<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/NCT03005834</url>
  </required_header>
  <id_info>
    <org_study_id>SHIP01</org_study_id>
    <nct_id>NCT03005834</nct_id>
  </id_info>
  <brief_title>The Sakakibara Health Integrative Profile Cohort Study</brief_title>
  <acronym>SHIP-CS</acronym>
  <official_title>Incidence of Cancers in Patients With Atherosclerotic Cardiovascular Diseases</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sakakibara Heart Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sakakibara Heart Institute</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Because of the genetic and traditional commonalities between the underlying causes of&#xD;
      atherosclerotic cardiovascular diseases (CVD) and cancers, we hypothesized that patients with&#xD;
      atherosclerotic CVD may have a high incidence of cancers when compared with those with&#xD;
      non-atherosclerotic CVD. To address this hypothesis, we investigated longitudinal clinical&#xD;
      outcomes in a total of 32,095 consecutive patients with CVD enrolled in the Sakakibara Health&#xD;
      Integrative Profile (SHIP) cohort study which was launched in 2006 for the purpose of&#xD;
      improving healthy life expectancy in patients with CVD in our institute.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The SHIP cohort study was launched in 2006 for the purpose of improving healthy life&#xD;
      expectancy in patients with any cardiovascular diseases (CVD) who were admitted to the&#xD;
      Sakakibara Heart Institute. The study used a continuous surveillance system to track all&#xD;
      subsequent incidents of CVD and/or non-CVD including cancers, via direct contact in the&#xD;
      outpatient department, hospital records, and a mailed questionnaire at least once a year.&#xD;
      Organ sites of cancers were also identified whenever possible. The study sorted any diagnoses&#xD;
      of CVD into nine categories, namely coronary artery diseases, aortic diseases, peripheral&#xD;
      artery diseases, myocardial diseases, unclassified or any-cause heart failure, valvular heart&#xD;
      diseases, arrhythmias, congenital CVD, and others. For example, if a patient had a couple of&#xD;
      diseases, he or she had a plural category. Cerebrovascular diseases were included in the&#xD;
      category of 'others' because of the mixed cause for the diseases such as embolic strokes,&#xD;
      lacunar infarction, cardio-embolic strokes, and hemorrhagic strokes, etc. Atherosclerotic CVD&#xD;
      were defined by the presence of one or more of the following three diseases: coronary artery&#xD;
      diseases, aortic diseases and peripheral artery diseases. With regard to the detail of&#xD;
      coronary artery diseases, there were acute coronary syndromes, previous myocardial infarction&#xD;
      and stable ischemic heart diseases. Aortic diseases consisted of acute aortic syndromes and&#xD;
      aortic aneurysms. Non-atherosclerotic CVD were defined as any CVD except atherosclerotic and&#xD;
      congenital CVD. The SHIP cohort study also handled to define lifestyle related diseases when&#xD;
      confirmed a diagnosis of one or more of the presence of hypertension, dyslipidemia, diabetes&#xD;
      mellitus and chronic kidney disease in accordance with the universal criteria. A history of&#xD;
      tobacco smoking was also identified. Among a total of 36,151 patients with any CVD enrolled&#xD;
      in the SHIP cohort study between June 2006 and July 2014, we excluded 245 patients who had&#xD;
      already been diagnosed with any cancers at the time of enrollment in the SHIP cohort study,&#xD;
      and 3,811 patients with congenital CVD including Marfan syndrome. Thus, we analyzed a total&#xD;
      of 32,095 consecutive patients with acquired CVD in the present study.Our study was conducted&#xD;
      in two steps to assess an incidence of cancers in patients with acquired CVD. The first step&#xD;
      consisted of a comparison between those with atherosclerotic CVD and non-atherosclerotic CVD&#xD;
      with regard to an incidence of cancers. The second step determined the association between a&#xD;
      singular presence versus a plural presence of atherosclerotic CVD and an incidence of&#xD;
      cancers.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2006</start_date>
  <completion_date type="Actual">July 2014</completion_date>
  <primary_completion_date type="Actual">July 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1020 Days</target_duration>
  <primary_outcome>
    <measure>incidence of cancers</measure>
    <time_frame>July, 2014</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>any cause mortality</measure>
    <time_frame>July, 2014</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">32095</enrollment>
  <condition>Cancer</condition>
  <arm_group>
    <arm_group_label>Atherosclerotic CVD</arm_group_label>
    <description>Atherosclerotic cardiovascular diseases (CVD) included coronary artery diseases, aortic diseases and peripheral artery diseases.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-atherosclerotic CVD</arm_group_label>
    <description>Non-atherosclerotic cardiovascular diseases (CVD) were any CVD except atherosclerotic CVD and congenital CVD.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>incidence of cancers</intervention_name>
    <description>With a continuous surveillance system to track all subsequent incidents of CVD and/or non-CVD via direct contact in the outpatient department, hospital records, and a mailed questionnaire at least once a year, an incidence of cancers was identified.</description>
    <arm_group_label>Atherosclerotic CVD</arm_group_label>
    <arm_group_label>Non-atherosclerotic CVD</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        A total of 36,151 patients (58% male, 61±23 years) with any cardiovascular diseases (CVD)&#xD;
        enrolled in the SHIP cohort study between June 2006 and July 2014.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Among a total of 36,151 patients with any CVD enrolled in the SHIP cohort study&#xD;
             between June 2006 and July 2014, we analyzed a total of 32,095 consecutive patients&#xD;
