Stroke, AcuteTIMESNCT03521882
Timed Interval Measurement of Eotaxin in Stroke Study
An observational study of Stroke, Acute, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Stroke is caused by sudden changes in blood flow in the brain. This can be fatal or can result in permanent disability. A fast diagnosis is essential to initiate effective interventions and optimize benefits to patients. There are other diseases that can look like a stroke and these are called "stroke mimics". Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Acute
- How many people
- 80 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 22 May 2017to 30 May 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals presenting to hospital with focal neurological symptoms suggestive of stroke aged over 18 years.
Who may be able to join
- Presenting with focal neurological symptoms suggestive of stroke
- Aged over 18 years
Who cannot join
- Presenting later than 12 hours after symptom onset
- Under 18 years of age
- History of cardiovascular disease (Healthy Controls)
- History of neurological disease (Healthy Controls)
- History of stroke mimics (Healthy Controls)
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Royal Devon & Exeter NHS Foundation Trust
Exeter, Devon, EX2 5DW
About this study
Stroke is caused by sudden changes in blood flow in the brain. This can be fatal or can result in permanent disability. A fast diagnosis is essential to initiate effective interventions and optimize benefits to patients. There are other diseases that can look like a stroke and these are called "stroke mimics". The quicker that stroke mimics can be ruled out the faster a stroke can be diagnosed and treatment can be given. The investigators may be able to use chemicals in the blood to rapidly confirm that a person has had a stroke. One such chemical is called eotaxin. Eotaxin has been found to be changed in sufferers of a stroke but not in those with stroke mimics. However, more research is needed to confirm the usefulness of eotaxin. This feasibility study aims to provide the foundations to allow a large scale trial of this test. The study aims to recruit participants that have had a stroke or a stroke mimic from the Acute Stroke Unit and Stroke clinic at the Royal Devon and Exeter Hospital. Up to 6 blood samples will be taken from each participant at different times over one week. Eotaxin will be measured in these samples and in participant's leftover samples taken for clinical care. This is needed because the investigators know that the amount of eotaxin changes in the blood after a stroke but we do not know how quickly this change happens and for how long the change occurs. The study will also allow the investigators to understand how many participants will be needed for a large scale trial and the challenges that may be faced in recruiting participants.
- Conditions
- Stroke, Acute
- Medical subject headings
- Stroke
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 |
|---|---|---|
| Stroke Symptom Participants | Not described | |
| Healthy Controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome
Plasma Eotaxin Concentration
Measured: 0 to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2018
- Study start22 May 2017
- Primary completion30 May 2019
- Study completion30 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, AcuteStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Devon and Exeter NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Salim Elyas, PhD MRCP, Principal investigator, Royal Devon and Exeter NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03521882
- Sponsor's protocol ID
- Protocol v5 15/05/17
- Acronym
- TIMES
- Status last verified
- Nov 2020
- First submitted
- 30 Apr 2018
- Last updated
- 6 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timed Interval Measurement of Eotaxin in Stroke Study
- ClinicalTrials.gov ID
- NCT03521882
- Acronym / sponsor ID
- TIMES / Protocol v5 15/05/17
- Conditions
- Stroke, Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Royal Devon and Exeter NHS Foundation TrustUniversity, hospital or other
- Study start
- 22 May 2017 (actual)
- Primary completion
- 30 May 2019 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 11 May 2018 (actual)
- 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.
Stroke is caused by sudden changes in blood flow in the brain. This can be fatal or can result in permanent disability. A fast diagnosis is essential to initiate effective interventions and optimize benefits to patients. There are other diseases that can look like a stroke and these are called "stroke mimics". The quicker that stroke mimics can be ruled out the faster a stroke can be diagnosed and treatment can be given. The investigators may be able to use chemicals in the blood to rapidly confirm that a person has had a stroke. One such chemical is called eotaxin. Eotaxin has been found to be changed in sufferers of a stroke but not in those with stroke mimics. However, more research is needed to confirm the usefulness of eotaxin. This feasibility study aims to provide the foundations to allow a large scale trial of this test. The study aims to recruit participants that have had a stroke or a stroke mimic from the Acute Stroke Unit and Stroke clinic at the Royal Devon and Exeter Hospital. Up to 6 blood samples will be taken from each participant at different times over one week. Eotaxin will be measured in these samples and in participant's leftover samples taken for clinical care. This is needed because the investigators know that the amount of eotaxin changes in the blood after a stroke but we do not know how quickly this change happens and for how long the change occurs. The study will also allow the investigators to understand how many participants will be needed for a large scale trial and the challenges that may be faced in recruiting participants.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke Symptom Participants | – | – |
| Healthy Controls | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals presenting to hospital with focal neurological symptoms suggestive of stroke aged over 18 years.
Key inclusion criteria (2 listed)
- Presenting with focal neurological symptoms suggestive of stroke
- Aged over 18 years
Key exclusion criteria (5 listed)
- Presenting later than 12 hours after symptom onset
- Under 18 years of age
- History of cardiovascular disease (Healthy Controls)
- History of neurological disease (Healthy Controls)
- History of stroke mimics (Healthy Controls)
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
Primary Outcome
Time frame: 0 to 7 days
Plasma Eotaxin Concentration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2020.
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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.
Salim Elyas, PhD MRCP principal investigator
Royal Devon and Exeter NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke, Acute, run by Royal Devon and Exeter NHS Foundation Trust at 1 site in United Kingdom.
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 6 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Primary Outcome (time frame: 0 to 7 days). 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 6 Nov 2020.