<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01687686</url>
  </required_header>
  <id_info>
    <org_study_id>CALIBER-12-01</org_study_id>
    <nct_id>NCT01687686</nct_id>
  </id_info>
  <brief_title>Differential Effects of Lipids on Cardiovascular Diseases: A CALIBER Study</brief_title>
  <official_title>Differential Effects of Total Cholesterol, Non-HDL Cholesterol and Triglycerides on Initial Presentation of Specific Cardiovascular Diseases (a CALIBER Study)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Wellcome Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The role of lipids as risk factors for cardiovascular events is well-documented, although&#xD;
      events studied have largely been broad classes without specific detail. This study will&#xD;
      examine a more refined set of endpoints.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The role of lipids (cholesterol and triglycerides) as risk factors for cardiovascular events&#xD;
      is well-documented. The Emerging Risk Factors Collaboration found approximately log-linear&#xD;
      adjusted associations of cholesterol concentrations with risks of first-time non-fatal&#xD;
      myocardial infarction; coronary heart disease (CHD) death; ischaemic, haemorrhagic and&#xD;
      unclassified stroke. They also found that triglycerides concentration was not independently&#xD;
      related with CHD risk after controlling for HDL cholesterol (HDL-C), non-HDL-C, and other&#xD;
      standard risk factors. The Prospective Studies Collaboration found that Higher HDL-C and&#xD;
      lower non-HDL-C levels were approximately independently associated with lower ischaemic heart&#xD;
      disease mortality. By focusing on broad outcomes these large meta-analyses conflate the&#xD;
      association between development of the different cardiovascular disease (CVD) phenotypes,&#xD;
      disease progression and mortality from cardiovascular causes.&#xD;
&#xD;
      With linked electronic health records, we have the potential for a cohort with sufficient&#xD;
      size and clinical detail to investigate the association between lipid concentrations and&#xD;
      initial presentation of a range of CVD phenotypes across cerebral, coronary, abdominal and&#xD;
      peripheral arterial circulations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2001</start_date>
  <completion_date type="Anticipated">December 2012</completion_date>
  <primary_completion_date type="Actual">March 2010</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of stable angina</measure>
    <time_frame>Cohort followed up for average of 7 years</time_frame>
    <description>Incidence of stable angina in study population</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Rate of unstable angina</measure>
    <time_frame>Cohort followed up for average of 7 years</time_frame>
    <description>Incidence of unstable angina in study population</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Rate of non ST elevation myocardial infarction</measure>
    <time_frame>Cohort followed up for average of 7 years</time_frame>
    <description>Incidence of non ST elevation myocardial infarction</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">175872</enrollment>
  <condition>Stable Angina</condition>
  <condition>Unstable Angina</condition>
  <condition>Non ST Elevation Myocardial Infarction</condition>
  <condition>ST Elevation Myocardial Infarction</condition>
  <condition>Myocardial Infarction Not Otherwise Specified</condition>
  <arm_group>
    <arm_group_label>All cohort</arm_group_label>
    <description>Initially healthy patients in General Practise Research Database (GPRD) meeting the inclusion criteria at any point between 1st January 2001 and 25th March 2010</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The cohort used in the present analysis was drawn from patients registered with 225 GPRD&#xD;
        general practices in England which consented to data linkage, covering approximately 5% of&#xD;
        the UK population. We used an open cohort design, where participants joined the cohort when&#xD;
        they met the inclusion criteria at any point between 1st January 2001 and 25th March 2010,&#xD;
        the date of the last GPRD data submission. Patients were included in cohort if, prior to&#xD;
        study entry, they were aged 30 to 100, had at least one year of electronic health record&#xD;
        data which meet General Practice Research Database data quality standards, and had no&#xD;
        record indicating any cardiovascular disease phenotypes. Patients were followed up until&#xD;
        the date of an initial presentation of one of our cardiovascular endpoints or were censored&#xD;
        on the date of leaving the practice or the date of last data submission from their&#xD;
        practice.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 30 to 100, had at least one year of electronic health record data which meet&#xD;
             General Practice Research Database data quality standards&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  No record indicating any cardiovascular disease phenotypes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University College London</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>WC1E 6BT</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <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. doi: 10.1016/S0140-6736(07)61778-4. Erratum In: Lancet. 2008 Jul 26;372(9635):292.</citation>
    <PMID>18061058</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>19903920</PMID>
  </reference>
  <reference>
    <citation>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.</citation>
    <PMID>16757495</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 19, 2012</study_first_posted>
  <last_update_submitted>September 18, 2012</last_update_submitted>
  <last_update_submitted_qc>September 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University College, London</investigator_affiliation>
    <investigator_full_name>Owen Nicholas</investigator_full_name>
    <investigator_title>Senior Medical Statistician</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Myocardial Infarction</mesh_term>
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>ST Elevation Myocardial Infarction</mesh_term>
    <mesh_term>Angina, Stable</mesh_term>
    <mesh_term>Angina, Unstable</mesh_term>
    <mesh_term>Non-ST Elevated Myocardial Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01687686
org study id: CALIBER-12-01
nct id: NCT01687686
lead sponsor: 
collaborator: 
has dmc: Yes
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.
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.
observational model: Cohort
time perspective: Retrospective
measure: Rate of stable angina
time frame: Cohort followed up for average of 7 years
description: Incidence of stable angina in study population
measure: Rate of unstable angina
time frame: Cohort followed up for average of 7 years
description: Incidence of unstable angina in study population
measure: Rate of non ST elevation myocardial infarction
time frame: Cohort followed up for average of 7 years
description: Incidence of non ST elevation myocardial infarction
arm group label: All cohort
description: Initially healthy patients in General Practise Research Database (GPRD) meeting the inclusion criteria at any point between 1st January 2001 and 25th March 2010
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United Kingdom
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. doi: 10.1016/S0140-6736(07)61778-4. Erratum In: Lancet. 2008 Jul 26;372(9635):292.
PMID: 18061058
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.
PMID: 19903920
citation: 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.
PMID: 16757495
responsible party type: Principal Investigator
investigator affiliation: University College, London
investigator full name: Owen Nicholas
investigator title: Senior Medical Statistician
mesh term: Cardiovascular Diseases
mesh term: Myocardial Infarction
mesh term: Angina Pectoris
mesh term: ST Elevation Myocardial Infarction
mesh term: Angina, Stable
mesh term: Angina, Unstable
mesh term: Non-ST Elevated Myocardial Infarction
mesh term: Infarction