Singapore Cardiac Longitudinal Outcomes Database (SingCLOUD)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Atrial Fibrillation; Congestive Heart Failure
• Intervention / Treatment: Other: Data Collection

Detailed Description

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.

• Study Type: Observational
• Enrollment (Anticipated): 7205000

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 159964
    • Alexandra Hospital
  • Singapore, Singapore, 529889
    • Changi General Hospital
  • Singapore, Singapore, 169609
    • National Heart Centre Singapore
  • Singapore, Singapore, 609606
    • Ng Teng Fong General Hospital
  • Singapore, Singapore, 119074
    • National University Hospital (Singapore) Pte Ltd
  • Singapore, Singapore, 138543
    • National Healthcare Group Polyclinics
  • Singapore, Singapore, 150167
    • SingHealth Polyclinics
  • Singapore, Singapore, 169854
    • Ministry of health
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital Pte Ltd
  • Singapore, Singapore, 609606
    • National University Polyclinics
  • Singapore, Singapore, 768828
    • Khoo Teck Puat Hospital
  • Singapore, Singapore
    • Sengkang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

The participating institutions will include National Heart Centre Singapore, National University Heart Centre, Singapore General Hospital, Tan Tock Seng Hospital, Changi General Hospital, Khoo Teck Puat Hospital, Ng Teng Fong General Hospital, Singhealth Polyclinics, National Healthcare Group Polyclinics, Sengkang General Hospital, National University Polyclinics, Alexandra Hospital, and the Ministry of Health Health Services Research Division.

All patients who present to a healthcare institution with either CAD or suspected CAD (including chest pain); CHF or suspected CHF; AF or suspected AF

Description

Inclusion Criteria:

• all patients who present to a healthcare institution with either CAD or suspected CAD (including chest pain); CHF or suspected CHF; AF or suspected AF

Exclusion Criteria:

• non-Singaporeans

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Coronary Artery Disease; 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	Other: Data Collection; Collection of data as detailed below:Clinical data collected by SCDBClinical, administrative, pharmacy, financial data collected by each participating hospitalAdministrative 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.
Heart Failure; 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	Other: Data Collection; Collection of data as detailed below:Clinical data collected by SCDBClinical, administrative, pharmacy, financial data collected by each participating hospitalAdministrative 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.
Atrial Fibrillation; 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	Other: Data Collection; Collection of data as detailed below:Clinical data collected by SCDBClinical, administrative, pharmacy, financial data collected by each participating hospitalAdministrative 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Mortality	1 year
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	Mortality	2 year
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	Mortality	3 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Myocardial Infarction (MI), Stroke, CHF	1 year
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	MI, Stroke, CHF	2 year
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	MI, Stroke, CHF	3 year

Collaborators and Investigators

• Sponsor: National Heart Centre Singapore
• Collaborators: National University Hospital, Singapore; Khoo Teck Puat Hospital; Singapore General Hospital; Tan Tock Seng Hospital; Changi General Hospital; Sengkang General Hospital; National Healthcare Group, Singapore; Alexandra Hospital; Ng Teng Fong General Hospital; SingHealth Polyclinics; Ministry of Health, Singapore; National University Polyclinics
• Investigators: Principal Investigator: Khung Keong Yeo, National Heart Centre Singapore

Study record dates

Study Major Dates

• Study Start (Actual): July 5, 2013
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: April 4, 2018
• First Submitted That Met QC Criteria: November 29, 2018
• First Posted (Actual): November 30, 2018

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 20, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Cardiovascular; CHF; CAD; Database; Retrospective; AF; SingCLOUD; BRAIN; HDG
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Arrhythmias, Cardiac; Heart Failure; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Atrial Fibrillation
• Other Study ID Numbers: CIRB/2013-391/C

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No