COVID-19 Stroke Apical Lung Examination Study

COVID-19 Stroke Apical Lung Examination Study - A Multi-centre Prospective Study

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

Study Overview

• Status: Recruiting
• Conditions: Covid19; Stroke, Ischemic; Stroke, Acute; 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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Nathan Chan, FRCR; Phone Number: +44(0)7508192126; Email: covidsalesresearch@gmail.com
• Study Contact Backup: Name: Tom Booth, FRCR; Phone Number: +44(0)2032993279; Email: thomas.booth@kcl.ac.uk

Study Locations

• United Kingdom
  • Bath, United Kingdom
    • Recruiting
    • Royal United Hospitals Bath NHS Foundation Trust
    • Principal Investigator: Tim Burkett
  • Bristol, United Kingdom
    • Recruiting
    • North Bristol NHS Trust
    • Contact: Teo
    • Principal Investigator: Teo Lopez-Bernal
  • Bristol, United Kingdom
    • Recruiting
    • University Hospitals Bristol NHS Foundation Trust
    • Principal Investigator: Teo Lopez-Bernal
  • Camberley, United Kingdom
    • Recruiting
    • Frimley Health NHS Foundation Trust
    • Principal Investigator: Robert Barker
  • Cardiff, United Kingdom
    • Recruiting
    • Cardiff and Vale University Health Board
    • Principal Investigator: Saptarshi Mukherjee
  • Coventry, United Kingdom
    • Recruiting
    • University Hospitals Coventry and Warwickshire NHS Trust
    • Principal Investigator: Ajit Kishore
  • Leeds, United Kingdom
    • Recruiting
    • Leeds Teaching Hospitals NHS Trust
    • Principal Investigator: Jim Zhong
  • London, United Kingdom
    • Recruiting
    • Guy's and St Thomas' NHS Foundation Trust
    • Principal Investigator: Virjen Patel
  • London, United Kingdom
    • Recruiting
    • Imperial College Healthcare NHS Foundation Trust
    • Principal Investigator: Jack Garnham
  • London, United Kingdom
    • Recruiting
    • King's College Hospital NHS FT (KCH)
    • Contact: Thomas Booth; Phone Number: 02078489568; Email: thomas.booth@kcl.ac.uk
  • London, United Kingdom
    • Recruiting
    • King's College Hospital NHS FT (PRUH)
    • Principal Investigator: Priyan Tantrige
  • London, United Kingdom
    • Recruiting
    • University College London NHS Foundation Trust
    • Principal Investigator: Indran Davagnanam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the computed tomography angiography biomarker relative to the COVID-19 RT-PCR test	Defined by sensitivity, specificity, positive and negative predictive values	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prognostic value of the computed tomography biomarker	Defined by its relationship with 30 day mortality and modified rankin scale following treatment	1 month

Collaborators and Investigators

• Sponsor: King's College Hospital NHS Trust
• Collaborators: National Institute for Health Research, United Kingdom

Study record dates

Study Major Dates

• Study Start (Actual): July 10, 2020
• Primary Completion (Anticipated): October 31, 2021
• Study Completion (Anticipated): October 31, 2021

Study Registration Dates

• First Submitted: November 20, 2020
• First Submitted That Met QC Criteria: November 20, 2020
• First Posted (Actual): November 23, 2020

Study Record Updates

• Last Update Posted (Actual): May 27, 2021
• Last Update Submitted That Met QC Criteria: May 26, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: stroke; COVID; CT; CTA
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Stroke; COVID-19; Ischemic Stroke; Hemorrhagic Stroke
• Other Study ID Numbers: COVID SALES 2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No