NCT05300997 Translational Immunodiagnostics in Stroke (TrImS)
| NCT ID | NCT05300997 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Hong Kong |
| Condition | Acute Ischemic Stroke |
| Study Type | OBSERVATIONAL |
| Enrollment | 650 participants |
| Start Date | 2022-05-01 |
| Primary Completion | 2027-08-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 650 participants in total. It began in 2022-05-01 with a primary completion date of 2027-08-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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.
Contact & Investigator
Timothy H Rainer, MD
PRINCIPAL INVESTIGATOR
The University of Hong Kong
Frequently Asked Questions
Who can join the NCT05300997 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Acute Ischemic Stroke. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05300997 currently recruiting?
Yes, NCT05300997 is actively recruiting participants. Contact the research team at thrainer@hku.hk for enrollment information.
Where is the NCT05300997 trial being conducted?
This trial is being conducted at Hong Kong, China.
Who is sponsoring the NCT05300997 clinical trial?
NCT05300997 is sponsored by The University of Hong Kong. The principal investigator is Timothy H Rainer, MD at The University of Hong Kong. The trial plans to enroll 650 participants.
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