Acute Ischemic StrokeHaemorrhagic StrokeTransient Ischemic AttacksCardioembolic StrokeLarge-Artery Atherosclerosis (Embolus/Thrombosis)Small Vessel DiseaseStroke of Other Determined EtiologyStroke of Undetermined EtiologyAtrial FibrillationStroke of Anterior Cerebral ArteryStroke of Middle Cerebral ArteryStroke of Basilar Artery
Investigational drug(s) / intervention(s)
Biomarker blood draw and saliva collection
Biomarker blood draw and saliva collection: Three peripheral 10mL blood sample (if available) Three 1 - 3mL salivary samples (if available)
Study summary
In adult patients presenting to emergency departments within 24 hours of symptom onset with suspected acute stroke, we aim:
1. to identify early brain- and pathology-specific circulating, whole blood, plasma and serum panorOmic biomarkers that enable early acute stroke detection, diagnosis, dynamics, differentiation, monitoring, prediction and prognosis.
2. to identify early brain- and pathology-specific, panorOmic biomarkers in saliva that enable early acute stroke detection, diagnosis, dynamics, differentiation, monitoring, prediction and prognosis.
3. to derive biomarker platforms of models for early acute stroke detection, diagnosis, dynamics, differentiation, monitoring, prediction and prognosis
4. to validate these models in independent and external datasets
Eligibility
Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
Accepted
Inclusion Criteria:
* Patients eligible for enrolment include:
* Adults ≥18 years of age.
* Suspected acute stroke. Defined as either FAST-positive, or LAPSS-positive or ROSIER\>0
* Within 24 hours of symptom onset.
* Informed consent.
* Control subjects will be drawn from two groups:
* Non-neurologic patients who are matched with TIA and stroke cases (AIS, HS) for age, race, gender and smoking plus one or more of the following vascular risk factors: diabetes, hypertension, atrial fibrillation, hyperlipidaemia.
* Relatives or accompanying friends.
* Note that we will include and collect samples from the following cases if they present as suspected stroke and are recruited \<24 hours from symptom onset.
* Any central nervous system infection, i.e. meningitis or encephalitis in the past 30 days
* Any form of head trauma, stroke or intracranial haemorrhage in the past 30 days
* Known primary or metastatic cancer involving the brain
* Active cancer is defined as a diagnosis of cancer, within 6 months before enrollment, any treatment for cancer within the previous 6 months, or recurrent or metastatic cancer.
* Autoimmune diseases: such as lupus, rheumatoid arthritis, Crohn's disease, ulcerative colitis
* Active infectious diseases (e.g. HIV/AIDS, hepatitis C)
* Major surgery within three months prior to the index event
Exclusion Criteria:
* Clear onset of acute symptoms \>24 hours.
Primary outcome measure(s)
Differentiation of stroke from non-stroke in patients with suspected stroke — Up to 24 hours Stroke is defined as either a) the presence of intracerebral haemorrhage with imaging; or b) intracerebral ischaemia with imaging; or c) clinical features of stroke in the absence of positive imaging persisting after 24 hours (cryptogenic stroke). Cryptogenic stroke is defined according to TOAST as stroke not caused by large artery atherosclerosis, cardioembolism, small vessel occlusion and stroke of other aetiology.
Non-stroke includes TIA and stroke mimics. TIA is defined as the resolution of stroke-like symptoms within 24 hours of onset and the absence of acute cerebral abnormalities on CT/MRI. Stroke mimics are defined as diseases caused by neurologic symptoms that resemble a stroke. For example, seizure, complex migraines, demyelinating disease, meningitis, glucose level variations and metabolic disorders (hypoglycemia), tumors, non-cerebrovascular diseases such as epilepsy, and dementia.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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