Artificial Intelligence-assisted Diagnosis and Prognostication in COVID-19 Using Electrocardiograms
NCT ID: NCT04510441
Last Updated: 2021-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
2000 participants
OBSERVATIONAL
2020-05-26
2022-05-01
Brief Summary
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Detailed Description
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Knowing who to admit to the hospital or intensive care saves lives as it helps to mitigate resource shortages. Novel Artificial Intelligence tools such as Deep learning will allow a complex assessment of the Imaging and clinical data that could potentially help clinicians to make a faster and more accurate diagnosis, better triage patients and assess treatment response and ultimately better prediction of outcome. Our group has significant experience implementing machine learning algorithms on vast quantities of ECGs, such as from the UK Biobank, and propose to extend our techniques to data from patients with Covid-19.
This is a retrospective data study on patients with suspicious and confirmed COVID-19.
The study aims to recruit up to 2000 patients who will be referred to have ECGs, chest X-rays or CT scans at Chelsea and Westminster Hospital NHS Foundation Trust, Imperial College Healthcare NHS Trust and London North West London University Healthcare NHS Trust.
To be included in this study, the patient must:
* have ECGs, Chest x-ray and/or chest CT imaging (with or without contrast)
* laboratory Covid-19 virus nucleic acid test (RTPCR assay with throat swab samples) or clinical suspicion for Covid19 infection
* be aged \>18 years Patients with suboptimal ECGs, chest radiograph and CT studies due to artefacts will be excluded. Patients will also be excluded if the time-interval between ECGs, chest CT and the RT-PCR assay was longer than 7 days.
This study received HRA and Health and Care Research Wales (HCRW) approval on 18 May 2020 following review by Research Ethics Committee at a meeting held on 13 May 2020(Protocol number: 20HH5967; REC reference: 20/HRA/2467).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Interventions
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Nil intervention
Nil intervention; retrospective cohort study
Eligibility Criteria
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Inclusion Criteria
* positive laboratory Covid-19 virus nucleic acid test (RTPCR assay with throat swab samples) or clinical suspicion for Covid-19 infection
* be aged \>18 years
Exclusion Criteria
* motion artefacts which causes blurring of the contours of or significant artefacts due to metallic prosthesis which causes image degradation
* Time-interval between ECGs, chest CT and the RT-PCR assay was longer than 7 days
18 Years
ALL
No
Sponsors
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Imperial College Healthcare NHS Trust
OTHER
Chelsea and Westminster NHS Foundation Trust
OTHER
London North West Healthcare NHS Trust
OTHER
Imperial College London
OTHER
Responsible Party
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Locations
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London North West University Healthcare NHS Trust
London, , United Kingdom
Chelsea and Westminster Hospital NHS Foundation Trust
London, , United Kingdom
Imperial College London (Hammersmith campus)
London, , United Kingdom
St Mary's Hospital
London, , United Kingdom
Countries
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Facility Contacts
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20HH5967
Identifier Type: -
Identifier Source: org_study_id
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