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| Name | Class |
|---|---|
| Genome Canada | OTHER |
| Genome British Columbia | INDUSTRY |
| Genome Alberta | OTHER |
| Heart and Stroke Foundation of Canada |
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A multi-protein test using mass spectrometry (MS) for multiplexed protein quantitation is being developed. This test and the accompanying decision-aid software will provide Transient Ischemic Attack (TIA) results rapidly for a fraction of the price of neuroimaging. With guidance provided by this test, Emergency Department (ED) physicians can manage medical imaging questions such as the use of Computed Tomography Angiography (CTA) prior to ED discharge and appropriate (timely) referral to stroke clinics for consultation and follow-up care. The right patients will receive the right treatment, reduce unwarranted imaging risks and costs, and reduce the burden of stroke.
This study represents an initial Verification study, in which Mass Spectrometry will be used to quantify a large number of blood proteins previously implicated in ACVS and mimic conditions in patients who are consented and enrolled in the Emergency Department within 24 hrs of symptom onset. 560 patients will be enrolled, and grouped into two cohorts (Cohort 1A: 220; and Cohort 1B: 350).
In Cohort 1A, each consented participant provides three blood samples: on arrival, 4-6 hours later, then ~24 hours after that, but no later than 32 hours from symptom onset. In cohort 1b, each patient provides only a single blood sample up to 24 hours from symptom onset.
A positive diffusion-weighted imaging (DWI) signal on Magnetic Resonance Imaging (MRI) or definite ischemia on Computed tomography (CT) or vascular occlusion on CTA will be used as proof of ischemia to classify the clinical phenotype into three groups (see below). A neurologist will adjudicate all cases according to a study defined adjudication protocol.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild ACVS-definite | Clinical diagnosis of ACVS, and imaging positive (either DWI+ or CT/CTA+). |
| |
| Mild ACVS-possible | Clinical diagnosis of ACVS, and DWI- and/or CTA- |
| |
| Mimic | Clinical diagnosis of mimic and imaging negative. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | This is a non-interventional study. However, several blood samples will be taken which would not be taken as part of standard of care. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The Development of a Protein Classifier for the Diagnosis of TIA in the Emergency Department. | 141 proteins measured using multiple reaction monitoring mass spectrometry. Proteins were selected due to previous implication in stroke, TIA, migraine, other conditions that can be confused with ACVS, and other cardiovascular disturbances. | 24 Hours |
| Measure | Description | Time Frame |
|---|---|---|
| The Development of a Clinical Classifier for the Diagnosis of TIA in the Emergency Department. | Clinical score calculated from standard clinical variables using our previously published formula. This score was developed to distinguish ACVS patients (who have had a recent ACVS) from Mimic (patients with symptoms that mimic those of ACVS). | 24 Hours |
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Inclusion Criteria:
Age 19 and older
Suspected TIA (as per <4 NIHSS; or ED physician referral to stroke clinic;
English speaking or translator available
Competent to provide consent and report symptoms
Provides at least one blood sample for the study within 24 hours after symptom onset
Exclusion Criteria:
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All patients presenting to the hospital Emergency Department with symptoms suggesting mild ACVS and who are referred to the stroke service or TIA rapid access clinic by the emergency room physician.
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| Name | Affiliation | Role |
|---|---|---|
| Andrew M Penn, M.D | Vancouver Island Health Authority | Principal Investigator |
| Shelagh Coutts, M.D. | Alberta Health services | Principal Investigator |
| Christoph Borchers, P.hD | UVic- Genome BC Proteomics Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Foothills Medical Centre | Calgary | Alberta | T2N 2T9 | Canada | ||
| Vancouver Island Health Authority |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26484650 | Result | Penn AM, Lu L, Chambers AG, Balshaw RF, Morrison JL, Votova K, Wood E, Smith DS, Lesperance M, del Zoppo GJ, Borchers CH; SpecTRA Study Group. Exploring phlebotomy technique as a pre-analytical factor in proteomic analyses by mass spectrometry. Genome. 2015 Dec;58(12):569-76. doi: 10.1139/gen-2015-0036. Epub 2015 Jul 10. | |
| 31653207 |
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| OTHER |
| Stroke Services BC | UNKNOWN |
| Bruker Daltonics | INDUSTRY |
| LifeLabs | UNKNOWN |
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Human plasma collected within 24 hours of symptom onset; MRI; Holter +/- Extended Cardiac Monitoring
| Victoria |
| British Columbia |
| V8R 1J8 |
| Canada |
| Penn AM, Croteau NS, Votova K, Sedgwick C, Balshaw RF, Coutts SB, Penn M, Blackwood K, Bibok MB, Saly V, Hegedus J, Yu AYX, Zerna C, Klourfeld E, Lesperance ML. Systolic blood pressure as a predictor of transient ischemic attack/minor stroke in emergency department patients under age 80: a prospective cohort study. BMC Neurol. 2019 Oct 25;19(1):251. doi: 10.1186/s12883-019-1466-4. |