Clinical trial NCT04510441: Artificial Intelligence-assisted Diagnosis and Prognostication in COVID-19 Using Electrocardiograms
Official title: Artificial Intelligence-assisted Diagnosis and Prognostication in COVID-19 Using Electrocardiograms and Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus
Keywords: coronavirus
electrocardiogram
artificial intelligence
COVID-19
Lead sponsor: Imperial College London
Sponsor class: OTHER
Collaborators: name: Imperial College Healthcare NHS Trust
name: Chelsea and Westminster NHS Foundation Trust
name: London North West Healthcare NHS Trust
First posted: 2020-08-12
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief summary: 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. On 11 March 2020, the WHO made the assessment that COVID-19 can be characterised as a pandemic. With the development of machine learning, deep learning based artificial intelligence (AI) technology has demonstrated tremendous success in the field of medical data analysis due to its capacity of extracting rich features from imaging and complex clinical datasets. In this study, we aim to use clinical data collected as part of routine clinical care (heart tracings, X-rays and CT scans) to train artificial intelligence and machine learning algorithms, to accurately predict the course of disease in patients with Covid-19 infection, using these datasets.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Accuracy of machine learning to be able to predict outcome of coronavirus (COVID-19) infection
timeFrame: At the end of data analyses, approximately 1 year
measure: Accuracy of machine learning to be able to predict prognosis of coronavirus (COVID-19) infection
timeFrame: At the end of data analyses, approximately 1 year
Secondary outcomes:
measure: Accuracy of machine learning to be able to predict cardiac involvement of coronavirus (COVID-19) infection
timeFrame: At the end of data analyses, approximately 1 year
measure: Accuracy of machine learning vs human assessment to diagnose coronavirus (COVID-19) infection
timeFrame: At the end of data analyses, approximately 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: London North West University Healthcare NHS Trust
city: London
country: United Kingdom
facility: Chelsea and Westminster Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Imperial College London (Hammersmith campus)
city: London
country: United Kingdom
facility: St Mary's Hospital
Study officials:
References: