Status:
COMPLETED
The SMARTChip Stroke Study
Lead Sponsor:
University Hospitals Coventry and Warwickshire NHS Trust
Conditions:
Stroke
Eligibility:
All Genders
18+ years
Brief Summary
Stroke is one of the leading causes of death and disability in the UK and currently costs the country £7bn per year. There is an overwhelming need to accurately and rapidly triage patients to allow be...
Detailed Description
Stroke patients will be prospectively recruited to the trial on admission to A\&E. The patient will undergo normal clinical assessment and treatment for stroke. As soon after admission as possible, a ...
Eligibility Criteria
Inclusion
- Main study
- Stroke patients:
- Inclusion criteria:
- Aged 18 years or over
- Admitted to hospital with suspected stroke, diagnosed by a suitably qualified doctor or nurse using an appropriate clinical assessment (e.g. FAST, NIHSS, WHO criteria)
- Patient has ongoing symptoms of stroke at the time of enrolment in to the study.
- Exclusion criteria:
- Onset of stroke symptoms \>4.5 hours prior to admission or time of onset of symptoms is not known
- Patient has undergone thrombolysis during current admission (N.B. patients can be enrolled before planned thrombolysis, but not after)
- Patient's stroke symptoms have resolved completely prior to enrolment in the study
- The patient, or their consultee if the patient is incapacitated, is unwilling to provide written informed consent
- Healthy controls
- Inclusion criteria:
- Aged 18 years and over
- Scheduled for surgery
- Available for follow-up
- Exclusion criteria:
- History of, or evidence of current, cerebrovascular disease, including stroke, transient ischaemic attack, subarachnoid haemorrhage and vascular dementia
- History of cardiovascular disease, including myocardial infarction, angina or peripheral vascular disease
- History of, or current, gout
- Currently receiving chemotherapy
- History of diabetes
- Unwilling or unable to provide written informed consent
- Feeding Controls sub-study Inclusion criteria
- Aged 18 years and over
- Member of NHS staff
- Willing to eat the study meal provided (sandwich with a meat based filling)
- Exclusion criteria
- Current acute health problems requiring medical review, investigation, or treatment
- History of, or evidence of current, cerebrovascular disease, including stroke, transient ischaemic attack, subarachnoid haemorrhage and vascular dementia
- History of cardiovascular disease, including myocardial infarction, angina or peripheral vascular disease
- History of, or current, gout
- Currently receiving chemotherapy
- History of diabetes
- Unwilling or unable to provide written informed consent
- Spasticity sub-study
- Stroke patients Inclusion criteria - Patients with suspected stroke, who have been enrolled on to the main study at UHNM
- Exclusion criteria
- \- Unwilling or unable to provide written informed consent to the spasticity sub-study
- Controls Inclusion criteria
- Aged 18 years and over
- Member of NHS staff
- Willing to complete follow-up visits
- Exclusion criteria
- Current acute health problems requiring medical review, investigation, or treatment
- History of, or evidence of current, cerebrovascular disease, including stroke, transient ischaemic attack, subarachnoid haemorrhage and vascular dementia
- History of cardiovascular disease, including myocardial infarction, angina or peripheral vascular disease
- History of gout
- Currently receiving chemotherapy
- History of diabetes
- Unwilling or unable to provide written informed consent
- Traumatic brain injury sub-study
- Inclusion criteria:
- Aged 18 years or over
- Admitted to hospital with Traumatic brain injury, diagnosed by a suitably qualified doctor with CT scan supporting evidence of a bleed and/or clot.
- Exclusion criteria:
- The patient, or their consultee if the patient is incapacitated, is unwilling to provide written informed consent
- History of Cancer
Exclusion
Key Trial Info
Start Date :
July 13 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 20 2022
Estimated Enrollment :
399 Patients enrolled
Trial Details
Trial ID
NCT02795481
Start Date
July 13 2016
End Date
May 20 2022
Last Update
July 12 2022
Active Locations (1)
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1
University Hospitals Coventry & Warwickshire NHS Trust
Coventry, United Kingdom, CV2 2DX