Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

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.

Condition or disease Intervention/treatment
TIA Other: Non-Interventional Study

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 560 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spectrometry for TIA Rapid Assessment (SpecTRA) Project: Study 1 Cohort 1A and 1B-Verification of Protein Biomarkers
Actual Study Start Date : December 1, 2013
Actual Primary Completion Date : June 30, 2015
Actual Study Completion Date : December 31, 2016

Group/Cohort Intervention/treatment
Mild ACVS-definite
Clinical diagnosis of ACVS, and imaging positive (either DWI+ or CT/CTA+).
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.

Mild ACVS-possible
Clinical diagnosis of ACVS, and DWI- and/or CTA-
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.

Mimic
Clinical diagnosis of mimic and imaging negative.
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.




Primary Outcome Measures :
  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 Outcome Measures :
  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).


Biospecimen Retention:   Samples Without DNA
Human plasma collected within 24 hours of symptom onset; MRI; Holter +/- Extended Cardiac Monitoring


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050099


Locations
Layout table for location information
Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia
Vancouver Island Health Authority
Victoria, British Columbia, Canada, V8R 1J8
Sponsors and Collaborators
Andrew Penn
Genome Canada
Genome British Columbia
Genome Alberta
Heart and Stroke Foundation of Canada
Stroke Services BC
Bruker Daltonics
LifeLabs
Investigators
Layout table for investigator information
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
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Andrew Penn, Principal Investigator, Vancouver Island Health Authority
ClinicalTrials.gov Identifier: NCT03050099    
Other Study ID Numbers: Island Health CREB 2013-023
First Posted: February 10, 2017    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No