SpecTRA; An Observational Study of the Verification of Protein Biomarkers in Transient Ischemic Attack.
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| ClinicalTrials.gov Identifier: NCT03050099 |
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Recruitment Status :
Completed
First Posted : February 10, 2017
Last Update Posted : March 3, 2017
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Sponsor:
Andrew Penn
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 | ||||||||||
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| 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 |
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.
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| Original Primary Outcome Measures | Same as current | |||||||||
| Change History | ||||||||||
| Current Secondary Outcome Measures |
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).
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| Original Secondary Outcome Measures |
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).
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| 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. |
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| Study Type | Observational | |||||||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
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| 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
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| 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.
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| Study Groups/Cohorts |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | ||||||||||
| Recruitment Status | Completed | |||||||||
| Actual Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 | |||||||||
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| Administrative Information | ||||||||||
| NCT Number | NCT03050099 | |||||||||
| Other Study ID Numbers | Island Health CREB 2013-023 | |||||||||
| Has Data Monitoring Committee | Yes | |||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Andrew Penn, Vancouver Island Health Authority | |||||||||
| Study Sponsor | Andrew Penn | |||||||||
| Collaborators |
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| Investigators |
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| PRS Account | Vancouver Island Health Authority | |||||||||
| Verification Date | February 2017 | |||||||||