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临床试验/NCT03760705
NCT03760705进行中(未招募)不适用

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 个研究点 分布在 1 个国家目标入组 7,205,000 人开始时间: 2013年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
7,205,000
试验地点
13
主要终点
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

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
21 Years 至 120 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • non-Singaporeans

结局指标

主要结局

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

时间窗: 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

时间窗: 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

时间窗: 1 year

Mortality

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (13)

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