Coronary Artery DiseaseSingCLOUDNCT03760705
Singapore Cardiac Longitudinal Outcomes Database
An observational study of Coronary Artery Disease and Congestive Heart Failure, run by National Heart Centre Singapore at 13 sites in Singapore.
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. Read more about this study
- Who is it for?
- Ages 21 to 120 years
- Conditions the study is for
- Coronary Artery Disease, Congestive Heart Failure, Atrial Fibrillation
- What is being tested?
- Data Collection
- How many people
- 7,205,000 participants
- Where
- 13 sitesSingapore
- Study dates
- 5 Jul 2013to Dec 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 120 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- non-Singaporeans
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Singapore13 sites
National University Hospital (Singapore) Pte Ltd
Singapore, 119074
National Healthcare Group Polyclinics
Singapore, 138543
SingHealth Polyclinics
Singapore, 150167
Alexandra Hospital
Singapore, 159964
Singapore General Hospital
Singapore, 169608
National Heart Centre Singapore
Singapore, 169609
Ministry of Health
Singapore, 169854
Tan Tock Seng Hospital Pte Ltd
Singapore, 308433
Changi General Hospital
Singapore, 529889
National University Polyclinics
Singapore, 609606
Ng Teng Fong General Hospital
Singapore, 609606
Khoo Teck Puat Hospital
Singapore, 768828
Sengkang Hospital
Singapore
About this study
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
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.
Read the 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.
- Being tested
- Data Collection
- Keywords
- CAD, CHF, AF, SingCLOUD, Cardiovascular, Retrospective, BRAIN, HDG, Database
- Medical subject headings
- Coronary Artery Disease, Heart Failure, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data CollectionOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Coronary Artery Disease | 1. Clinical data collected by Singapore Cardiac Data Bank (SCDB)
2. Clinical, administrative, pharmacy, financial data collected by each participating hospital
3. Administrative data collected by the Ministry of Health Receives: Other: Data Collection | |
| Heart Failure | 1. Clinical data collected by Singapore Cardiac Data Bank (SCDB)
2. Clinical, administrative, pharmacy, financial data collected by each participating hospital
3. Administrative data collected by the Ministry of Health Receives: Other: Data Collection | |
| Atrial Fibrillation | 1. Clinical data collected by Singapore Cardiac Data Bank (SCDB)
2. Clinical, administrative, pharmacy, financial data collected by each participating hospital
3. Administrative data collected by the Ministry of Health Receives: Other: Data Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 3 year
Secondary outcomes (3)
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
Measured: 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
Measured: 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
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start5 Jul 2013
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 7,205,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Singapore, Changi General Hospital, National University Hospital, Singapore, Singapore General Hospital, Tan Tock Seng Hospital, Khoo Teck Puat Hospital, SingHealth Polyclinics, National Healthcare Group, Singapore, Ng Teng Fong General Hospital, Sengkang General Hospital, National University Polyclinics, Alexandra Hospital
- Responsible party
- Sponsor
- Investigators
- Khung Keong Yeo, Principal investigator, National Heart Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760705
- Sponsor's protocol ID
- CIRB/2013-391/C
- Acronym
- SingCLOUD
- Status last verified
- Dec 2019
- First submitted
- 4 Apr 2018
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03760705
- Acronym / sponsor ID
- SingCLOUD / CIRB/2013-391/C
- Keywords
- CAD, CHF, AF, SingCLOUD, Cardiovascular, Retrospective, BRAIN, HDG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 7,205,000 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Collaborators
- Ministry of Health, Singapore, Changi General Hospital, National University Hospital, Singapore, Singapore General Hospital, Tan Tock Seng Hospital, Khoo Teck Puat Hospital, SingHealth Polyclinics, National Healthcare Group, Singapore, Ng Teng Fong General Hospital, Sengkang General Hospital, National University Polyclinics, Alexandra Hospital
- Study start
- 5 Jul 2013 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 30 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Coronary Artery Disease | – | Other: Data Collection1. Clinical data collected by Singapore Cardiac Data Bank (SCDB) 2. Clinical, administrative, pharmacy, financial data collected by each participating hospital 3. Administrative data collected by the Ministry of Health |
| Heart Failure | – | Other: Data Collection1. Clinical data collected by Singapore Cardiac Data Bank (SCDB) 2. Clinical, administrative, pharmacy, financial data collected by each participating hospital 3. Administrative data collected by the Ministry of Health |
| Atrial Fibrillation | – | Other: Data Collection1. Clinical data collected by Singapore Cardiac Data Bank (SCDB) 2. Clinical, administrative, pharmacy, financial data collected by each participating hospital 3. Administrative data collected by the Ministry of Health |
Who may qualify
- Ages
- 21 to 120 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- non-Singaporeans
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data Collection1. Collection of data as detailed below: 1. Clinical data collected by SCDB 2. Clinical, administrative, pharmacy, financial data collected by each participating hospital 3. Administrative data collected by MOH 2. Data will be extracted and anonymized on a secure healthcare analytics platform 3. Collaboration with the MOH for collection of administrative and financial data 4. Analysis on how healthcare behavior is affected by education, socioeconomic level and other social or cultural factors. 5. 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. | Other | Atrial Fibrillation, Coronary Artery Disease, Heart Failure |
Primary outcome
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
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
3 secondary outcomes
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Khung Keong Yeo principal investigator
National Heart Centre Singapore
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease and Congestive Heart Failure, run by National Heart Centre Singapore at 13 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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 (time frame: 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2020.