NIHR CV Health Informatics Collaborative

NCT ID: NCT03507309

Last Updated: 2024-10-08

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

257948 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-01-31

Study Completion Date

2028-03-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Troponin Age Mortality Acute Coronary Syndrome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* All patients presenting to one of the collaborating hospitals.

Exclusion Criteria

* Nil
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Guy's and St Thomas' NHS Foundation Trust

OTHER

Sponsor Role collaborator

King's College Hospital NHS Trust

OTHER

Sponsor Role collaborator

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role collaborator

University College London Hospitals

OTHER

Sponsor Role collaborator

University Hospital Southampton NHS Foundation Trust

OTHER

Sponsor Role collaborator

University Hospitals, Leicester

OTHER

Sponsor Role collaborator

University Hospitals Bristol and Weston NHS Foundation Trust

OTHER

Sponsor Role collaborator

Manchester University NHS Foundation Trust

OTHER_GOV

Sponsor Role collaborator

University Hospital Birmingham NHS Foundation Trust

OTHER

Sponsor Role collaborator

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role collaborator

Blackpool Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role collaborator

Imperial College London

OTHER

Sponsor Role lead

Responsible Party

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Jamil Mayet

Professor of Cardiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jamil Mayet

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

References

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Scott JK, Johnson T, Caskey FJ, Bailey P, Selman LE, Mulla A, Glampson B, Davies J, Papdimitriou D, Woods K, O'Gallagher K, Williams B, Asselbergs FW, Mayer EK, Lee R, Herbert C, Grant SW, Curzen N, Squire I, Kharbanda R, Shah A, Perera D, Patel RS, Channon K, Mayet J, Kaura A, Ben-Shlomo Y. Association between kidney function, frailty and receipt of invasive management after acute coronary syndrome. Open Heart. 2024 Oct 9;11(2):e002875. doi: 10.1136/openhrt-2024-002875.

Reference Type DERIVED
PMID: 39384342 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35192610 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31748235 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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http://www.imperial.ac.uk/news/176510/creating-aposbig-data-from-health-records/

Creating 'big data' from health records to improve care

Other Identifiers

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16/HRA/3327

Identifier Type: OTHER

Identifier Source: secondary_id

174052

Identifier Type: -

Identifier Source: org_study_id

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