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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

560 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-01

Study Completion Date

2016-12-31

Brief Summary

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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.

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Detailed Description

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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

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TIA

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Mild ACVS-definite

Clinical diagnosis of ACVS, and imaging positive (either DWI+ or CT/CTA+).

Non-Interventional Study

Intervention Type 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.

Mild ACVS-possible

Clinical diagnosis of ACVS, and DWI- and/or CTA-

Non-Interventional Study

Intervention Type 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.

Mimic

Clinical diagnosis of mimic and imaging negative.

Non-Interventional Study

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age 19 and older
2. Suspected TIA (as per \<4 NIHSS; or ED physician referral to stroke clinic;
3. English speaking or translator available
4. Competent to provide consent and report symptoms
5. Provides at least one blood sample for the study within 24 hours after symptom onset

* If three blood samples, then the patient is included in the Verification study 1 Cohort A.
* If one blood sample, then patient is included in the Verification study 1 Cohort B.

Exclusion Criteria

1. Stroke requiring admission to hospital based on only clinical observations (including CT scan) made before the MRI.
2. Unable to have MRI/CT
3. Subject unable to provide consent.
4. Isolated monocular blindness.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No