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临床试验/NCT03507309
NCT03507309进行中(未招募)不适用

National Institute for Health Research (NIHR) Cardiovascular Health Informatics Collaborative

Imperial College London0 个研究点目标入组 257,948 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
257,948
主要终点
Mortality, All-cause

研究概览

简要总结

The National Institute for Health Research (NIHR) Cardiovascular Health Informatics Collaborative is an observational, multi-centre and longitudinal study of clinical data from collaborating hospitals. A dataset of the longitudinal record for patients who presented with a suspected acute coronary syndrome, characterised by the request of a troponin test, has been developed (NHIC-Troponin Study).

详细描述

The NHIC Cardiovascular Project in the United Kingdom was established to enable the sharing and repurposing of routinely captured clinical data for re-use in research. Data sharing for this study has been enabled by establishing a data sharing agreement between each of the collaborating hospitals. The data sharing agreement allows data to be shared between National Health Service (NHS) hospitals in accordance with an anonymisation and de-identification profile approved by each information governance department, ensuring that patient identities are protected. Ethics approval for each dataset has been obtained which detailed the further de-identification steps to ensure that research datasets are fully anonymised.

The cardiovascular theme clinical leads developed a standard target data model specification to capture the longitudinal record for patients who presented with a suspected acute coronary syndrome, characterised by the request of a troponin test (NHIC-Troponin Study). The data model was patient centric allowing for minor discrepancies between dataset areas such as missing discharges or test results returning outside of episodes of care. The model included 156 data points, grouped into demographics, cardiovascular risk factors, emergency department attendance and inpatient episodes, biochemistry, revascularisation and mortality. All patients were followed up on the NHS Spine Application, Summary Care Record until death or censoring on 1st April 2017.

This dataset comprised all patients who had a troponin measured at each of the five major academic centres between 2010 (2008 for University College Hospital) and 2017. The investigators identified a total of 257948 patient records who underwent troponin testing during the study period.

A Committee of Experts validates the protocol methodology and supervises the data management. A Steering Committee oversees study proposals including hypotheses, study design and statistical analyses including planned outcome measures.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • All patients presenting to one of the collaborating hospitals.

排除标准

  • 未提供

结局指标

主要结局

Mortality, All-cause

时间窗: Hospital admission to 3 years follow-up

Number of patients who died (from any cause) including in-hospital, short-term and long-term mortality

次要结局

  • Acute Revascularisation(3 months follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jamil Mayet

Professor of Cardiology

Imperial College London

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