Reactivation of Varicella Zoster Virus and Risk of Vascular Disease

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02559596
• Other study ID #: 15/0311
• Secondary ID: F192
• Status: Withdrawn
• Start date: June 2015
• Est. completion date: January 2019

Study information

• Verified date: January 2019
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Chickenpox
• Herpes Zoster
• Infarction
• Ischemic Attack, Transient
• Myocardial Infarction
• Stroke
• Transient Ischaemic Attack
• Varicella Zoster
• Vascular Diseases

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University College, London

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Prevalence of age- and sex-specific serum VZV antibody titres as a marker for virus reactivation		Assessed at baseline recruitment to the HSE