Differential Effects of Lipids on Cardiovascular Diseases: A CALIBER Study

Sponsor
University College, London (Other)
Overall Status
Unknown status
CT.gov ID
NCT01687686
Collaborator
Wellcome Trust (Other)
175,872
1
143
1230

Study Details

Study Description

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 Design

Study Type:
Observational
Actual Enrollment :
175872 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Differential Effects of Total Cholesterol, Non-HDL Cholesterol and Triglycerides on Initial Presentation of Specific Cardiovascular Diseases (a CALIBER Study)
Study Start Date :
Jan 1, 2001
Actual Primary Completion Date :
Mar 1, 2010
Anticipated Study Completion Date :
Dec 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

  1. Rate of stable angina [Cohort followed up for average of 7 years]

    Incidence of stable angina in study population

Secondary Outcome Measures

  1. Rate of unstable angina [Cohort followed up for average of 7 years]

    Incidence of unstable angina in study population

Other Outcome Measures

  1. Rate of non ST elevation myocardial infarction [Cohort followed up for average of 7 years]

    Incidence of non ST elevation myocardial infarction

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University College London London Greater London United Kingdom WC1E 6BT

Sponsors and Collaborators

  • University College, London
  • Wellcome Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Owen Nicholas, Senior Medical Statistician, University College, London
ClinicalTrials.gov Identifier:
NCT01687686
Other Study ID Numbers:
  • CALIBER-12-01
First Posted:
Sep 19, 2012
Last Update Posted:
Sep 19, 2012
Last Verified:
Sep 1, 2012

Study Results

No Results Posted as of Sep 19, 2012