Singapore Cardiac Longitudinal Outcomes Database

Coronary Artery Disease Clinical Trial

— SingCLOUD  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03760705
• Other study ID #: CIRB/2013-391/C
• Status: Active, not recruiting
• Start date: July 5, 2013
• Est. completion date: December 2025

Study information

• Verified date: December 2019
• Source: National Heart Centre Singapore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7205000
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Gender: All
• Age group: 21 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation
• Congestive Heart Failure
• Coronary Artery Disease
• Coronary Disease
• Heart Failure
• Myocardial Ischemia

Intervention

Other:
• Data Collection
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.

Locations

Country	Name	City	State
Singapore	Alexandra Hospital	Singapore
Singapore	Changi General Hospital	Singapore
Singapore	Khoo Teck Puat Hospital	Singapore
Singapore	Ministry of Health	Singapore
Singapore	National Healthcare Group Polyclinics	Singapore
Singapore	National Heart Centre Singapore	Singapore
Singapore	National University Hospital (Singapore) Pte Ltd	Singapore
Singapore	National University Polyclinics	Singapore
Singapore	Ng Teng Fong General Hospital	Singapore
Singapore	Sengkang Hospital	Singapore
Singapore	Singapore General Hospital	Singapore
Singapore	SingHealth Polyclinics	Singapore
Singapore	Tan Tock Seng Hospital Pte Ltd	Singapore

Sponsors (13)

Lead Sponsor	Collaborator
National Heart Centre Singapore	Alexandra Hospital, Singapore, Changi General Hospital, Khoo Teck Puat Hospital, Ministry of Health, Singapore, National Healthcare Group, Singapore, National University Hospital, Singapore, National University Polyclinics, Ng Teng Fong General Hospital, Sengkang General Hospital, Singapore General Hospital, SingHealth Polyclinics, Tan Tock Seng Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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