Reactivation of Varicella Zoster Virus and Risk of Vascular Disease

January 3, 2019 updated by: University College, London

Reactivation of Varicella Zoster Virus and Risk of Vascular Disease in the Health Survey for England: a Nested Case Control Study

The purpose of this study is to investigate whether there is an association between stroke or heart attack and reactivation of varicella zoster virus, measured by antibody levels, using linked data from the Health Survey for England and secondary care.

Study Overview

Status

Withdrawn

Conditions

Detailed Description

This study will use a case control design to investigate whether adult participants in the Health Survey for England between 2009 and 2013 who were admitted to hospital with either a stroke or heart attack had higher preceding levels of varicella zoster virus antibodies measured in stored serum samples compared to matched controls with no history of heart attack or stroke, controlling for a range of potential demographic, lifestyle and clinical confounders.

This study is funded by the University College London Hospitals Biomedical Research Centre Fast Track grant scheme and has received ethics approval (ref 15/NW/0456).

Study Type

Observational

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The study population will be drawn from adults who have already participated in the Health Survey for England between 2009 and 2013 and who have a stored serum sample available for analysis. No new participants will be recruited.

Description

Inclusion Criteria:

  • Previous participant in the HSE between 2009 and 2013 with stored serum available.
  • Either a record of stroke or TIA or MI in linked HES data between 01/01/2009 and 31/12/2013 or selected as a matched control for those with a record of stroke/ TIA/MI in HES data.
  • Male or female, aged 16 years or above.

Exclusion Criteria:

  • HSE participant with no stored serum sample

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cases
Adults (aged 16+) with stored serum samples collected for the Health Survey for England (HSE) between 2009 and 2013, who have a record of hospitalisation for stroke, transient ischaemic attack or myocardial infarction occurring after their participation in the HSE.
Controls
Adults (aged 16+) with stored serum samples collected for the Health Survey for England (HSE) between 2009 and 2013, who do not have a record of hospitalisation for stroke, transient ischaemic attack or myocardial infarction and are matched to cases on age, gender and year of participation in the HSE.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Odds ratio for the effect of high serum antibody titre on stroke or other vascular outcomes
Time Frame: Outcome assessed within 5 years of serum sample
Outcome assessed within 5 years of serum sample

Secondary Outcome Measures

Outcome Measure
Time Frame
Prevalence of age- and sex-specific serum VZV antibody titres as a marker for virus reactivation
Time Frame: Assessed at baseline recruitment to the HSE
Assessed at baseline recruitment to the HSE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Investigators

  • Principal Investigator: Charlotte Warren-Gash, MRCP PhD, UCL

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2015

Primary Completion (Actual)

January 1, 2019

Study Completion (Actual)

January 1, 2019

Study Registration Dates

First Submitted

September 23, 2015

First Submitted That Met QC Criteria

September 23, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Actual)

January 4, 2019

Last Update Submitted That Met QC Criteria

January 3, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15/0311
  • F192 (Other Grant/Funding Number: University College London Hospitals BRC)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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