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

NCT03050099 | Completed DMC

• 1 other identifier: Island Health CREB 2013-023
• Study Type: observational
• Target: 560
• Locations: 1 country
• Sites: 2

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.

Conditions

TIA

Outcome Measures

Primary Outcomes (1)

• 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.

  24 Hours

Secondary Outcomes (1)

• The Development of a Clinical Classifier for the Diagnosis of TIA in the Emergency Department.

  24 Hours

Study Arms (3)

Mild ACVS-definite

Clinical diagnosis of ACVS, and imaging positive (either DWI+ or CT/CTA+).

Other: Non-Interventional Study

Mild ACVS-possible

Clinical diagnosis of ACVS, and DWI- and/or CTA-

Other: Non-Interventional Study

Mimic

Clinical diagnosis of mimic and imaging negative.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

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-definite; Mild ACVS-possible; Mimic

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Andrew Penn: lead
• Genome Canada: collaborator
• Genome British Columbia: collaborator
• Genome Alberta: collaborator
• Heart and Stroke Foundation of Canada: collaborator
• Stroke Services BC: collaborator
• Bruker Daltonics: collaborator
• LifeLabs: collaborator

Study Sites (2)

Foothills Medical Centre

Calgary, Alberta, T2N 2T9, Canada

Location

Vancouver Island Health Authority

Victoria, British Columbia, V8R 1J8, Canada

Location

Related Publications (2)

• 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.

  PMID: 26484650 RESULT

• 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.

  PMID: 31653207 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Human plasma collected within 24 hours of symptom onset; MRI; Holter +/- Extended Cardiac Monitoring

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 8, 2017
• First Posted: February 10, 2017
• Study Start: December 1, 2013
• Primary Completion: June 30, 2015
• Study Completion: December 31, 2016
• Last Updated: March 3, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)