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Active, Not Recruiting

NCT Number: NCT03507309

NIHR CV Health Informatics Collaborative

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All patients presenting to one of the collaborating hospitals.

Exclusion criteria

  • Nil

Treatment and study plan

Primary outcomes

  1. Mortality, All-cause

    Time frame: Hospital admission to 3 years follow-up

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

Secondary outcomes

  1. Acute Revascularisation

    Time frame: 3 months follow-up

    Acute revascularisation will be defined as having PCI or CABG in the time window between 48 hours before and 3 months after the first troponin measurement. This will account for patients who had revascularisation, in particular PCI, as an emergency prior to their first troponin blood test and to capture revascularisation, in particular CABG, performed as an outpatient following their index admission.

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Collaborators

  • Blackpool Teaching Hospitals NHS Foundation Trust
  • Guy's and St Thomas' NHS Foundation Trust
  • King's College Hospital NHS Trust
  • Manchester University NHS Foundation Trust
  • Oxford University Hospitals NHS Trust
  • The Leeds Teaching Hospitals NHS Trust
  • University College London Hospitals
  • University Hospital Birmingham NHS Foundation Trust
  • University Hospital Southampton NHS Foundation Trust
  • University Hospitals Bristol and Weston NHS Foundation Trust
  • University Hospitals, Leicester

Registry information

Official study title

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

Acronym: NHIC-CV

Important dates

Study start
2016
Primary completion
2028
Study completion
2028
First posted
Apr 25, 2018
Registry last updated
Oct 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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