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Clinical Trials/NCT03760705
NCT03760705
Active, not recruiting
Not Applicable

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

National Heart Centre Singapore13 sites in 1 country7,205,000 target enrollmentJuly 5, 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Coronary Artery Disease
Sponsor
National Heart Centre Singapore
Enrollment
7205000
Locations
13
Primary Endpoint
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
Status
Active, not recruiting
Last Updated
6 years ago

Overview

Brief 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.

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.

Registry
clinicaltrials.gov
Start Date
July 5, 2013
End Date
December 2025
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Mortality

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

Mortality

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

Mortality

Secondary Outcomes

  • 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(3 year)
  • 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(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(2 year)

Study Sites (13)

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