<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/NCT03259100</url>
  </required_header>
  <id_info>
    <org_study_id>CDC and IPCC</org_study_id>
    <nct_id>NCT03259100</nct_id>
  </id_info>
  <brief_title>Temperature and Mortality</brief_title>
  <official_title>Impact of Increasing Temperature Over the Coming Century on Mortality From CVD and Stroke</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese Academy of Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese Academy of Sciences</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators evaluated the spatial association between, cardiovascular diseases (CVD)&#xD;
      and stroke mortality rate with average ambient temperature (Ta) , and then used this&#xD;
      relationship to model future temporal trends in mortality from CVD and stroke till the end of&#xD;
      century (2099) using different warming scenarios across the mainland USA.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      the investigators used data on mortality rate (per 100,000 individuals) for CVD and stroke&#xD;
      (between 2011 and 2013, age&gt;35years) from the publicly available Centers for disease&#xD;
      prevention and control (CDC) web site (www.cdc.gov). CVD mortality was defined as the number&#xD;
      of deaths per 100,000 personyears due to circulatory causes (International Statistical&#xD;
      Classification of Diseases, Tenth Revision, codes I00-I99).Oak Ridge National laboratory was&#xD;
      the source of the ambient temperature data (http://www.daac.ornl.gov: files B01, B02 and&#xD;
      C07).The investigators obtained data on prevalence of HTN (HTN was defined as systolic blood&#xD;
      pressure (BP) of at least 140 mm Hg, self-reported use of antihypertensive treatment, or&#xD;
      both) from county health rankings and roadmaps organisation (www.countyhealthrankings.org),&#xD;
      which were estimated based on National Health and Nutrition Examination Survey in five&#xD;
      two-year waves from 1999-2008 including 26,349 adults aged 30 years and older and from the&#xD;
      Behavioral Risk Factor Surveillance System (BRFSS) from 1997-2009 including 1,283,722 adults&#xD;
      aged 30 years and older.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2011</start_date>
  <completion_date type="Actual">February 1, 2013</completion_date>
  <primary_completion_date type="Actual">January 1, 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>spatial association between, cardiovascular diseases (CVD) and stroke mortality rate with average ambient temperature</measure>
    <time_frame>2011-2013</time_frame>
    <description>spatial association between, cardiovascular diseases (CVD) and stroke mortality rate with average ambient temperature</description>
  </primary_outcome>
  <enrollment type="Actual">17000000</enrollment>
  <condition>Cardiovascular Diseases</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>all the data collection have done by CDC.</intervention_name>
    <description>In this study there was no intervention, just simple data collection via CDC.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        We used data on mortality rate (per 100,000 individuals) for CVD and stroke (between 2011&#xD;
        and 2013, age&gt;35years) from the publicly available Centers for disease prevention and&#xD;
        control (CDC) web site (www.cdc.gov).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. age&gt;35 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <link>
    <url>http://www.cdc.gov</url>
    <description>CDC website</description>
  </link>
  <reference>
    <citation>Mazidi M, Speakman JR. Ambient particulate air pollution (PM2.5) is associated with the ratio of type 2 diabetes to obesity. Sci Rep. 2017 Aug 22;7(1):9144. doi: 10.1038/s41598-017-08287-1.</citation>
    <PMID>28831041</PMID>
  </reference>
  <results_reference>
    <citation>Mazidi M, Speakman JR. Higher densities of fast-food and full-service restaurants are not associated with obesity prevalence. Am J Clin Nutr. 2017 Aug;106(2):603-613. doi: 10.3945/ajcn.116.151407. Epub 2017 May 31.</citation>
    <PMID>28566310</PMID>
  </results_reference>
  <results_reference>
    <citation>Speakman JR, Heidari-Bakavoli S. Type 2 diabetes, but not obesity, prevalence is positively associated with ambient temperature. Sci Rep. 2016 Aug 1;6:30409. doi: 10.1038/srep30409.</citation>
    <PMID>27477955</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 19, 2017</study_first_submitted>
  <study_first_submitted_qc>August 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 22, 2017</last_update_submitted>
  <last_update_submitted_qc>August 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese Academy of Sciences</investigator_affiliation>
    <investigator_full_name>John Speakman</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all of our data are in public available, www.CDC.gov</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>2011-2013</ipd_time_frame>
    <ipd_access_criteria>there is nor criteria for the sharing these data, whole database is public access.</ipd_access_criteria>
    <ipd_url>http://www.CDC.gov</ipd_url>
  </patient_data>
  <!-- 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/NCT03259100
org study id: CDC and IPCC
nct id: NCT03259100
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The investigators evaluated the spatial association between, cardiovascular diseases (CVD)
      and stroke mortality rate with average ambient temperature (Ta) , and then used this
      relationship to model future temporal trends in mortality from CVD and stroke till the end of
      century (2099) using different warming scenarios across the mainland USA.
