Differential Effects of Lipids on Cardiovascular Diseases: A CALIBER Study

• Conditions: Stable Angina; Unstable Angina; Non ST Elevation Myocardial Infarction; ST Elevation Myocardial Infarction; Myocardial Infarction Not Otherwise Specified

• Registration Number: NCT01687686
• Lead Sponsor: University College, London

Brief Summary

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.

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 Timeline

• Study Start: 2001-01
• Primary Completion: 2010-03
• Status Verified: 2012-09
• Study First Submitted: 2012-09-13
• Study First Submitted QC: 2012-09-18
• Last Update Submitted: 2012-09-18
• Study First Posted: 2012-09-19
• Last Update Posted: 2012-09-19
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 175872

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Rate of stable angina	Cohort followed up for average of 7 years	Incidence of stable angina in study population

Secondary Outcome Measures

Name	Time	Method
Rate of unstable angina	Cohort followed up for average of 7 years	Incidence of unstable angina in study population

Trial Locations

Locations (1)

University College London; 🇬🇧 London, Greater London, United Kingdom