<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/NCT03760705</url>
  </required_header>
  <id_info>
    <org_study_id>CIRB/2013-391/C</org_study_id>
    <nct_id>NCT03760705</nct_id>
  </id_info>
  <brief_title>Singapore Cardiac Longitudinal Outcomes Database</brief_title>
  <acronym>SingCLOUD</acronym>
  <official_title>Long-term Clinical Outcomes, Cost-of-care, Clinical Characteristics, Re-admission Rates, Outpatient Care and Mortality in Patients With Coronary Artery Disease or Congestive Heart Failure in Singapore</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Heart Centre Singapore</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Changi General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National University Hospital, Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Singapore General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Tan Tock Seng Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Khoo Teck Puat Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>SingHealth Polyclinics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Healthcare Group, Singapore</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Ng Teng Fong General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Sengkang General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>National University Polyclinics</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Alexandra Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>National Heart Centre Singapore</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The research project aims to perform data extraction, integration and analysis across&#xD;
      multiple clinical, administrative, financial and pharmacy databases in the participating&#xD;
      institutions. The key data components will include clinical cardiovascular specific data,&#xD;
      procedural data, financial and administrative data (e.g. cost of medications and supplies,&#xD;
      length of stay, diagnosis codes etc.), short-to-long term clinical outcomes (including&#xD;
      hospital re-admissions, cardiovascular events, death), and quality-of-care indices (e.g.&#xD;
      compliance to guideline-recommended therapy and medications). The research project will&#xD;
      involve all patients proven and/or suspected with coronary artery disease (CAD), congestive&#xD;
      heart failure (CHF) and atrial fibrillation (AF) admitted to National Heart Centre Singapore&#xD;
      (NHCS) and NUH.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The research project is initiated by NHCS and its participating institutions include Ministry&#xD;
      of Health (MOH), as well as National University Hospital (Singapore) Pte Ltd (NUH), Changi&#xD;
      General Hospital (CGH), Khoo Teck Puat Hospital (KTPH), Singapore General Hospital (SGH), Tan&#xD;
      Tock Seng Hospital (TTSH), Ng Teng Fong General Hospital (NTFGH) , SingHealth Polyclinics,&#xD;
      National Healthcare Group Polyclinics (NHGP), Sengkang Hospital (SKH), National University&#xD;
      Polyclinics (NUP), and Alexandra Hospital (AH).&#xD;
&#xD;
      The research project will leverage on the Health Data Grid (HDG) pilot project, now known as&#xD;
      Business Research Analytics Insights Network (BRAIN). BRAIN will be a virtual repository that&#xD;
      will enable access to anonymised and merged data from disparate databases at multiple&#xD;
      institutions. The structures of BRAIN will preserve patients' privacy and confidentiality,&#xD;
      ensure IT security and allow access only by authorised persons. The BRAIN pilot project will&#xD;
      be co-funded by MOH and the Infocommunication Media Development Authority of Singapore&#xD;
      (IMDA). To avoid doubt, after the BRAIN pilot project, a separate approval from the&#xD;
      appropriate stakeholders will have to be sought for further funding of the operating costs of&#xD;
      the BRAIN, regardless of whether the value of the BRAIN has been demonstrated during the&#xD;
      BRAIN pilot project. There is no direct cost involved in the research project.&#xD;
&#xD;
      For the research project, MOH will contribute administrative data from the Registry of Births&#xD;
      and Deaths, Casemix &amp; Subvention, the Mediclaim, and Omnibus databases, and the other&#xD;
      participating institutions will contribute the data from the National Electronic Health&#xD;
      Records (NEHR), Electronic Health Intelligence System (eHIntS) and Enterprise Data Warehouse&#xD;
      (EDW) to BRAIN. Only anonymised data from BRAIN will be utilised for the research project.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">July 5, 2013</start_date>
  <completion_date type="Anticipated">December 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2025</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>Other</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>The primary outcome measure will be to assess the total number of patients who passed away due to any cause at the 1-year time point</measure>
    <time_frame>1 year</time_frame>
    <description>Mortality</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The primary outcome measure will be to assess the total number of patients who passed away due to any cause at the 2-year time point</measure>
    <time_frame>2 year</time_frame>
    <description>Mortality</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The primary outcome measure will be to assess the total number of patients who passed away due to any cause at the 3-year time point</measure>
    <time_frame>3 year</time_frame>
    <description>Mortality</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The secondary outcome measure will be to assess the total number of patients who had major adverse cardiac event (MACE) due to any cause at the 1-year time point</measure>
    <time_frame>1 year</time_frame>
    <description>Myocardial Infarction (MI), Stroke, CHF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The secondary outcome measure will be to assess the total number of patients who had MACE due to any cause at the 2-year time point</measure>
    <time_frame>2 year</time_frame>
    <description>MI, Stroke, CHF</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The secondary outcome measure will be to assess the total number of patients who had MACE due to any cause at the 3-year time point</measure>
    <time_frame>3 year</time_frame>
    <description>MI, Stroke, CHF</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">7205000</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Congestive Heart Failure</condition>
  <condition>Atrial Fibrillation</condition>
  <arm_group>
    <arm_group_label>Coronary Artery Disease</arm_group_label>
    <description>Clinical data collected by Singapore Cardiac Data Bank (SCDB)&#xD;
