RecruitingNCT05300997

Translational Immunodiagnostics in Stroke (TrImS)

Translational Immunodiagnostics in Suspected Stroke (TrImS): A Two-centre, Pragmatic, Prospective, Observational Study

Sponsor

The University of Hong Kong

Enrollment

650 participants

Start Date

May 1, 2022

Study Type

OBSERVATIONAL

Conditions

Atrial Fibrillation Acute Ischemic Stroke Cardioembolic Stroke Haemorrhagic Stroke Transient Ischemic Attacks Large-Artery Atherosclerosis (Embolus/Thrombosis)Small Vessel Disease Stroke of Other Determined Etiology Stroke of Undetermined Etiology Stroke of Anterior Cerebral Artery Stroke of Middle Cerebral Artery Stroke of Basilar Artery

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

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria16

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