NCT03050099

SpecTRA; An Observational Study of the Verification of Protein Biomarkers in Transient Ischemic Attack.

Spectrometry for TIA Rapid Assessment (SpecTRA) Project: Study 1 Cohort 1A and 1B-Verification of Protein Biomarkers

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 560 (actual)
• Sponsor: Andrew Penn · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• TIA

Interventions

Type	Name	Description
OTHER	Non-Interventional Study	This is a non-interventional study. However, several blood samples will be taken which would not be taken as part of standard of care.

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-06-30
• Completion: 2016-12-31
• First posted: 2017-02-10
• Last updated: 2017-03-03

Locations

2 sites across 1 country: Canada