Specific Respiratory Infections as Triggers of Acute Medi... | NCT02984280

Studies
Specific Respiratory Infections as Triggers of Acute Medical Events

NCT02984280

Sponsor

University College, London

Status

Completed

Last Update Posted

May 4, 2017Actual

Enrollment

787,000Actual

Phase

Not provided

Conditions

Influenza, Human
Respiratory Syncytial Virus Infections
Parainfluenza
Rhinovirus
Adenovirus
Human Metapneumovirus Pneumonia
Cardiovascular Diseases

Interventions

Not provided

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016

Primary Completion Date

Mar 2017Actual

Completion Date

Mar 2017Actual

First Submitted Date

Dec 2, 2016

First Submission Date that Met QC Criteria

Dec 2, 2016

First Posted Date

Dec 6, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 3, 2017

Last Update Posted Date

May 4, 2017Actual

Name	Class
Public Health England	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

We will conduct a time series study correlating anonymised population level data on all samples from NHS laboratories testing positive for six common respiratory viruses with admissions to NHS hospitals in England for a range of cardiac and vascular outcomes over the time period 01/01/2004 to 31/12/2014. This will involve generating Poisson regression models controlling for factors such as seasonal and long-term trends, environmental temperature and humidity.

This study is funded by an Academy of Medical Sciences Starter Grant for Clinical Lecturers.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

787,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acute myocardial infarction	ICD-10 coded	01/01/2004 to 31/12/2014
Stroke	ICD-10 coded	01/01/2004 to 31/12/2014

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Outcome events occurring in people aged <45 years

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Charlotte MJ Warren-Gash, MRCP PhD	UCL	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University College London (UCL)		London		NW1 2DA	United Kingdom

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29324996	Derived	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.

ID	Term
D007251	Influenza, Human
D018357	Respiratory Syncytial Virus Infections
D018184	Paramyxoviridae Infections
D000257	Adenoviridae Infections
D002318	Cardiovascular Diseases

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections