Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-26 @ 2:10 AM
Study NCT ID:
NCT03760705
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2020-03-24
First Post:
2018-04-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Singapore Cardiac Longitudinal Outcomes Database
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}, {'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003625', 'term': 'Data Collection'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 7205000}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-07-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-03-20', 'studyFirstSubmitDate': '2018-04-04', 'studyFirstSubmitQcDate': '2018-11-29', 'lastUpdatePostDateStruct': {'date': '2020-03-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'Mortality'}, {'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', 'description': 'Mortality'}, {'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', 'description': 'Mortality'}], 'secondaryOutcomes': [{'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', 'description': 'Myocardial Infarction (MI), Stroke, CHF'}, {'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', 'description': 'MI, Stroke, CHF'}, {'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', 'description': 'MI, Stroke, CHF'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAD', 'CHF', 'AF', 'SingCLOUD', 'Cardiovascular', 'Retrospective', 'BRAIN', 'HDG', 'Database'], 'conditions': ['Coronary Artery Disease', 'Congestive Heart Failure', 'Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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).\n\nThe 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.\n\nFor 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '21 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.\n\nAll patients who present to a healthcare institution with either CAD or suspected CAD (including chest pain); CHF or suspected CHF; AF or suspected AF', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 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\n\nExclusion Criteria:\n\n* non-Singaporeans'}, 'identificationModule': {'nctId': 'NCT03760705', 'acronym': 'SingCLOUD', 'briefTitle': 'Singapore Cardiac Longitudinal Outcomes Database', 'organization': {'class': 'OTHER', 'fullName': 'National Heart Centre Singapore'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'CIRB/2013-391/C'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Coronary Artery Disease', 'description': '1. Clinical data collected by Singapore Cardiac Data Bank (SCDB)\n2. Clinical, administrative, pharmacy, financial data collected by each participating hospital\n3. Administrative data collected by the Ministry of Health', 'interventionNames': ['Other: Data Collection']}, {'label': 'Heart Failure', 'description': '1. Clinical data collected by Singapore Cardiac Data Bank (SCDB)\n2. Clinical, administrative, pharmacy, financial data collected by each participating hospital\n3. Administrative data collected by the Ministry of Health', 'interventionNames': ['Other: Data Collection']}, {'label': 'Atrial Fibrillation', 'description': '1. Clinical data collected by Singapore Cardiac Data Bank (SCDB)\n2. Clinical, administrative, pharmacy, financial data collected by each participating hospital\n3. Administrative data collected by the Ministry of Health', 'interventionNames': ['Other: Data Collection']}], 'interventions': [{'name': 'Data Collection', 'type': 'OTHER', 'description': '1. Collection of data as detailed below:\n\n 1. Clinical data collected by SCDB\n 2. Clinical, administrative, pharmacy, financial data collected by each participating hospital\n 3. Administrative data collected by MOH\n2. Data will be extracted and anonymized on a secure healthcare analytics platform\n3. Collaboration with the MOH for collection of administrative and financial data\n4. Analysis on how healthcare behavior is affected by education, socioeconomic level and other social or cultural factors.\n5. 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.', 'armGroupLabels': ['Atrial Fibrillation', 'Coronary Artery Disease', 'Heart Failure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '119074', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Hospital (Singapore) Pte Ltd', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '138543', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Healthcare Group Polyclinics', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '150167', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'SingHealth Polyclinics', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '159964', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Alexandra Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169608', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Singapore General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169609', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National Heart Centre Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '169854', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Ministry of Health', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '308433', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Tan Tock Seng Hospital Pte Ltd', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '529889', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Changi General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '609606', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'National University Polyclinics', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '609606', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Ng Teng Fong General Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'zip': '768828', 'city': 'Singapore', 'country': 'Singapore', 'facility': 'Khoo Teck Puat Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'Sengkang Hospital', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Khung Keong Yeo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Heart Centre Singapore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart Centre Singapore', 'class': 'OTHER'}, 'collaborators': [{'name': 'Ministry of Health, Singapore', 'class': 'OTHER_GOV'}, {'name': 'Changi General Hospital', 'class': 'OTHER'}, {'name': 'National University Hospital, Singapore', 'class': 'OTHER'}, {'name': 'Singapore General Hospital', 'class': 'OTHER'}, {'name': 'Tan Tock Seng Hospital', 'class': 'OTHER'}, {'name': 'Khoo Teck Puat Hospital', 'class': 'OTHER'}, {'name': 'SingHealth Polyclinics', 'class': 'OTHER'}, {'name': 'National Healthcare Group, Singapore', 'class': 'OTHER_GOV'}, {'name': 'Ng Teng Fong General Hospital', 'class': 'OTHER'}, {'name': 'Sengkang General Hospital', 'class': 'OTHER'}, {'name': 'National University Polyclinics', 'class': 'UNKNOWN'}, {'name': 'Alexandra Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}