Clinical trial NCT03760705: Singapore Cardiac Longitudinal Outcomes Database
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Congestive Heart Failure
Atrial Fibrillation
Keywords: CAD
CHF
AF
SingCLOUD
Cardiovascular
Retrospective
BRAIN
HDG
Database
Lead sponsor: National Heart Centre Singapore
Sponsor class: OTHER
Collaborators: name: Ministry of Health, Singapore
name: Changi General Hospital
name: National University Hospital, Singapore
name: Singapore General Hospital
name: Tan Tock Seng Hospital
name: Khoo Teck Puat Hospital
name: SingHealth Polyclinics
name: National Healthcare Group, Singapore
name: Ng Teng Fong General Hospital
name: Sengkang General Hospital
name: National University Polyclinics
name: Alexandra Hospital
First posted: 2018-11-30
Enrollment: 7205000
Sex: ALL
Minimum age (years): 21
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
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

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.

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

Primary outcomes:
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
timeFrame: 1 year
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
timeFrame: 2 year
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
timeFrame: 3 year
Secondary outcomes:
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
timeFrame: 1 year
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
timeFrame: 2 year
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
timeFrame: 3 year
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National University Hospital (Singapore) Pte Ltd
city: Singapore
country: Singapore
facility: National Healthcare Group Polyclinics
city: Singapore
country: Singapore
facility: SingHealth Polyclinics
city: Singapore
country: Singapore
facility: Alexandra Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: National Heart Centre Singapore
city: Singapore
country: Singapore
facility: Ministry of Health
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital Pte Ltd
city: Singapore
country: Singapore
facility: Changi General Hospital
city: Singapore
country: Singapore
facility: National University Polyclinics
city: Singapore
country: Singapore
facility: Ng Teng Fong General Hospital
city: Singapore
country: Singapore
facility: Khoo Teck Puat Hospital
city: Singapore
country: Singapore
facility: Sengkang Hospital
Study officials:
affiliation: National Heart Centre Singapore
name: Khung Keong Yeo
role: PRINCIPAL_INVESTIGATOR
References: