Clinical trial NCT03050099: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: TIA
Lead sponsor: Vancouver Island Health Authority
Sponsor class: OTHER
Collaborators: name: Genome Canada
name: Genome British Columbia
name: Genome Alberta
name: Heart and Stroke Foundation of Canada
name: Stroke Services BC
name: Bruker Daltonics
name: LifeLabs
First posted: 2017-02-10
Enrollment: 560
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: The Development of a Protein Classifier for the Diagnosis of TIA in the Emergency Department.
timeFrame: 24 Hours
Secondary outcomes:
measure: The Development of a Clinical Classifier for the Diagnosis of TIA in the Emergency Department.
timeFrame: 24 Hours
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Foothills Medical Centre
state: Alberta
city: Victoria
country: Canada
facility: Vancouver Island Health Authority
state: British Columbia
Study officials:
affiliation: Vancouver Island Health Authority
name: Andrew M Penn, M.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Alberta Health services
name: Shelagh Coutts, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: UVic- Genome BC Proteomics Centre
name: Christoph Borchers, P.hD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.