NCT04640428

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 10, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 23, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2021

Completed
Last Updated

May 27, 2021

Status Verified

May 1, 2021

Enrollment Period

1.3 years

First QC Date

November 20, 2020

Last Update Submit

May 26, 2021

Conditions

Keywords

COVIDstrokeCTCTA

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Prognostic value of the computed tomography biomarker

    1 month

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Royal United Hospitals Bath NHS Foundation Trust

Bath, United Kingdom

RECRUITING

North Bristol NHS Trust

Bristol, United Kingdom

RECRUITING

University Hospitals Bristol NHS Foundation Trust

Bristol, United Kingdom

RECRUITING

Frimley Health NHS Foundation Trust

Camberley, United Kingdom

RECRUITING

Cardiff and Vale University Health Board

Cardiff, United Kingdom

RECRUITING

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, United Kingdom

RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

RECRUITING

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

RECRUITING

Imperial College Healthcare NHS Foundation Trust

London, United Kingdom

RECRUITING

King's College Hospital NHS FT (KCH)

London, United Kingdom

RECRUITING

King's College Hospital NHS FT (PRUH)

London, United Kingdom

RECRUITING

University College London NHS Foundation Trust

London, United Kingdom

RECRUITING

MeSH Terms

Conditions

COVID-19StrokeIschemic StrokeHemorrhagic Stroke

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2020

First Posted

November 23, 2020

Study Start

July 10, 2020

Primary Completion

October 31, 2021

Study Completion

October 31, 2021

Last Updated

May 27, 2021

Record last verified: 2021-05

Locations