Overview

This trial is active, not recruiting.

Conditions varicella zoster, stroke, transient ischaemic attack, acute myocardial infarction
Sponsor University College, London
Start date June 2015
End date December 2016
Trial size 2000 participants
Trial identifier NCT02559596, 15/0311, F192

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective retrospective
Arm
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.
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.

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 16 years old.

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

Additional Information

Official title Reactivation of Varicella Zoster Virus and Risk of Vascular Disease in the Health Survey for England: a Nested Case Control Study
Principal investigator Charlotte Warren-Gash, MRCP PhD
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).
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University College, London.