Varicella ZosterNCT02559596
Reactivation of Varicella Zoster Virus and Risk of Vascular Disease
An observational study of Varicella Zoster and Stroke, run by University College, London.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Varicella Zoster, Stroke, Transient Ischaemic Attack
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- HSE participant with no stored serum sample
About this study
Official title: Reactivation of Varicella Zoster Virus and Risk of Vascular Disease in the Health Survey for England: a Nested Case Control Study
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.
Read the 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).
- Medical subject headings
- Stroke, Ischemic Attack, Transient
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Odds ratio for the effect of high serum antibody titre on stroke or other vascular outcomes
Measured: 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
Measured: Assessed at baseline recruitment to the HSE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startJun 2015
- Primary completionJan 2019
- Study completionJan 2019
Why it stopped: Linked data not available for research within requisite time period
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicella ZosterStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Charlotte Warren-Gash, MRCP PhD, Principal investigator, UCL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559596
- Sponsor's protocol ID
- 15/0311
- Other IDs
- F192
- Status last verified
- Jan 2019
- First submitted
- 23 Sep 2015
- Last updated
- 4 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reactivation of Varicella Zoster Virus and Risk of Vascular Disease in the Health Survey for England: a Nested Case Control Study
- ClinicalTrials.gov ID
- NCT02559596
- Acronym / sponsor ID
- 15/0311
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Linked data not available for research within requisite time period
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- HSE participant with no stored serum sample
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte Warren-Gash, MRCP PhD principal investigator
UCL
Questions about this trial
What is this clinical trial studying?
An observational study of Varicella Zoster and Stroke, run by University College, London.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 4 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2019.