Atrial Fibrillation Clinical Trial
— TrImSOfficial title:
Translational Immunodiagnostics in Suspected Stroke (TrImS): A Two-centre, Pragmatic, Prospective, Observational Study
NCT number | NCT05300997 |
Other study ID # | TrImS-RAINER-2021 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 1, 2022 |
Est. completion date | May 30, 2025 |
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
Status | Recruiting |
Enrollment | 650 |
Est. completion date | May 30, 2025 |
Est. primary completion date | May 30, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Hong Kong University | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
China,
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Differentiation of stroke from non-stroke in patients with suspected stroke | Stroke is defined as either a) the presence of intracerebral haemorrhage with imaging; or b) intracerebral ischaemia with imaging; or c) clinical features of stroke in the absence of positive imaging persisting after 24 hours (cryptogenic stroke). Cryptogenic stroke is defined according to TOAST as stroke not caused by large artery atherosclerosis, cardioembolism, small vessel occlusion and stroke of other aetiology.
Non-stroke includes TIA and stroke mimics. TIA is defined as the resolution of stroke-like symptoms within 24 hours of onset and the absence of acute cerebral abnormalities on CT/MRI. Stroke mimics are defined as diseases caused by neurologic symptoms that resemble a stroke. For example, seizure, complex migraines, demyelinating disease, meningitis, glucose level variations and metabolic disorders (hypoglycemia), tumors, non-cerebrovascular diseases such as epilepsy, and dementia. |
Up to 24 hours | |
Secondary | Differentiation of Transient Ischaemic Attack (TIA) from Transient non-neurological events (TNE) in patients with suspected acute stroke | TIA is defined as the resolution of stroke-like symptoms within 24 hours of onset and the absence of acute cerebral abnormalities on CT/MRI. TNE is migraine, seizure or syncope. | Up to 24 hours | |
Secondary | Differentiation of acute ischaemic stroke(AIS) from haemorrhagic stroke(HS) in patients with suspected acute stroke before and after imaging | AIS is defined as an acute infarct on CT/MRI. HS is defined as an acute haemorrhage on CT/MRI. | Up to 24 hours | |
Secondary | Differentiation of AIS-LVAD from AIS-SVD from AIS-CE in patients with suspected acute stroke | AIS-LVAD is defined as an acute infarct on CT/MRI due to large vessel artery disease. The cause is a local obstruction (usually thrombus) in a large vessel with atherosclerosis (typically the common or internal carotid arteries, vertebral artery and Circle of Willis) which is usually treated with thrombectomy.
AIS-SVD is defined as an acute infarct on CT/MRI within 10 days of symptom onset due to small vessel disease. The cause is a local obstruction in smaller arteries (typically branches of the Circle of Willis, middle cerebral artery, vertebral artery and basilar arteries) for which thrombectomy is not indicated. AIS-CE is defined as an acute infarct on CT/MRI due to an embolism from elsewhere in the body e.g. the heart or an extracranial large vessel. |
Up to 24 hours | |
Secondary | Differentiation of stroke of known origin (AIS/HS) from cryptogenic stroke in patients with suspected acute stroke | Stroke of known origin, including acute ischemic stroke (AIS) of known origin and haemorrhagic stroke (HS). AIS is defined as an acute infarct on CT/MRI. HS is defined as an acute haemorrhage on CT/MRI.
The American College of Cardiology state, 'There is no universally accepted definition for cryptogenic stroke . . .Cryptogenic stroke is defined by TOAST as stroke not caused by large artery atherosclerosis, cardioembolism, and small vessel occlusion; cryptogenic stroke is also defined as a stroke of undetermined etiology due to two or more causes being identified, negative evaluation, or incomplete evaluation. . . cryptogenic stroke is a diagnosis of exclusion - it is an ischemic stroke with no identifiable etiology'. |
Up to 24 hours | |
Secondary | Differentiation of early stroke onset (<4.5 hours) from late stroke onset (>4.5 hours) | Early AIS is defined as CT/MRI evidence of ischaemia within 4.5 hours of symptom onset. | Up to 24 hours | |
Secondary | Mortality | Mortality is defined as all-cause, post-stroke. | Up to 30-days | |
Secondary | Post-stroke Rankin score | Post-stroke Rankin score is defined as a six-point scale where 1 is normal and 6 is death. | Up to 90-days | |
Secondary | Development of point-of-care biomarker platforms for classifying patients presenting with suspected acute stroke | An accurate biomarker platform is defined as a combination of biomarkers that achieve a high area under the curve (AUC >0.9) and either a high sensitivity (>95%) or a high specificity (>95%) for the differentiation of all above outcomes (outcome 1 to outcome 8). | Up to 90-days | |
Secondary | Post-stroke QALY score | QALY is defined as a Quality Adjusted Life Year. One QALY is one year of life lived in perfect health. One year of life lived in less than perfect health is <1 QALY. | Up to 1 year |
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