SpecTRA; A Study of the Validation of Protein Biomarkers in Transient Ischemic Attack

NCT03070067 | Completed DMC

• 1 other identifier: Island Health CREB C2015-042
• Study Type: observational
• Target: 1,150
• Locations: 1 country
• Sites: 2

Brief Summary

A clinical decision support rule/tool for classification of TIA/mimic that will enable rapid detection of ACVS in hyper-acute settings is being developed. Also under development is a multi-protein test using mass spectrometry (MS). This test will provide TIA results within an hour or two for a fraction of the price of neuroimaging. With guidance provided by this test at their disposal, physicians can inform patients whether they can go home safely or whether they need further testing. The right patients will receive the right treatment, reduce unwarranted imaging risks and costs, and reduce the burden of stroke. The Heart and Stroke Foundation will work to ensure that physicians, allied healthcare providers, the public and other stakeholders are aware of the outcomes and clinical impacts of this project. Further, work is being done to establish the mechanisms to develop a strong phenotype for TIA that includes medical imaging (MRI), cardiac monitoring, cognitive assessments, and surveillance of health outcomes for extended periods of time.

Conditions

TIA

Outcome Measures

Primary Outcomes (1)

• Validation of a Protein Classifier for the Diagnosis of TIA in the Emergency Department

  Calculated score for distinguishing ACVS from Mimic based on previously locked-down formula involving 16 proteins measured using multiple reaction monitoring in blood samples taken within 24 hours from onset of symptoms.

  24 Hours

Secondary Outcomes (1)

• The Validation 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
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population includes individuals presenting to the hospital ED or stroke clinic with symptoms suggesting mild ACVS who would be referred to the outpatient stroke clinic. Patients will be recruited primarily from emergency department settings or hospital-based stroke units.

You may qualify if:

• Time from the neurologic event to study enrollment is within \<24 hours of first symptom onset.
• All planned diagnostic tests for stroke evaluation must be completed, including brain imaging (MRI) within 4-7 days; and 24-hour +/- extended cardiac monitoring.
• Be able to provide blood samples collected either under standard-of-care presentation in the ED or hospital-based stroke unit, or by a study-specific personnel outside of standard-of-care collections.
• Age ≥18 years.
• Written informed consent consistent with local regulations governing research in human subjects.

You may not qualify if:

• Stroke severity exceeding 4 on the National Institutes of Health Stroke Severity scale (NIHSS \<4).
• Contraindications to brain imaging.
• Non-English speaking, unless translator present.
• Isolated monocular blindness.

Sponsors & Collaborators

• Andrew Penn: lead
• Genome Canada: collaborator
• Genome British Columbia: collaborator
• Genome Alberta: collaborator
• Vancouver Island Health Authority: collaborator
• LifeLabs: collaborator
• Heart and Stroke Foundation of Canada: collaborator
• Stroke Services BC: collaborator
• Bruker Daltonics: collaborator
• British Columbia Centre for Disease Control: 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 (1)

• 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 28, 2017
• First Posted: March 3, 2017
• Study Start: April 1, 2015
• Primary Completion: March 31, 2017
• Study Completion: March 31, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)