             with acquired CVD in the present study after excluding 4,056 patients with known&#xD;
             cancers and/or congenital CVD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  We excluded 245 patients who had already been diagnosed with any cancers at the time&#xD;
             of enrollment in the SHIP cohort study, and 3,811 patients with congenital CVD&#xD;
             including Marfan syndrome.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Makoto Suzuki, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sakakibara Heart Institute</affiliation>
  </overall_official>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 26, 2016</study_first_submitted>
  <study_first_submitted_qc>December 26, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>December 28, 2016</last_update_submitted>
  <last_update_submitted_qc>December 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 30, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sakakibara Heart Institute</investigator_affiliation>
    <investigator_full_name>Makoto Suzuki</investigator_full_name>
    <investigator_title>Principal Investigator, Department of Cardiology</investigator_title>
  </responsible_party>
  <keyword>Atherosclerotic cardiovascular diseases, cancers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cardiovascular Diseases</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03005834
org study id: SHIP01
nct id: NCT03005834
lead sponsor: 
has dmc: No
Because of the genetic and traditional commonalities between the underlying causes of
      atherosclerotic cardiovascular diseases (CVD) and cancers, we hypothesized that patients with
      atherosclerotic CVD may have a high incidence of cancers when compared with those with
      non-atherosclerotic CVD. To address this hypothesis, we investigated longitudinal clinical
      outcomes in a total of 32,095 consecutive patients with CVD enrolled in the Sakakibara Health
      Integrative Profile (SHIP) cohort study which was launched in 2006 for the purpose of
      improving healthy life expectancy in patients with CVD in our institute.
The SHIP cohort study was launched in 2006 for the purpose of improving healthy life
      expectancy in patients with any cardiovascular diseases (CVD) who were admitted to the
      Sakakibara Heart Institute. The study used a continuous surveillance system to track all
      subsequent incidents of CVD and/or non-CVD including cancers, via direct contact in the
      outpatient department, hospital records, and a mailed questionnaire at least once a year.
      Organ sites of cancers were also identified whenever possible. The study sorted any diagnoses
      of CVD into nine categories, namely coronary artery diseases, aortic diseases, peripheral
      artery diseases, myocardial diseases, unclassified or any-cause heart failure, valvular heart
      diseases, arrhythmias, congenital CVD, and others. For example, if a patient had a couple of
      diseases, he or she had a plural category. Cerebrovascular diseases were included in the
      category of 'others' because of the mixed cause for the diseases such as embolic strokes,
      lacunar infarction, cardio-embolic strokes, and hemorrhagic strokes, etc. Atherosclerotic CVD
      were defined by the presence of one or more of the following three diseases: coronary artery
      diseases, aortic diseases and peripheral artery diseases. With regard to the detail of
      coronary artery diseases, there were acute coronary syndromes, previous myocardial infarction
      and stable ischemic heart diseases. Aortic diseases consisted of acute aortic syndromes and
      aortic aneurysms. Non-atherosclerotic CVD were defined as any CVD except atherosclerotic and
      congenital CVD. The SHIP cohort study also handled to define lifestyle related diseases when
      confirmed a diagnosis of one or more of the presence of hypertension, dyslipidemia, diabetes
      mellitus and chronic kidney disease in accordance with the universal criteria. A history of
      tobacco smoking was also identified. Among a total of 36,151 patients with any CVD enrolled
      in the SHIP cohort study between June 2006 and July 2014, we excluded 245 patients who had
      already been diagnosed with any cancers at the time of enrollment in the SHIP cohort study,
      and 3,811 patients with congenital CVD including Marfan syndrome. Thus, we analyzed a total
      of 32,095 consecutive patients with acquired CVD in the present study.Our study was conducted
      in two steps to assess an incidence of cancers in patients with acquired CVD. The first step
      consisted of a comparison between those with atherosclerotic CVD and non-atherosclerotic CVD
      with regard to an incidence of cancers. The second step determined the association between a
      singular presence versus a plural presence of atherosclerotic CVD and an incidence of
      cancers.
observational model: Cohort
time perspective: Prospective
measure: incidence of cancers
time frame: July, 2014
measure: any cause mortality
time frame: July, 2014
arm group label: Atherosclerotic CVD
description: Atherosclerotic cardiovascular diseases (CVD) included coronary artery diseases, aortic diseases and peripheral artery diseases.
arm group label: Non-atherosclerotic CVD
description: Non-atherosclerotic cardiovascular diseases (CVD) were any CVD except atherosclerotic CVD and congenital CVD.
intervention type: Other
intervention name: incidence of cancers
description: With a continuous surveillance system to track all subsequent incidents of CVD and/or non-CVD via direct contact in the outpatient department, hospital records, and a mailed questionnaire at least once a year, an incidence of cancers was identified.
arm group label: Atherosclerotic CVD
arm group label: Non-atherosclerotic CVD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Makoto Suzuki, MD
role: Principal Investigator
affiliation: Sakakibara Heart Institute
responsible party type: Principal Investigator
investigator affiliation: Sakakibara Heart Institute
investigator full name: Makoto Suzuki
investigator title: Principal Investigator, Department of Cardiology
mesh term: Cardiovascular Diseases
mesh term: Atherosclerosis
sharing ipd: No