TIANCT03050099
SpecTRA; An Observational Study of the Verification of Protein Biomarkers in Transient Ischemic Attack.
An observational study of TIA, run by Andrew Penn at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- TIA
- What is being tested?
- Non-Interventional Study
- How many people
- 560 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Dec 2013to 31 Dec 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Foothills Medical Centre
Calgary, Alberta, T2N 2T9
Vancouver Island Health Authority
Victoria, British Columbia, V8R 1J8
About this study
Official title: Spectrometry for TIA Rapid Assessment (SpecTRA) Project: Study 1 Cohort 1A and 1B-Verification of Protein Biomarkers
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.
Read the 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.
- Conditions
- TIA
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
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 group | Role | What they receive |
|---|---|---|
| Mild ACVS-definite | Clinical diagnosis of ACVS, and imaging positive (either DWI+ or CT/CTA+). Receives: Other: Non-Interventional Study | |
| Mild ACVS-possible | Clinical diagnosis of ACVS, and DWI- and/or CTA- Receives: Other: Non-Interventional Study | |
| Mimic | Clinical diagnosis of mimic and imaging negative. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Development of a Protein Classifier for the Diagnosis of TIA in the Emergency Department.
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.
Measured: 24 Hours
Secondary outcomes (1)
The Development of a Clinical Classifier for the Diagnosis of TIA in the Emergency Department.
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).
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2017
- Study start1 Dec 2013
- Primary completion30 Jun 2015
- Study completion31 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TIAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Penn
- Sponsor type
- University, hospital or other
- Collaborators
- Genome Canada, Genome British Columbia, Genome Alberta, Heart and Stroke Foundation of Canada, Stroke Services BC, Bruker Daltonics, LifeLabs
- Responsible party
- Sponsor-investigator, Andrew Penn, Vancouver Island Health Authority
- Investigators
- Andrew M Penn, M.D, Principal investigator, Vancouver Island Health AuthorityShelagh Coutts, M.D., Principal investigator, Alberta Health servicesChristoph Borchers, P.hD, Principal investigator, UVic- Genome BC Proteomics Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03050099
- Sponsor's protocol ID
- Island Health CREB 2013-023
- Status last verified
- Feb 2017
- First submitted
- 8 Feb 2017
- Last updated
- 3 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 26484650Penn 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.
PubMed 31653207
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spectrometry for TIA Rapid Assessment (SpecTRA) Project: Study 1 Cohort 1A and 1B-Verification of Protein Biomarkers
- ClinicalTrials.gov ID
- NCT03050099
- Acronym / sponsor ID
- Island Health CREB 2013-023
- Conditions
- TIA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 560 participants (actual)
- Lead sponsor
- Andrew PennUniversity, hospital or other
- Collaborators
- Genome Canada, Genome British Columbia, Genome Alberta, Heart and Stroke Foundation of Canada, Stroke Services BC, Bruker Daltonics, LifeLabs
- Study start
- 1 Dec 2013 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 10 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Mild ACVS-definite | – | Other: Non-Interventional StudyClinical diagnosis of ACVS, and imaging positive (either DWI+ or CT/CTA+). |
| Mild ACVS-possible | – | Other: Non-Interventional StudyClinical diagnosis of ACVS, and DWI- and/or CTA- |
| Mimic | – | Other: Non-Interventional StudyClinical diagnosis of mimic and imaging negative. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Interventional StudyThis is a non-interventional study. However, several blood samples will be taken which would not be taken as part of standard of care. | Other | Mild ACVS-definite, Mild ACVS-possible, Mimic |
Primary outcome
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.
1 secondary outcome
The Development of a Clinical Classifier for the Diagnosis of TIA in the Emergency Department.
Time frame: 24 Hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2017.
- Results publication: PubMed 26484650Penn 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.
- Derived from this study: PubMed 31653207Penn 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew M Penn, M.D principal investigator
Vancouver Island Health Authority
Shelagh Coutts, M.D. principal investigator
Alberta Health services
Christoph Borchers, P.hD principal investigator
UVic- Genome BC Proteomics Centre
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of TIA, run by Andrew Penn at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Development of a Protein Classifier for the Diagnosis of TIA in the Emergency Department. (time frame: 24 Hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03050099, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2017; AzTrials last refreshed its copy on 8 Nov 2026.