Translational Immunodiagnostics in Stroke (TrImS) (NCT05300997) | Clinical Trial Compass
RecruitingNot Applicable
Translational Immunodiagnostics in Stroke (TrImS)
China650 participantsStarted 2022-05-01
Plain-language 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
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Differentiation of stroke from non-stroke in patients with suspected stroke