Reactivation of Varicella Zoster Virus and Risk of Vascular Disease

Withdrawn

• Conditions: Varicella Zoster; Stroke; Transient Ischaemic Attack; Acute Myocardial Infarction

• Registration Number: NCT02559596
• Lead Sponsor: University College, London

Brief 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.

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 Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-09-23
• Study First Submitted QC: 2015-09-23
• Study First Posted: 2015-09-24
• Status Verified: 2019-01
• Primary Completion: 2019-01
• Study Completion: 2019-01
• Last Update Submitted: 2019-01-03
• Last Update Posted: 2019-01-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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