SpecTRA; A Study of the Validation of Protein Biomarkers in Transient Ischemic Attack
SpecTRA; A Study of the Validation of Protein Biomarkers in Transient Ischemic Attack
A clinical decision support rule/tool for classification of TIA/mimic that will enable rapid
 detection of ACVS in hyper-acute settings is being developed. Also under development is a
 multi-protein test using mass spectrometry (MS). This test will provide TIA results within an
 hour or two for a fraction of the price of neuroimaging. With guidance provided by this test
 at their disposal, physicians can inform patients whether they can go home safely or whether
 they need further testing. The right patients will receive the right treatment, reduce
 unwarranted imaging risks and costs, and reduce the burden of stroke. The Heart and Stroke
 Foundation will work to ensure that physicians, allied healthcare providers, the public and
 other stakeholders are aware of the outcomes and clinical impacts of this project.

 Further, work is being done to establish the mechanisms to develop a strong phenotype for TIA
 that includes medical imaging (MRI), cardiac monitoring, cognitive assessments, and
 surveillance of health outcomes for extended periods of time.
Patients who fulfill all inclusion and none of the exclusion criteria after giving informed
 consent will be enrolled in the Validation study.

 At enrollment, patients will receive a stroke nurse assessment in the Emergency Department
 (ED) and clinical information documented on an ACVS Assessment Form/SpecTRA Case Report Form.
 Patients will provide 6 mL of blood drawn into a purple-top EDTA tube that will be processed
 for proteomic analyses. These blood draws may or may not occur with the standard-of-care
 blood draw in the ED or stroke unit. Clinical orders include medical imaging (MRI +/-
 CT/CTA), cardiac monitoring (24hr +/- extended event monitoring). Patients will be referred
 by the attending ED physician to a stroke clinic for neurological consultation within 48
 hours - 7 days, whereby diagnosis of (i) possible ACVS; (ii) definite ACVS or (iii) mimic
 will be made. At the stroke clinic a cognitive screening test will be administered either as
 part of usual clinical care by treating physicians, nurses, or a study coordinator. A re-
 assessment will be repeated at 90 days by phone. MRI will be reviewed initially for clinical
 interpretation at the neurological consultation for evidence of brain ischemia (DWI+) and
 later by neuro-radiologists for definitive diagnosis in study purposes. Final adjudication of
 TIA and aetiology will be done by the non-blinded principal investigators at each site based
 on diagnostic results plus 90-day and up to 2-year outcomes.
Inclusion Criteria:

 1. Time from the neurologic event to study enrollment is within <24 hours of first
 symptom onset.

 2. All planned diagnostic tests for stroke evaluation must be completed, including brain
 imaging (MRI) within 4-7 days; and 24-hour +/- extended cardiac monitoring.

 3. Be able to provide blood samples collected either under standard-of-care presentation
 in the ED or hospital-based stroke unit, or by a study-specific personnel outside of
 standard-of-care collections.

 4. Age ≥18 years.

 5. Written informed consent consistent with local regulations governing research in human
 subjects.

 Exclusion Criteria:

 1. Stroke severity exceeding 4 on the National Institutes of Health Stroke Severity scale
 (NIHSS <4).

 2. Contraindications to brain imaging.

 3. Non-English speaking, unless translator present.

 4. Isolated monocular blindness.