Stroke Circulatory System
Conditions
Interventions
Patients with suspected stroke who meet the inclusion criteria will be recruited to undergo additional serum, urine and saliva sampling but otherwise will receive standard care and investigations as p
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Study group: Patients who have suffered an acute brain injury from confirmed stroke resulting in presentation to University Hospitals Birmingham Control group: Patients with a 'stroke mimic' (an alternative diagnosis presenting as stroke); non-head trauma patients
Exclusion criteria
Exclusion criteria: Study group: patients under 18 years of age; patients with devastating injury who are unlikely to survive >24 hours Control group: patients under 18 years of age; patients with a recent head injury or known neurological condition; patients with a devastating injury who are unlikely to survive >24 hours
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sensitivity, specificity, negative predictive value, positive predictive value, area under receiver operating curve (ROC) for individual components and a combined diagnostic panel of serum, urine and saliva biomarkers (as outlined in the Interventions section) to differentiate between stroke and stroke mimics at the time of first contact with a healthcare professional up to 24 hours post-suspected stroke 2. Functional status measured using the modified Rankin Scale at 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Functional outcome measured using the EuroQol health-related quality of life (EQ-5D-5L) and the Quality of Life after Brain Injury (QOLIBRI patient-reported outcomes) scales at 6 and 12 months 2. Mental health status measured using the Patient Health Questionnaire-9 (PHQ-9) for depression and Generalised Anxiety Disorder Assessment (GAD-7) for anxiety at 6 and 12 months 3. Exploratory analysis of the correlation between serum, salivary and urine biomarkers measured using magnetic resonance spectroscopy (MRS) at 3, 6 and 12 months | — |
Countries
England, United Kingdom
Contacts
Public ContactAntonio Belli
Outcome results
None listed