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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03070067
Recruitment Status : Completed
First Posted : March 3, 2017
Last Update Posted : August 18, 2017
Sponsor:
Collaborators:
Genome Canada
Genome British Columbia
Genome Alberta
Vancouver Island Health Authority
LifeLabs
Heart and Stroke Foundation of Canada
Stroke Services BC
Bruker Daltonics
British Columbia Centre for Disease Control
Information provided by (Responsible Party):
Andrew Penn, Vancouver Island Health Authority

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.


Condition or disease Intervention/treatment
TIA Other: Non-Interventional Study

Detailed Description:

Patients who fulfill all inclusion and none of the exclusion criteria after giving informed consent will be enrolled in the Validation study.

At enrollment, patients will receive a stroke nurse assessment in the Emergency Department (ED) and clinical information documented on an ACVS Assessment Form/SpecTRA Case Report Form. Patients will provide 6 mL of blood drawn into a purple-top EDTA tube that will be processed for proteomic analyses. These blood draws may or may not occur with the standard-of-care blood draw in the ED or stroke unit. Clinical orders include medical imaging (MRI +/- CT/CTA), cardiac monitoring (24hr +/- extended event monitoring). Patients will be referred by the attending ED physician to a stroke clinic for neurological consultation within 48 hours - 7 days, whereby diagnosis of (i) possible ACVS; (ii) definite ACVS or (iii) mimic will be made. At the stroke clinic a cognitive screening test will be administered either as part of usual clinical care by treating physicians, nurses, or a study coordinator. A re- assessment will be repeated at 90 days by phone. MRI will be reviewed initially for clinical interpretation at the neurological consultation for evidence of brain ischemia (DWI+) and later by neuro-radiologists for definitive diagnosis in study purposes. Final adjudication of TIA and aetiology will be done by the non-blinded principal investigators at each site based on diagnostic results plus 90-day and up to 2-year outcomes.

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Study Type : Observational
Actual Enrollment : 1150 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Spectrometry for TIA Rapid Assessment (SpecTRA) Project: Study 2-Validation of Clinical Features and Protein Biomarkers
Actual Study Start Date : April 1, 2015
Actual Primary Completion Date : March 31, 2017
Actual Study Completion Date : March 31, 2017

Group/Cohort Intervention/treatment
Mild ACVS-definite
Clinical diagnosis of ACVS, and imaging positive (either DWI+ or CT/CTA+).
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.

Mild ACVS-possible
Clinical diagnosis of ACVS, and DWI- and/or CTA-.
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.

Mimic
Clinical diagnosis of mimic and imaging negative.
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.




Primary Outcome Measures :
  1. Validation of a Protein Classifier for the Diagnosis of TIA in the Emergency Department [ Time Frame: 24 Hours ]
    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.


Secondary Outcome Measures :
  1. The Validation of a Clinical Classifier for the Diagnosis of TIA in the Emergency Department. [ Time Frame: 24 hours ]
    Calculated score for distinguishing ACVS from Mimic based on previously locked-down formula involving 50 clinical variables recorded on a standardized case report form.


Biospecimen Retention:   Samples Without DNA
Human plasma collected within 24 hours of symptom onset; MRI; Holter +\- Extended Cardiac Monitoring


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

Inclusion Criteria:

  1. Time from the neurologic event to study enrollment is within <24 hours of first symptom onset.
  2. All planned diagnostic tests for stroke evaluation must be completed, including brain imaging (MRI) within 4-7 days; and 24-hour +/- extended cardiac monitoring.
  3. 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.
  4. Age ≥18 years.
  5. Written informed consent consistent with local regulations governing research in human subjects.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070067


Locations
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Canada, Alberta
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
Canada, British Columbia
Vancouver Island Health Authority
Victoria, British Columbia, Canada, V8R 1J8
Sponsors and Collaborators
Andrew Penn
Genome Canada
Genome British Columbia
Genome Alberta
Vancouver Island Health Authority
LifeLabs
Heart and Stroke Foundation of Canada
Stroke Services BC
Bruker Daltonics
British Columbia Centre for Disease Control
Investigators
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Principal Investigator: 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
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Andrew Penn, Principal Investigator, Vancouver Island Health Authority
ClinicalTrials.gov Identifier: NCT03070067    
Other Study ID Numbers: Island Health CREB C2015-042
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: August 18, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No