Reactivation of Varicella Zoster Virus and Risk of Vascular Disease

Sponsor

University College, London (Other)

Overall Status

Withdrawn

CT.gov ID

NCT02559596

Collaborator

(none)

Enrollment

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Varicella Zoster Stroke Transient Ischaemic Attack Acute Myocardial Infarction

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 Design

Study Type:

Observational

Actual Enrollment :

0 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Study Start Date :

Jun 1, 2015

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jan 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.