Reactivation of Varicella Zoster Virus and Risk of Vascular Disease

NCT02559596 | Withdrawn

• 2 other identifiers: 15/0311F192
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Varicella Zoster; Stroke; Transient Ischaemic Attack; Acute Myocardial Infarction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Prevalence of age- and sex-specific serum VZV antibody titres as a marker for virus reactivation

  Assessed at baseline recruitment to the HSE

Study Arms (2)

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.

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• HSE participant with no stored serum sample

Sponsors & Collaborators

• University College, London: lead

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Study Officials

• Charlotte Warren-Gash, MRCP PhD

  UCL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 23, 2015
• First Posted: September 24, 2015
• Study Start: June 1, 2015
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: January 4, 2019

Record last verified: 2019-01