Translational Immunodiagnostics in Stroke (TrImS)
Recruiting · NCT05300997 · Observational (researchers observe without assigning treatment) · Lead sponsor: The University of Hong Kong
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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
Who can take part
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.
Where it is running
1 location listed.
- Hong Kong University - Hong Kong, China