National Institute for Health Research (NIHR) Health Informatics Collaborative Troponin Study

Acute Coronary Syndrome Clinical Trial

— NHIC-Troponin  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03507309
• Other study ID #: 174052
• Secondary ID: 16/HRA/3327
• Status: Active, not recruiting
• Start date: January 2016
• Est. completion date: December 2021

Study information

• Verified date: January 2021
• Source: Imperial College London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

The NHIC Cardiovascular Project 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).

Description:

The NHIC Cardiovascular Project in the United Kingdom has been 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 257948
• Est. completion date: December 2021
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All patients presenting to one of the collaborating hospitals.

Exclusion Criteria:

• Nil

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Age
• Mortality
• Troponin

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Imperial College London	Cambridge University Hospitals NHS Foundation Trust, Guy's and St Thomas' NHS Foundation Trust, King's College Hospital NHS Trust, Oxford University Hospitals NHS Trust, University College London Hospitals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality, all-cause	Incidence of death including in-hospital, short-term and long-term mortality	Hospital admission to 3 years follow-up
Secondary	Coronary angiography	In-patient or outpatient coronary angiography	Hospital admission to 3 years follow-up
Secondary	Percutaneous coronary intervention	In-patient or outpatient percutaneous coronary intervention	Hospital admission to 3 years follow-up
Secondary	Coronary artery bypass graft	In-patient or outpatient coronary artery bypass grafting	Hospital admission to 3 years follow-up
Secondary	Readmission rate	Readmission rate after index hospital admission	Hospital discharge to 3 years follow-up

External Links

•   Creating 'big data' from health records to improve care