Differential Effects of Lipids on Cardiovascular Diseases: A CALIBER Study

Stable Angina Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01687686
• Other study ID #: CALIBER-12-01
• Status: Active, not recruiting
• Phase: N/A
• First received: September 13, 2012
• Last updated: September 18, 2012
• Start date: January 2001
• Est. completion date: December 2012

Study information

• Verified date: September 2012
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: CALIBER oversight committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 175872
• Est. completion date: December 2012
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Angina, Stable
• Angina, Unstable
• Cardiovascular Diseases
• Infarction
• Myocardial Infarction
• Myocardial Infarction Not Otherwise Specified
• Non ST Elevation Myocardial Infarction
• ST Elevation Myocardial Infarction
• Stable Angina
• Unstable Angina

Locations

Country	Name	City	State
United Kingdom	University College London	London	Greater London

Sponsors (2)

Lead Sponsor	Collaborator
University College, London	Wellcome Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (3)

Ebrahim S, Sung J, Song YM, Ferrer RL, Lawlor DA, Davey Smith G. Serum cholesterol, haemorrhagic stroke, ischaemic stroke, and myocardial infarction: Korean national health system prospective cohort study. BMJ. 2006 Jul 1;333(7557):22. Epub 2006 Jun 6. Erratum in: BMJ. 2006 Sep 2;333(7566):468. — View Citation

Emerging Risk Factors Collaboration, Di Angelantonio E, Sarwar N, Perry P, Kaptoge S, Ray KK, Thompson A, Wood AM, Lewington S, Sattar N, Packard CJ, Collins R, Thompson SG, Danesh J. Major lipids, apolipoproteins, and risk of vascular disease. JAMA. 2009 Nov 11;302(18):1993-2000. doi: 10.1001/jama.2009.1619. — View Citation

Prospective Studies Collaboration, Lewington S, Whitlock G, Clarke R, Sherliker P, Emberson J, Halsey J, Qizilbash N, Peto R, Collins R. Blood cholesterol and vascular mortality by age, sex, and blood pressure: a meta-analysis of individual data from 61 prospective studies with 55,000 vascular deaths. Lancet. 2007 Dec 1;370(9602):1829-39. Review. Erratum in: Lancet. 2008 Jul 26;372(9635):292. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of non ST elevation myocardial infarction	Incidence of non ST elevation myocardial infarction	Cohort followed up for average of 7 years	No
Primary	Rate of stable angina	Incidence of stable angina in study population	Cohort followed up for average of 7 years	No
Secondary	Rate of unstable angina	Incidence of unstable angina in study population	Cohort followed up for average of 7 years	No