The SMARTChip Stroke Study

NCT02795481 | Completed

• 1 other identifier: CI166115
• Study Type: observational
• Target: 399
• Locations: 1 country
• Sites: 1

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 best use of finite NHS specialist resources for the treatment of stroke. A simple blood test of substances (the purines) that result from cellular metabolism and are produced in excess when brain cells are starved of oxygen and glucose (as occurs during a stroke) is proposed. The sensors designed by the investigators are used to measure blood purines during a procedure in which blood flow to the brain is reduced to allow surgical interventions on the major arteries that supply the brain. Previous studies by the investigators have shown that as soon as blood flow to the brain is reduced, purines are produced within minutes and are detectable in systemic arterial blood. The current project will now compare the levels of purines in the blood of stroke patients and controls. The purines will be measured on admission to hospital and 24 hours later. The occurrence and magnitude of a stroke will be determined by an MRI scan given between 24 and 72hrs after admission. This study will establish whether purines are elevated in the blood of stroke patients on admission to hospital compared to healthy controls, and whether this correlates with the size of the stroke and damage to the brain.

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• To determine whether blood purine levels in stroke patients at admission correlate with infarct/ haemorrhage size as determined by MRI or CT scan at 24-72 hours after onset of symptoms

  24-72h after onset of symptoms

Study Arms (5)

Stroke patients

Adult stroke patients with suspected stroke will be recruited on admission to hospital. Recruitment will continue until 100 patients have received an MRI at 24h-72h post admission, up to a maximum recruitment threshold of 300 patients.

Control patients

50 adult control patients will be recruited from the non-vascular, non-oncological surgical lists at each participating site

Feeding control participants

15 healthy adult members of NHS staff will be recruited to participate in the feeding control sub-study at University Hospitals Coventry and Warwickshire NHS Trust only.

Spasticity sub-group controls

10 healthy adult members of NHS staff at University Hospitals of North Midlands, will be recruited to take part as spasticity sub-study controls

Traumatic brain injury patients

10 adult patients with an isolated traumatic brain injury at University Hospitals Coventry and Warwickshire NHS Trust and Imperial College Healthcare NHS Trust.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Stroke patients: adult patients admitted to the hospital experiencing symptoms of stroke at the time of admission Controls: adult patients scheduled to undergo non-vascular, non-oncological surgery at the participating hospital sites Feeding control and spasticity sub-study control participants: Healthy adult members of NHS staff Traumatic brain injury sub-study: Adult patients with an isolated traumatic brain injury.

You may qualify if:

• 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.

You may not qualify if:

• 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
• Aged 18 years and over
• Scheduled for surgery
• Available for follow-up
• 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
• Aged 18 years and over

Sponsors & Collaborators

• University Hospitals Coventry and Warwickshire NHS Trust: lead

Study Sites (1)

University Hospitals Coventry & Warwickshire NHS Trust

Coventry, CV2 2DX, United Kingdom

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Christopher Imray, PhD

  University Hospitals Coventry and Warwickshire NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 6, 2016
• First Posted: June 10, 2016
• Study Start: July 13, 2016
• Primary Completion: May 20, 2022
• Study Completion: May 20, 2022
• Last Updated: July 12, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)