Identifying biomarkers for early detection of acute stroke
Translational Immunodiagnostics in Suspected Stroke (TrImS): A Two-centre, Pragmatic, Prospective, Observational Study
This study is trying to find specific markers in blood and saliva that can help doctors quickly and accurately diagnose strokes in adults who come to the emergency room with symptoms.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 650 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | The University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05300997 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on adult patients presenting to emergency departments with suspected acute stroke within 24 hours of symptom onset. The research aims to identify specific biomarkers in blood and saliva that can aid in the early detection, diagnosis, and prognosis of various types of strokes. By analyzing these biomarkers, the study seeks to develop and validate models that can improve the accuracy and speed of stroke diagnosis. The ultimate goal is to enhance patient outcomes through timely and precise medical intervention.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who present with suspected acute stroke symptoms within 24 hours of onset.
Not a fit: Patients who do not exhibit symptoms of acute stroke or are outside the 24-hour window from symptom onset may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to faster and more accurate diagnosis of acute strokes, potentially improving treatment outcomes for patients.
How similar studies have performed: While there have been studies exploring biomarkers in stroke detection, this approach focusing on both blood and saliva biomarkers for early diagnosis is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Hong Kong
- Hong Kong University — Hong Kong, China (Recruiting)
Study contacts
- Principal investigator: Timothy H Rainer, MD — The University of Hong Kong
- Study coordinator: Timothy H Rainer, MD
- Email: thrainer@hku.hk
- Phone: +852 39176846
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.