Stroke, IschemicPREDICT-EVNCT05645081
Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke
An observational study of Stroke, Ischemic and Transient Ischemic Attack, run by Cwm Taf University Health Board (NHS) at 1 site in United Kingdom.
Trial summary
Annually 100,000 strokes occur, placing stroke as the largest cause of disability in the UK. 90% of strokes are preventable, leading to national focus on programmes including "The National Stroke Programme" to act on preventing, treating, and improving post-stroke care. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stroke, Ischemic, Transient Ischemic Attack, Coagulation Disorder
- How many people
- 360 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2021to 1 Sep 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The sample will be selected from patients attending TIA clinic appointments, following primary care referral. Participants may also be identified from accident and emergency or following admission into hospital.
The inclusion criteria for phase 1 (initial patient recruitment) will be:
- Patients with or without diagnosis of TIA made by a physician working in stroke medicine, sufficiently so to start post-TIA care or so that no further investigation is thought necessary to confirm or refute the diagnosis.
- TIA confirmed patient has been prescribed antiplatelet drugs or anticoagulants.
- Patients must be aged > 18 years.
- Patients are taking an ordinary diet by mouth.
The inclusion criteria for phase 2 (patient representing with stroke) will be:
- Radiological evidence, on CT and/or MR imaging of the brain of cerebral infarction, with or without secondary haemorrhage.
- The underlying mechanism of cerebral infarction is embolic from a cardiac source (e.g. atrial fibrillation), atherothromboembolic (from aorta or other large vessels in the neck) or in-situ thrombosis. No further investigations are thought necessary to confirm or refute the diagnosis.
- No further investigations are thought necessary to confirm or refute the diagnosis.
- Patients must be aged >18 years.
- Patients must not be pregnant or breast feeding.
- Patients are taking an ordinary diet by mouth. Exclusion Criteria
The Exclusion criteria for phase 1 (initial patient recruitment) will be:
- Inability to give consent.
- Inability to feed by mouth.
- Short life expectancy.
- Pregnancy or breastfeeding.
- Symptoms are readily explained by medical problems not involving focal cerebral ischaemia.
The Exclusion criteria for phase 2 (patient representing with stroke) will be:
- Patients who have not previously given consent for follow up blood sampling.
- Patients who are unable to feed by mouth.
- Patients in whom life expectancy is short.
- Patient is pregnant or breast feeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Prince Charles Hospital
Merthyr Tydfil, CF479DT
Rhian Beynon, LLM, 01443 443443 ext. 75627, Rhian.Beynon@wales.nhs.uk
About this study
Official title: PREDICT-EV; the Association of Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke
Annually 100,000 strokes occur, placing stroke as the largest cause of disability in the UK. 90% of strokes are preventable, leading to national focus on programmes including "The National Stroke Programme" to act on preventing, treating, and improving post-stroke care. Importantly, over 25% of ischaemic stroke sufferers have previously had a Transient Ischaemic Attack (TIA), which presents the biggest concern for TIA patients. There are no measures which reliably identify TIA patients most likely to suffer a stroke. Novel biomarkers for predicting stroke are key to addressing this problem. The PREDICT-EV study aims to screen 300 TIA patients and follow them over 12-months. The investigators will determine if a novel biomarker we've identified to increase thrombotic risk (endothelial derived extracellular vesicles) and the resulting increased prothrombin time is associated with patients at highest risk of stroke.
- Keywords
- Stroke Risk, Transient Ischemic Attack, Extracellular Vesicles, Pro-Thrombotic Risk
- Medical subject headings
- Ischemic Stroke, Ischemic Attack, Transient, Hemostatic Disorders
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 |
|---|---|---|
| Healthy Control | A group of participants with no previous symptoms or diagnosis of TIA or stroke. | |
| Non-TIA Control | A group of participants who were referred to TIA clinic with symptoms of a TIA, however, were subsequently confirmed as not suffering with a TIA. | |
| TIA, non-stroke | A group of participants who were confirmed as suffering a TIA by a stroke clinician following admission to hospital, admission to Accident and Emergency or after being referred to TIA clinic. These participants did not suffer a stroke within 12 months of TIA diagnosis. | |
| TIA, stroke | A group of participants who were confirmed as suffering a TIA by a stroke clinician following admission to hospital, admission to Accident and Emergency or after being referred to TIA clinic. These participants went on to suffer a stroke within 12 months of TIA diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the endothelial derived extracellular vesicle population
Measured: 3 years
Change in patient Prothrombin time
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start1 Oct 2021
- Primary completion1 Sep 2026 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stroke, IschemicStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cwm Taf University Health Board (NHS)
- Sponsor type
- Other government
- Collaborators
- Cardiff Metropolitan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05645081
- Sponsor's protocol ID
- CT/1245/281530/19/20
- Acronym
- PREDICT-EV
- Status last verified
- Feb 2024
- First submitted
- 1 Dec 2022
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREDICT-EV; the Association of Extracellular Vesicles and Dysregulated Coagulation in the Prediction of Stroke
- ClinicalTrials.gov ID
- NCT05645081
- Acronym / sponsor ID
- PREDICT-EV / CT/1245/281530/19/20
- Keywords
- Stroke Risk, Transient Ischemic Attack, Extracellular Vesicles, Pro-Thrombotic Risk
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Cwm Taf University Health Board (NHS)Other government
- Collaborators
- Cardiff Metropolitan University
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 9 Dec 2022 (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.
Annually 100,000 strokes occur, placing stroke as the largest cause of disability in the UK. 90% of strokes are preventable, leading to national focus on programmes including "The National Stroke Programme" to act on preventing, treating, and improving post-stroke care. Importantly, over 25% of ischaemic stroke sufferers have previously had a Transient Ischaemic Attack (TIA), which presents the biggest concern for TIA patients. There are no measures which reliably identify TIA patients most likely to suffer a stroke. Novel biomarkers for predicting stroke are key to addressing this problem. The PREDICT-EV study aims to screen 300 TIA patients and follow them over 12-months. The investigators will determine if a novel biomarker we've identified to increase thrombotic risk (endothelial derived extracellular vesicles) and the resulting increased prothrombin time is associated with patients at highest risk of stroke.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Healthy Control | – | –A group of participants with no previous symptoms or diagnosis of TIA or stroke. |
| Non-TIA Control | – | –A group of participants who were referred to TIA clinic with symptoms of a TIA, however, were subsequently confirmed as not suffering with a TIA. |
| TIA, non-stroke | – | –A group of participants who were confirmed as suffering a TIA by a stroke clinician following admission to hospital, admission to Accident and Emergency or after being referred to TIA clinic. These participants did not suffer a stroke within 12 months of TIA diagnosis. |
| TIA, stroke | – | –A group of participants who were confirmed as suffering a TIA by a stroke clinician following admission to hospital, admission to Accident and Emergency or after being referred to TIA clinic. These participants went on to suffer a stroke within 12 months of TIA diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The sample will be selected from patients attending TIA clinic appointments, following primary care referral. Participants may also be identified from accident and emergency or following admission into hospital.
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
Change in the endothelial derived extracellular vesicle population
Time frame: 3 years
Change in patient Prothrombin time
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Individual participant dataSharing planned: No
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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.
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, Ischemic and Transient Ischemic Attack, run by Cwm Taf University Health Board (NHS) 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?
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: looking for participants now, as of the sponsor's last update on 20 Aug 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jessica Williams, PhD (02920417077, jwilliams3@cardiffmet.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the endothelial derived extracellular vesicle population (time frame: 3 years). The study lists 2 primary outcomes in all. 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 20 Aug 2024.