date October 2012
First Received Date † October 8, 2012
Last Updated Date October 10, 2012
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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