- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
- Foothills Medical Centre
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British Columbia
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Victoria, British Columbia, Canada, V8R 1J8
- Vancouver Island Health Authority
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Mild ACVS-definite
Clinical diagnosis of ACVS, and imaging positive (either DWI+ or CT/CTA+).
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This is a non-interventional study.
However, several blood samples will be taken which would not be taken as part of standard of care.
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Mimic
Clinical diagnosis of mimic and imaging negative.
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This is a non-interventional study.
However, several blood samples will be taken which would not be taken as part of standard of care.
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Mild ACVS-possible
Clinical diagnosis of ACVS, and DWI- and/or CTA-
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This is a non-interventional study.
However, several blood samples will be taken which would not be taken as part of standard of care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Development of a Protein Classifier for the Diagnosis of TIA in the Emergency Department.
Time Frame: 24 Hours
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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.
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24 Hours
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The Development of a Clinical Classifier for the Diagnosis of TIA in the Emergency Department.
Time Frame: 24 Hours
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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).
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24 Hours
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Andrew M Penn, M.D, Vancouver Island Health Authority
- Principal Investigator: Christoph Borchers, P.hD, UVic- Genome BC Proteomics Centre
Publications and helpful links
General Publications
- Penn AM, Lu L, Chambers AG, Balshaw RF, Morrison JL, Votova K, Wood E, Smith DS, Lesperance M, del Zoppo GJ, Borchers CH; SpecTRA Study Group. Exploring phlebotomy technique as a pre-analytical factor in proteomic analyses by mass spectrometry. Genome. 2015 Dec;58(12):569-76. doi: 10.1139/gen-2015-0036. Epub 2015 Jul 10.
- Penn AM, Croteau NS, Votova K, Sedgwick C, Balshaw RF, Coutts SB, Penn M, Blackwood K, Bibok MB, Saly V, Hegedus J, Yu AYX, Zerna C, Klourfeld E, Lesperance ML. Systolic blood pressure as a predictor of transient ischemic attack/minor stroke in emergency department patients under age 80: a prospective cohort study. BMC Neurol. 2019 Oct 25;19(1):251. doi: 10.1186/s12883-019-1466-4.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- Island Health CREB 2013-023
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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