- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01687686
Differential Effects of Lipids on Cardiovascular Diseases: A CALIBER Study
Differential Effects of Total Cholesterol, Non-HDL Cholesterol and Triglycerides on Initial Presentation of Specific Cardiovascular Diseases (a CALIBER Study)
Study Overview
Status
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Greater London
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London, Greater London, United Kingdom, WC1E 6BT
- University College London
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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
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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
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Incidence of stable angina in study population
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Cohort followed up for average of 7 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Rate of unstable angina
Time Frame: Cohort followed up for average of 7 years
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Incidence of unstable angina in study population
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Cohort followed up for average of 7 years
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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
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Incidence of non ST elevation myocardial infarction
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Cohort followed up for average of 7 years
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
General Publications
- 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. doi: 10.1016/S0140-6736(07)61778-4. Erratum In: Lancet. 2008 Jul 26;372(9635):292.
- 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.
- 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. doi: 10.1136/bmj.38855.610324.80. Epub 2006 Jun 6. Erratum In: BMJ. 2006 Sep 2;333(7566):468.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Ischemia
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Vascular Diseases
- Pain
- Neurologic Manifestations
- Chest Pain
- Myocardial Infarction
- Infarction
- Cardiovascular Diseases
- ST Elevation Myocardial Infarction
- Angina Pectoris
- Angina, Stable
- Angina, Unstable
- Non-ST Elevated Myocardial Infarction
Other Study ID Numbers
- CALIBER-12-01
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.
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