NCT02984280

Brief Summary

This study will investigate whether there is a population-level association between circulating respiratory viruses and NHS hospital admissions for acute vascular events using data from national infection surveillance and Hospital Episode Statistics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
787,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 4, 2017

Status Verified

November 1, 2016

Enrollment Period

6 months

First QC Date

December 2, 2016

Last Update Submit

May 3, 2017

Conditions

Influenza, HumanRespiratory Syncytial Virus InfectionsParainfluenzaRhinovirusAdenovirusHuman Metapneumovirus PneumoniaCardiovascular Diseases

Outcome Measures

Primary Outcomes (2)

  • Acute myocardial infarction

    ICD-10 coded

    01/01/2004 to 31/12/2014

  • Stroke

    ICD-10 coded

    01/01/2004 to 31/12/2014

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult population of England who have received NHS care during the study period.

You may qualify if:

  • Any individual with a record of an eligible outcome (ICD-10 coded hospitalisation for myocardial infarction or stroke) within the study period aged 45+ years
  • Any individual with a record of an eligible exposure (laboratory-confirmed respiratory virus) within the study period at any age

You may not qualify if:

  • Outcome events occurring in people aged \<45 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London (UCL)

London, NW1 2DA, United Kingdom

Location

Related Publications (1)

  • Blackburn R, Zhao H, Pebody R, Hayward A, Warren-Gash C. Laboratory-Confirmed Respiratory Infections as Predictors of Hospital Admission for Myocardial Infarction and Stroke: Time-Series Analysis of English Data for 2004-2015. Clin Infect Dis. 2018 Jun 18;67(1):8-17. doi: 10.1093/cid/cix1144.

    PMID: 29324996DERIVED

MeSH Terms

Conditions

Influenza, HumanRespiratory Syncytial Virus InfectionsParamyxoviridae InfectionsAdenoviridae InfectionsCardiovascular Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract DiseasesPneumovirus InfectionsMononegavirales InfectionsDNA Virus Infections

Study Officials

  • Charlotte MJ Warren-Gash, MRCP PhD

    UCL

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 2, 2016

First Posted

December 6, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2017

Study Completion

March 1, 2017

Last Updated

May 4, 2017

Record last verified: 2016-11

Locations

GB(1)