NIHR CV Health Informatics Collaborative (NHIC-CV)

National Institute for Health Research (NIHR) Cardiovascular 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).

Study Overview

• Status: Active, not recruiting
• Conditions: Mortality; Acute Coronary Syndrome; Troponin; Age

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 257948

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients with electronic records at collaborating hospitals.

Description

Inclusion Criteria:

• All patients presenting to one of the collaborating hospitals.

Exclusion Criteria:

• Nil

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Unselected cohort of patients who had a troponin measured; Patients who presented to hospital during the study period (2010-17) and had at least one troponin blood test measured.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality, All-cause	Number of patients who died (from any cause) including in-hospital, short-term and long-term mortality	Hospital admission to 3 years follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acute Revascularisation	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.	3 months follow-up

Collaborators and Investigators

• Sponsor: Imperial College London
• Collaborators: King's College Hospital NHS Trust; University College London Hospitals; The Leeds Teaching Hospitals NHS Trust; Guy's and St Thomas' NHS Foundation Trust; University Hospitals, Leicester; University Hospital Birmingham NHS Foundation Trust; Manchester University NHS Foundation Trust; University Hospital Southampton NHS Foundation Trust; University Hospitals Bristol and Weston NHS Foundation Trust; Oxford University Hospitals NHS Trust; Blackpool Teaching Hospitals NHS Foundation Trust
• Investigators: Principal Investigator: Jamil Mayet, Imperial College London

Publications and helpful links

General Publications

• Kaura A, Hartley A, Panoulas V, Glampson B, Shah ASV, Davies J, Mulla A, Woods K, Omigie J, Shah AD, Thursz MR, Elliott P, Hemmingway H, Williams B, Asselbergs FW, O'Sullivan M, Lord GM, Trickey A, Sterne JA, Haskard DO, Melikian N, Francis DP, Koenig W, Shah AM, Kharbanda R, Perera D, Patel RS, Channon KM, Mayet J, Khamis R. Mortality risk prediction of high-sensitivity C-reactive protein in suspected acute coronary syndrome: A cohort study. PLoS Med. 2022 Feb 22;19(2):e1003911. doi: 10.1371/journal.pmed.1003911. eCollection 2022 Feb.
• Kaura A, Panoulas V, Glampson B, Davies J, Mulla A, Woods K, Omigie J, Shah AD, Channon KM, Weber JN, Thursz MR, Elliott P, Hemingway H, Williams B, Asselbergs FW, O'Sullivan M, Kharbanda R, Lord GM, Melikian N, Patel RS, Perera D, Shah AM, Francis DP, Mayet J. Association of troponin level and age with mortality in 250 000 patients: cohort study across five UK acute care centres. BMJ. 2019 Nov 20;367:l6055. doi: 10.1136/bmj.l6055. Erratum In: BMJ. 2020 Jun 18;369:m2225. doi: 10.1136/bmj.m2225.

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Estimated): March 31, 2028
• Study Completion (Estimated): March 31, 2028

Study Registration Dates

• First Submitted: February 23, 2018
• First Submitted That Met QC Criteria: April 24, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Actual): October 8, 2024
• Last Update Submitted That Met QC Criteria: July 5, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome
• Other Study ID Numbers: 174052; 16/HRA/3327 (Other Identifier: Integrated Research Application System)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual electronic patient record data for all primary and secondary outcome measures will be made available.
• IPD Sharing Time Frame: Data will me made available from study completion date.
• IPD Sharing Access Criteria: Data access requests will be reviewed by a Steering Committee from the participating Biomedical Research Centres. Requesters will be required to sign a Data Access Agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No