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

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ClinicalTrials.gov Identifier: NCT03050099
Recruitment Status : Completed
First Posted : February 10, 2017
Last Update Posted : March 3, 2017
Sponsor:
Collaborators:
Genome Canada
Genome British Columbia
Genome Alberta
Heart and Stroke Foundation of Canada
Stroke Services BC
Bruker Daltonics
LifeLabs
Information provided by (Responsible Party):
Andrew Penn, Vancouver Island Health Authority

Tracking Information
First Submitted Date February 8, 2017
First Posted Date February 10, 2017
Last Update Posted Date March 3, 2017
Actual Study Start Date December 1, 2013
Actual Primary Completion Date June 30, 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 8, 2017)
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: February 28, 2017)
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).
Original Secondary Outcome Measures
 (submitted: February 8, 2017)
The Development of a Clinical Classifier for the Diagnosis of TIA in the Emergency Department. [ Time Frame: up to 7 days ]
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).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SpecTRA; An Observational Study of the Verification of Protein Biomarkers in Transient Ischemic Attack.
Official Title Spectrometry for TIA Rapid Assessment (SpecTRA) Project: Study 1 Cohort 1A and 1B-Verification of Protein Biomarkers
Brief 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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Human plasma collected within 24 hours of symptom onset; MRI; Holter +/- Extended Cardiac Monitoring
Sampling Method Non-Probability Sample
Study Population 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.
Condition TIA
Intervention 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.
Study Groups/Cohorts
  • Mild ACVS-definite
    Clinical diagnosis of ACVS, and imaging positive (either DWI+ or CT/CTA+).
    Intervention: Other: Non-Interventional Study
  • Mild ACVS-possible
    Clinical diagnosis of ACVS, and DWI- and/or CTA-
    Intervention: Other: Non-Interventional Study
  • Mimic
    Clinical diagnosis of mimic and imaging negative.
    Intervention: Other: Non-Interventional Study
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 8, 2017)
560
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2016
Actual Primary Completion Date June 30, 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Canada
Removed Location Countries  
 
Administrative Information
NCT Number NCT03050099
Other Study ID Numbers Island Health CREB 2013-023
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Andrew Penn, Vancouver Island Health Authority
Study Sponsor Andrew Penn
Collaborators
  • Genome Canada
  • Genome British Columbia
  • Genome Alberta
  • Heart and Stroke Foundation of Canada
  • Stroke Services BC
  • Bruker Daltonics
  • LifeLabs
Investigators
Principal Investigator: 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
PRS Account Vancouver Island Health Authority
Verification Date February 2017