Clinical, administrative, pharmacy, financial data collected by each participating hospital&#xD;
Administrative data collected by the Ministry of Health</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heart Failure</arm_group_label>
    <description>Clinical data collected by Singapore Cardiac Data Bank (SCDB)&#xD;
Clinical, administrative, pharmacy, financial data collected by each participating hospital&#xD;
Administrative data collected by the Ministry of Health</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Atrial Fibrillation</arm_group_label>
    <description>Clinical data collected by Singapore Cardiac Data Bank (SCDB)&#xD;
Clinical, administrative, pharmacy, financial data collected by each participating hospital&#xD;
Administrative data collected by the Ministry of Health</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data Collection</intervention_name>
    <description>Collection of data as detailed below:&#xD;
Clinical data collected by SCDB&#xD;
Clinical, administrative, pharmacy, financial data collected by each participating hospital&#xD;
Administrative data collected by MOH&#xD;
Data will be extracted and anonymized on a secure healthcare analytics platform&#xD;
Collaboration with the MOH for collection of administrative and financial data&#xD;
Analysis on how healthcare behavior is affected by education, socioeconomic level and other social or cultural factors.&#xD;
Statistical Analysis by the bio statistical team. This team will be responsible for collecting and merging the collected data and will also ensure the quality of the data.</description>
    <arm_group_label>Atrial Fibrillation</arm_group_label>
    <arm_group_label>Coronary Artery Disease</arm_group_label>
    <arm_group_label>Heart Failure</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The participating institutions will include National Heart Centre Singapore, National&#xD;
        University Heart Centre, Singapore General Hospital, Tan Tock Seng Hospital, Changi General&#xD;
        Hospital, Khoo Teck Puat Hospital, Ng Teng Fong General Hospital, Singhealth Polyclinics,&#xD;
        National Healthcare Group Polyclinics, Sengkang General Hospital, National University&#xD;
        Polyclinics, Alexandra Hospital, and the Ministry of Health Health Services Research&#xD;
        Division.&#xD;
&#xD;
        All patients who present to a healthcare institution with either CAD or suspected CAD&#xD;
        (including chest pain); CHF or suspected CHF; AF or suspected AF&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients who present to a healthcare institution with either CAD or suspected CAD&#xD;
             (including chest pain); CHF or suspected CHF; AF or suspected AF&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  non-Singaporeans&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>120 Years</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Khung Keong Yeo</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Heart Centre Singapore</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National University Hospital (Singapore) Pte Ltd</name>
      <address>
        <city>Singapore</city>
        <zip>119074</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Healthcare Group Polyclinics</name>
      <address>
        <city>Singapore</city>
        <zip>138543</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SingHealth Polyclinics</name>
      <address>
        <city>Singapore</city>
        <zip>150167</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alexandra Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>159964</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Singapore General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>169608</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Heart Centre Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>169609</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ministry of Health</name>
      <address>
        <city>Singapore</city>
        <zip>169854</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tan Tock Seng Hospital Pte Ltd</name>
      <address>
        <city>Singapore</city>
        <zip>308433</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Changi General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>529889</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National University Polyclinics</name>
      <address>
        <city>Singapore</city>
        <zip>609606</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ng Teng Fong General Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>609606</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Khoo Teck Puat Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>768828</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sengkang Hospital</name>
      <address>
        <city>Singapore</city>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Singapore</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>April 4, 2018</study_first_submitted>
  <study_first_submitted_qc>November 29, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 30, 2018</study_first_posted>
  <last_update_submitted>March 20, 2020</last_update_submitted>
  <last_update_submitted_qc>March 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 24, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CAD</keyword>
  <keyword>CHF</keyword>
  <keyword>AF</keyword>
  <keyword>SingCLOUD</keyword>
  <keyword>Cardiovascular</keyword>
  <keyword>Retrospective</keyword>
  <keyword>BRAIN</keyword>
  <keyword>HDG</keyword>
  <keyword>Database</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Failure</mesh_term>
    <mesh_term>Atrial Fibrillation</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</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/NCT03760705
org study id: CIRB/2013-391/C
nct id: NCT03760705
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The research project aims to perform data extraction, integration and analysis across
      multiple clinical, administrative, financial and pharmacy databases in the participating
      institutions. The key data components will include clinical cardiovascular specific data,
      procedural data, financial and administrative data (e.g. cost of medications and supplies,
      length of stay, diagnosis codes etc.), short-to-long term clinical outcomes (including
      hospital re-admissions, cardiovascular events, death), and quality-of-care indices (e.g.
      compliance to guideline-recommended therapy and medications). The research project will
      involve all patients proven and/or suspected with coronary artery disease (CAD), congestive
      heart failure (CHF) and atrial fibrillation (AF) admitted to National Heart Centre Singapore
      (NHCS) and NUH.