the investigators used data on mortality rate (per 100,000 individuals) for CVD and stroke
      (between 2011 and 2013, age>35years) from the publicly available Centers for disease
      prevention and control (CDC) web site (www.cdc.gov). CVD mortality was defined as the number
      of deaths per 100,000 personyears due to circulatory causes (International Statistical
      Classification of Diseases, Tenth Revision, codes I00-I99).Oak Ridge National laboratory was
      the source of the ambient temperature data (http://www.daac.ornl.gov: files B01, B02 and
      C07).The investigators obtained data on prevalence of HTN (HTN was defined as systolic blood
      pressure (BP) of at least 140 mm Hg, self-reported use of antihypertensive treatment, or
      both) from county health rankings and roadmaps organisation (www.countyhealthrankings.org),
      which were estimated based on National Health and Nutrition Examination Survey in five
      two-year waves from 1999-2008 including 26,349 adults aged 30 years and older and from the
      Behavioral Risk Factor Surveillance System (BRFSS) from 1997-2009 including 1,283,722 adults
      aged 30 years and older.
observational model: Ecologic or Community
time perspective: Retrospective
measure: spatial association between, cardiovascular diseases (CVD) and stroke mortality rate with average ambient temperature
time frame: 2011-2013
description: spatial association between, cardiovascular diseases (CVD) and stroke mortality rate with average ambient temperature
intervention type: Other
intervention name: all the data collection have done by CDC.
description: In this study there was no intervention, just simple data collection via CDC.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 35 Years
maximum age: N/A
healthy volunteers: No
url: http://www.cdc.gov
description: CDC website
citation: Mazidi M, Speakman JR. Ambient particulate air pollution (PM2.5) is associated with the ratio of type 2 diabetes to obesity. Sci Rep. 2017 Aug 22;7(1):9144. doi: 10.1038/s41598-017-08287-1.
PMID: 28831041
citation: Mazidi M, Speakman JR. Higher densities of fast-food and full-service restaurants are not associated with obesity prevalence. Am J Clin Nutr. 2017 Aug;106(2):603-613. doi: 10.3945/ajcn.116.151407. Epub 2017 May 31.
PMID: 28566310
citation: Speakman JR, Heidari-Bakavoli S. Type 2 diabetes, but not obesity, prevalence is positively associated with ambient temperature. Sci Rep. 2016 Aug 1;6:30409. doi: 10.1038/srep30409.
PMID: 27477955
responsible party type: Principal Investigator
investigator affiliation: Chinese Academy of Sciences
investigator full name: John Speakman
investigator title: Principal Investigator
mesh term: Cardiovascular Diseases
sharing ipd: Yes
ipd description: all of our data are in public available, www.CDC.gov
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd info type: Analytic Code
ipd time frame: 2011-2013
ipd access criteria: there is nor criteria for the sharing these data, whole database is public access.
ipd url: http://www.CDC.gov