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Completed

NCT Number: NCT03050099

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

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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Key information

Conditions

TIA

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Foothills Medical Centre, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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
  • 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

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

Treatment and study plan

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.

Primary outcomes

  1. The Development of a Protein Classifier for the Diagnosis of TIA in the Emergency Department.

    Time frame: 24 Hours

    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.

Secondary outcomes

  1. The Development of a Clinical Classifier for the Diagnosis of TIA in the Emergency Department.

    Time frame: 24 Hours

    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).

Sponsors and collaborators

Lead sponsor

Andrew Penn

Other

Collaborators

  • Bruker Daltonics
  • Genome Alberta
  • Genome British Columbia
  • Genome Canada
  • Heart and Stroke Foundation of Canada
  • LifeLabs
  • Stroke Services BC

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Feb 10, 2017
Registry last updated
Mar 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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