The research project is initiated by NHCS and its participating institutions include Ministry
      of Health (MOH), as well as National University Hospital (Singapore) Pte Ltd (NUH), Changi
      General Hospital (CGH), Khoo Teck Puat Hospital (KTPH), Singapore General Hospital (SGH), Tan
      Tock Seng Hospital (TTSH), Ng Teng Fong General Hospital (NTFGH) , SingHealth Polyclinics,
      National Healthcare Group Polyclinics (NHGP), Sengkang Hospital (SKH), National University
      Polyclinics (NUP), and Alexandra Hospital (AH).

      The research project will leverage on the Health Data Grid (HDG) pilot project, now known as
      Business Research Analytics Insights Network (BRAIN). BRAIN will be a virtual repository that
      will enable access to anonymised and merged data from disparate databases at multiple
      institutions. The structures of BRAIN will preserve patients' privacy and confidentiality,
      ensure IT security and allow access only by authorised persons. The BRAIN pilot project will
      be co-funded by MOH and the Infocommunication Media Development Authority of Singapore
      (IMDA). To avoid doubt, after the BRAIN pilot project, a separate approval from the
      appropriate stakeholders will have to be sought for further funding of the operating costs of
      the BRAIN, regardless of whether the value of the BRAIN has been demonstrated during the
      BRAIN pilot project. There is no direct cost involved in the research project.

      For the research project, MOH will contribute administrative data from the Registry of Births
      and Deaths, Casemix & Subvention, the Mediclaim, and Omnibus databases, and the other
      participating institutions will contribute the data from the National Electronic Health
      Records (NEHR), Electronic Health Intelligence System (eHIntS) and Enterprise Data Warehouse
      (EDW) to BRAIN. Only anonymised data from BRAIN will be utilised for the research project.
observational model: Cohort
time perspective: Other
measure: The primary outcome measure will be to assess the total number of patients who passed away due to any cause at the 1-year time point
time frame: 1 year
description: Mortality
measure: The primary outcome measure will be to assess the total number of patients who passed away due to any cause at the 2-year time point
time frame: 2 year
description: Mortality
measure: The primary outcome measure will be to assess the total number of patients who passed away due to any cause at the 3-year time point
time frame: 3 year
description: Mortality
measure: The secondary outcome measure will be to assess the total number of patients who had major adverse cardiac event (MACE) due to any cause at the 1-year time point
time frame: 1 year
description: Myocardial Infarction (MI), Stroke, CHF
measure: The secondary outcome measure will be to assess the total number of patients who had MACE due to any cause at the 2-year time point
time frame: 2 year
description: MI, Stroke, CHF
measure: The secondary outcome measure will be to assess the total number of patients who had MACE due to any cause at the 3-year time point
time frame: 3 year
description: MI, Stroke, CHF
arm group label: Coronary Artery Disease
description: Clinical data collected by Singapore Cardiac Data Bank (SCDB)
Clinical, administrative, pharmacy, financial data collected by each participating hospital
Administrative data collected by the Ministry of Health
arm group label: Heart Failure
description: Clinical data collected by Singapore Cardiac Data Bank (SCDB)
Clinical, administrative, pharmacy, financial data collected by each participating hospital
Administrative data collected by the Ministry of Health
arm group label: Atrial Fibrillation
description: Clinical data collected by Singapore Cardiac Data Bank (SCDB)
Clinical, administrative, pharmacy, financial data collected by each participating hospital
Administrative data collected by the Ministry of Health
intervention type: Other
intervention name: Data Collection
description: Collection of data as detailed below:
Clinical data collected by SCDB
Clinical, administrative, pharmacy, financial data collected by each participating hospital
Administrative data collected by MOH
Data will be extracted and anonymized on a secure healthcare analytics platform
Collaboration with the MOH for collection of administrative and financial data
Analysis on how healthcare behavior is affected by education, socioeconomic level and other social or cultural factors.
Statistical Analysis by the bio statistical team. This team will be responsible for collecting and merging the collected data and will also ensure the quality of the data.
arm group label: Atrial Fibrillation
arm group label: Coronary Artery Disease
arm group label: Heart Failure
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 21 Years
maximum age: 120 Years
last name: Khung Keong Yeo
role: Principal Investigator
affiliation: National Heart Centre Singapore
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Singapore
responsible party type: Sponsor
mesh term: Heart Failure
mesh term: Atrial Fibrillation
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
sharing ipd: No