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Differential Effects of Lipids on Cardiovascular Diseases: A CALIBER Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2012 by Owen Nicholas, University College, London.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01687686
First Posted: September 19, 2012
Last Update Posted: September 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Wellcome Trust
Information provided by (Responsible Party):
Owen Nicholas, University College, London
  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)

Further study details as provided by Owen Nicholas, University College, London:

Primary Outcome Measures:
  • Rate of stable angina [ Time Frame: Cohort followed up for average of 7 years ]
    Incidence of stable angina in study population


Secondary Outcome Measures:
  • Rate of unstable angina [ Time Frame: Cohort followed up for average of 7 years ]
    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 ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687686


Locations
United Kingdom
University College London
London, Greater London, United Kingdom, WC1E 6BT
Sponsors and Collaborators
University College, London
Wellcome Trust
  More 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
First Submitted: September 13, 2012
First Posted: September 19, 2012
Last Update Posted: September 19, 2012
Last Verified: September 2012

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