Differential Effects of Lipids on Cardiovascular Diseases: A CALIBER Study

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Wellcome Trust
Information provided by (Responsible Party):
Owen Nicholas, University College, London
ClinicalTrials.gov Identifier:
NCT01687686
First received: September 13, 2012
Last updated: September 18, 2012
Last verified: September 2012
  Purpose

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.


Condition
Stable Angina
Unstable Angina
Non ST Elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Myocardial Infarction Not Otherwise Specified

Study Type: Observational
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • Rate of stable angina [ Time Frame: Cohort followed up for average of 7 years ] [ Designated as safety issue: No ]
    Incidence of stable angina in study population


Secondary Outcome Measures:
  • Rate of unstable angina [ Time Frame: Cohort followed up for average of 7 years ] [ Designated as safety issue: No ]
    Incidence of unstable angina in study population


Other Outcome Measures:
  • Rate of non ST elevation myocardial infarction [ Time Frame: Cohort followed up for average of 7 years ] [ Designated as safety issue: No ]
    Incidence of non ST elevation myocardial infarction


Enrollment: 175872
Study Start Date: January 2001
Estimated Study Completion Date: December 2012
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/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

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.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687686

Locations
United Kingdom
University College London
London, Greater London, United Kingdom, WC1E 6BT
Sponsors and Collaborators
University College, London
Wellcome Trust
  More Information

Additional Information:
Publications:
Responsible Party: Owen Nicholas, Senior Medical Statistician, University College, London
ClinicalTrials.gov Identifier: NCT01687686     History of Changes
Other Study ID Numbers: CALIBER-12-01
Study First Received: September 13, 2012
Last Updated: September 18, 2012
Health Authority: United Kingdom: CALIBER oversight committee

Additional relevant MeSH terms:
Angina Pectoris
Angina, Unstable
Cardiovascular Diseases
Infarction
Myocardial Infarction
Myocardial Ischemia
Heart Diseases
Vascular Diseases
Chest Pain
Pain
Signs and Symptoms
Ischemia
Pathologic Processes
Necrosis

ClinicalTrials.gov processed this record on April 23, 2014