This trial is active, not recruiting.

Conditions stable angina, unstable angina, non st elevation myocardial infarction, st elevation myocardial infarction, myocardial infarction not otherwise specified
Sponsor University College, London
Collaborator Wellcome Trust
Start date January 2001
End date March 2010
Trial size 175872 participants
Trial identifier NCT01687686, CALIBER-12-01


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Initially healthy patients in General Practise Research Database (GPRD) meeting the inclusion criteria at any point between 1st January 2001 and 25th March 2010

Primary Outcomes

Rate of stable angina
time frame: Cohort followed up for average of 7 years

Secondary Outcomes

Rate of unstable angina
time frame: Cohort followed up for average of 7 years

Eligibility Criteria

Male or female participants at least 30 years old.

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

Additional Information

Official title Differential Effects of Total Cholesterol, Non-HDL Cholesterol and Triglycerides on Initial Presentation of Specific Cardiovascular Diseases (a CALIBER Study)
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2012.
Information provided to ClinicalTrials.gov by University College, London.