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COVID-19 Stroke Apical Lung Examination Study

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ClinicalTrials.gov Identifier: NCT04640428
Recruitment Status : Recruiting
First Posted : November 23, 2020
Last Update Posted : May 27, 2021
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
King's College Hospital NHS Trust

Study Description
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Brief Summary:
Multi-centre prospective study evaluating computed tomography angiography studies performed for stroke patients as a diagnostic and prognostic imaging biomarker.

Condition or disease
Covid19 Stroke, Acute Stroke, Ischemic Stroke Hemorrhagic

Detailed Description:
Diagnosis of coronavirus disease 2019 (COVID-19) relies on clinical features and reverse-transcriptase polymerase chain reaction (RT-PCR) testing. The latter is constrained by limited sensitivity and a timescale of hours to yield results, with no point-of-care test widely available. A dedicated computed tomography study of the chest is likely to be more sensitive than RT-PCR for COVID-19. Carotid computed tomography angiography (CTA) is a routine acute stroke investigation and includes the lung apices. We aim to assess the lung apices on CTA for ground glass opacification and compare this with COVID-19 RT-PCR test results and clinical outcome measures.
Study Design
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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: COVID-19 Stroke Apical Lung Examination Study - A Multi-centre Prospective Study
Actual Study Start Date : July 10, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : October 31, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Accuracy of the computed tomography angiography biomarker relative to the COVID-19 RT-PCR test [ Time Frame: 1 month ]
    Defined by sensitivity, specificity, positive and negative predictive values


Secondary Outcome Measures :
  1. Prognostic value of the computed tomography biomarker [ Time Frame: 1 month ]
    Defined by its relationship with 30 day mortality and modified rankin scale following treatment


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All adult patients presenting to participating centres with clinical features of acute ischaemic stroke undergoing investigation with computed tomography angiography at presentation.
Criteria

Inclusion Criteria:

All adult patients presenting with clinical features of acute ischaemic stroke undergoing investigation with computed tomography angiography at presentation.

Exclusion Criteria:

Poor image quality. No radiologist report available. Computed tomography angiography performed in a non-acute setting.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04640428


Contacts
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Contact: Nathan Chan, FRCR +44(0)7508192126 covidsalesresearch@gmail.com
Contact: Tom Booth, FRCR +44(0)2032993279 thomas.booth@kcl.ac.uk

Locations
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United Kingdom
Royal United Hospitals Bath NHS Foundation Trust Recruiting
Bath, United Kingdom
Principal Investigator: Tim Burkett         
North Bristol NHS Trust Recruiting
Bristol, United Kingdom
Contact: Teo         
Principal Investigator: Teo Lopez-Bernal         
University Hospitals Bristol NHS Foundation Trust Recruiting
Bristol, United Kingdom
Principal Investigator: Teo Lopez-Bernal         
Frimley Health NHS Foundation Trust Recruiting
Camberley, United Kingdom
Principal Investigator: Robert Barker         
Cardiff and Vale University Health Board Recruiting
Cardiff, United Kingdom
Principal Investigator: Saptarshi Mukherjee         
University Hospitals Coventry and Warwickshire NHS Trust Recruiting
Coventry, United Kingdom
Principal Investigator: Ajit Kishore         
Leeds Teaching Hospitals NHS Trust Recruiting
Leeds, United Kingdom
Principal Investigator: Jim Zhong         
Guy's and St Thomas' NHS Foundation Trust Recruiting
London, United Kingdom
Principal Investigator: Virjen Patel         
Imperial College Healthcare NHS Foundation Trust Recruiting
London, United Kingdom
Principal Investigator: Jack Garnham         
King's College Hospital NHS FT (KCH) Recruiting
London, United Kingdom
Contact: Thomas Booth    02078489568    thomas.booth@kcl.ac.uk   
King's College Hospital NHS FT (PRUH) Recruiting
London, United Kingdom
Principal Investigator: Priyan Tantrige         
University College London NHS Foundation Trust Recruiting
London, United Kingdom
Principal Investigator: Indran Davagnanam         
Sponsors and Collaborators
King's College Hospital NHS Trust
National Institute for Health Research, United Kingdom
More Information
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Responsible Party: King's College Hospital NHS Trust
ClinicalTrials.gov Identifier: NCT04640428    
Other Study ID Numbers: COVID SALES 2
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: May 27, 2021
Last Verified: May 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by King's College Hospital NHS Trust:
COVID
stroke
CT
CTA
Additional relevant MeSH terms:
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COVID-19
Stroke
Ischemic Stroke
Hemorrhagic Stroke
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
 Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases