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Translational Immunodiagnostics in Stroke (TrImS)

ConditionsAcute 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
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-100
SponsorThe University of Hong Kong

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

Clear onset of acute symptoms >24 hours.

Trial population

Suspected stroke patients presenting to emergency department within 24 hours of symptom onset.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Biomarker blood draw and saliva collection

    Diagnostic test

    Three peripheral 10mL blood sample (if available) Three 1 - 3mL salivary samples (if available)

Treatment groups

650 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: Haemorrhagic Stroke [N=100]1 intervention
Group B: Acute Ischaemic Stroke [N=300]1 intervention
Group C: Stroke of uncertain origin [N=45]1 intervention
Group D: Transient Ischemic Attack (TIA) [N=75]1 intervention
Group E: Stroke Mimics [N=30]1 intervention
Group F: Control Subjects [N=100]1 intervention

Trial outcomes

Primary outcomes

1

Differentiation of stroke from non-stroke in patients with suspected stroke

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.

Time frame
Up to 24 hours

Secondary outcomes

1

Differentiation of Transient Ischaemic Attack (TIA) from Transient non-neurological events (TNE) in patients with suspected acute stroke

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. TNE is migraine, seizure or syncope.

Time frame
Up to 24 hours
2

Differentiation of acute ischaemic stroke(AIS) from haemorrhagic stroke(HS) in patients with suspected acute stroke before and after imaging

AIS is defined as an acute infarct on CT/MRI. HS is defined as an acute haemorrhage on CT/MRI.

Time frame
Up to 24 hours
3

Differentiation of AIS-LVAD from AIS-SVD from AIS-CE in patients with suspected acute stroke

AIS-LVAD is defined as an acute infarct on CT/MRI due to large vessel artery disease. The cause is a local obstruction (usually thrombus) in a large vessel with atherosclerosis (typically the common or internal carotid arteries, vertebral artery and Circle of Willis) which is usually treated with thrombectomy. AIS-SVD is defined as an acute infarct on CT/MRI within 10 days of symptom onset due to small vessel disease. The cause is a local obstruction in smaller arteries (typically branches of the Circle of Willis, middle cerebral artery, vertebral artery and basilar arteries) for which thrombectomy is not indicated. AIS-CE is defined as an acute infarct on CT/MRI due to an embolism from elsewhere in the body e.g. the heart or an extracranial large vessel.

Time frame
Up to 24 hours
4

Differentiation of stroke of known origin (AIS/HS) from cryptogenic stroke in patients with suspected acute stroke

Stroke of known origin, including acute ischemic stroke (AIS) of known origin and haemorrhagic stroke (HS). AIS is defined as an acute infarct on CT/MRI. HS is defined as an acute haemorrhage on CT/MRI. The American College of Cardiology state, 'There is no universally accepted definition for cryptogenic stroke . . .Cryptogenic stroke is defined by TOAST as stroke not caused by large artery atherosclerosis, cardioembolism, and small vessel occlusion; cryptogenic stroke is also defined as a stroke of undetermined etiology due to two or more causes being identified, negative evaluation, or incomplete evaluation. . . cryptogenic stroke is a diagnosis of exclusion - it is an ischemic stroke with no identifiable etiology'.

Time frame
Up to 24 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The University of Hong Kong

Lead sponsor

Source ClinicalTrials.gov
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