Differential Effects of Lipids on Cardiovascular Diseases: A CALIBER Study

September 18, 2012 updated by: Owen Nicholas, University College, London

Differential Effects of Total Cholesterol, Non-HDL Cholesterol and Triglycerides on Initial Presentation of Specific Cardiovascular Diseases (a CALIBER Study)

The role of lipids as risk factors for cardiovascular events is well-documented, although events studied have largely been broad classes without specific detail. This study will examine a more refined set of endpoints.

Study Overview

Detailed Description

The role of lipids (cholesterol and triglycerides) as risk factors for cardiovascular events is well-documented. The Emerging Risk Factors Collaboration found approximately log-linear adjusted associations of cholesterol concentrations with risks of first-time non-fatal myocardial infarction; coronary heart disease (CHD) death; ischaemic, haemorrhagic and unclassified stroke. They also found that triglycerides concentration was not independently related with CHD risk after controlling for HDL cholesterol (HDL-C), non-HDL-C, and other standard risk factors. The Prospective Studies Collaboration found that Higher HDL-C and lower non-HDL-C levels were approximately independently associated with lower ischaemic heart disease mortality. By focusing on broad outcomes these large meta-analyses conflate the association between development of the different cardiovascular disease (CVD) phenotypes, disease progression and mortality from cardiovascular causes.

With linked electronic health records, we have the potential for a cohort with sufficient size and clinical detail to investigate the association between lipid concentrations and initial presentation of a range of CVD phenotypes across cerebral, coronary, abdominal and peripheral arterial circulations.

Study Type

Observational

Enrollment (Actual)

175872

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Greater London
      • London, Greater London, United Kingdom, WC1E 6BT
        • University College London

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The cohort used in the present analysis was drawn from patients registered with 225 GPRD general practices in England which consented to data linkage, covering approximately 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 2001 and 25th March 2010, the date of the last GPRD data submission. Patients were included in cohort if, prior to study entry, they were aged 30 to 100, had at least one year of electronic health record data which meet General Practice Research Database data quality standards, and had no record indicating any cardiovascular disease phenotypes. 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 or the date of last data submission from their practice.

Description

Inclusion Criteria:

  • Aged 30 to 100, had at least one year of electronic health record data which meet General Practice Research Database data quality standards

Exclusion Criteria:

  • No record indicating any cardiovascular disease phenotypes

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
All cohort
Initially healthy patients in General Practise Research Database (GPRD) meeting the inclusion criteria at any point between 1st January 2001 and 25th March 2010

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of stable angina
Time Frame: Cohort followed up for average of 7 years
Incidence of stable angina in study population
Cohort followed up for average of 7 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of unstable angina
Time Frame: Cohort followed up for average of 7 years
Incidence of unstable angina in study population
Cohort followed up for average of 7 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of non ST elevation myocardial infarction
Time Frame: Cohort followed up for average of 7 years
Incidence of non ST elevation myocardial infarction
Cohort followed up for average of 7 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2001

Primary Completion (Actual)

March 1, 2010

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

September 13, 2012

First Submitted That Met QC Criteria

September 18, 2012

First Posted (Estimate)

September 19, 2012

Study Record Updates

Last Update Posted (Estimate)

September 19, 2012

Last Update Submitted That Met QC Criteria

September 18, 2012

Last Verified

September 1, 2012

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on ST Elevation Myocardial Infarction

3
Subscribe