- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04510441
Artificial Intelligence-assisted Diagnosis and Prognostication in COVID-19 Using Electrocardiograms (AI-COV-19)
Artificial Intelligence-assisted Diagnosis and Prognostication in COVID-19 Using Electrocardiograms and Imaging
Study Overview
Detailed Description
Coronavirus Disease 2019 (COVID-19) has been widespread worldwide since December 2019. It is highly contagious, and severe cases can lead to acute respiratory distress or multiple organ failure and ultimately death. The disease can be confirmed by using the reverse-transcription polymerase chain reaction (RT-PCR) test. ECGs, Chest x-rays and CT scans are rich sources of data that provide insight to disease that otherwise would not be available.
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).
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, HA1 3UJ
- Recruiting
- London North West University Healthcare NHS Trust
-
Contact:
- Jaymin Shah, MRCP PhD
- Phone Number: 02075949832
- Email: jaymin.shah@nhs.net
-
London, United Kingdom, TW7 6AF
- Recruiting
- Chelsea And Westminster Hospital NHS Foundation Trust
-
Contact:
- Emmanuel Ako, MRCP PhD
- Phone Number: e 02075949832
- Email: Emmanuelle.Ako@chelwest.nhs.uk
-
Contact:
- Abtehale Al-Hussaini, MRCP PhD
- Phone Number: e 02075949832
- Email: abtehale.Al-hussaini@chelwest.nhs.uk
-
London, United Kingdom, W12 0NN
- Active, not recruiting
- Imperial College London (Hammersmith campus)
-
London, United Kingdom, W2 1NY
- Recruiting
- St Mary's Hospital
-
Contact:
- Fu Siong Ng
- Phone Number: 02075943614
- Email: f.ng@imperial.ac.uk
-
Contact:
- Kiran Patel
- Phone Number: 02075943614
- Email: kiran.patel@imperial.ac.uk
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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.
Description
Inclusion Criteria:
- have ECGs, Chest x-ray and/or chest CT imaging (with or without contrast)
- 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:
- Suboptimal ECGs, chest radiographs or CT studies for deep learning methods due to artefacts including severe
- 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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of machine learning to be able to predict outcome of coronavirus (COVID-19) infection
Time Frame: At the end of data analyses, approximately 1 year
|
Accuracy with which computer based analysis (machine learning) can diagnose and/or prognosticate Covid-19 Number of Participants With COVID19 who died or survived following hospital admission
|
At the end of data analyses, approximately 1 year
|
Accuracy of machine learning to be able to predict prognosis of coronavirus (COVID-19) infection
Time Frame: At the end of data analyses, approximately 1 year
|
Number of participants who required invasive vs non-invasive ventilation vs ward-based care vs died
|
At the end of data analyses, approximately 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of machine learning to be able to predict cardiac involvement of coronavirus (COVID-19) infection
Time Frame: At the end of data analyses, approximately 1 year
|
Number of participants who had COVID19-related heart problems.
|
At the end of data analyses, approximately 1 year
|
Accuracy of machine learning vs human assessment to diagnose coronavirus (COVID-19) infection
Time Frame: At the end of data analyses, approximately 1 year
|
Number of participants that can be identified as having COVID19 using machine learning vs human or other clinical test or assessment
|
At the end of data analyses, approximately 1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20HH5967
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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