CClinicalTrials.gg
Status unknownNCT01687686Updated Sep 19, 2012

Differential Effects of Lipids on Cardiovascular Diseases: A CALIBER Study

An observational study in Stable Angina, Unstable Angina and Non ST Elevation Myocardial Infarction, sponsored by University College, London. Status unknown at 1 site in United Kingdom. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2012-09-19.

Sponsored by University College, London · Observational

The sponsor has not verified this record recently (last verified Sep 2012), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
175,872
Ages
30 Years and older
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Stable Angina
  • Unstable Angina
  • Non ST Elevation Myocardial Infarction
  • ST Elevation Myocardial Infarction
  • Myocardial Infarction Not Otherwise Specified
03

In context

Cardiovascular Diseases

4,905 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's enrollment of 175,872 is above the median of 563 across 1,486 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University College, London is the lead sponsor of 632 studies on the registry; 145 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
30 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

The cohort used in the present analysis was drawn from patients registered with 225 GPRD general practices in England which consented to data linkage, covering approximately 5% of the UK population. We used an open cohort design, where participants joined the cohort when they met the inclusion criteria at any point between 1st January 2001 and 25th March 2010, the date of the last GPRD data submission. Patients were included in cohort if, prior to study entry, they were aged 30 to 100, had at least one year of electronic health record data which meet General Practice Research Database data quality standards, and had no record indicating any cardiovascular disease phenotypes. Patients were followed up until the date of an initial presentation of one of our cardiovascular endpoints or were censored on the date of leaving the practice or the date of last data submission from their practice.

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

Exclusion Criteria:

  • No record indicating any cardiovascular disease phenotypes
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
175,872 participants (actual)

Groups and cohorts

  • 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 researchers measure

Primary outcomes

  1. Rate of stable angina

    Incidence of stable angina in study population

    Time frame: Cohort followed up for average of 7 years

Secondary outcomes

  1. Rate of unstable angina

    Incidence of unstable angina in study population

    Time frame: Cohort followed up for average of 7 years

Other outcomes

  1. Rate of non ST elevation myocardial infarction

    Incidence of non ST elevation myocardial infarction

    Time frame: Cohort followed up for average of 7 years

07

Study locations

1 site
  • University College London
    London, Greater London WC1E 6BT, United Kingdom
08

References and documents

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. PubMed 18061058 ↗
  • 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. PubMed 19903920 ↗
  • 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. PubMed 16757495 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 19, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01687686
Lead sponsor
University College, London
Collaborators
Wellcome Trust
Responsible party
Owen Nicholas (Senior Medical Statistician, University College, London) — Principal investigator
First posted
Sep 19, 2012
Start date
Jan 2001
Primary completion
Mar 2010
Completion
Dec 2012 (estimated)
Last update
Sep 19, 2012

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.

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