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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-01

Study Completion Date

2017-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03050099

TIA

COMPLETED

BRAIN (Biomarker Rapid Assessment of Ischemic iNjury)

NCT00206908

Stroke Stroke Mimic(Conditions Presenting With Stroke-like Conditions)

COMPLETED

Mild and Rapidly Improving Stroke Study

NCT02072681

Ischemic Stroke

COMPLETED

Biomarkers of Acute Stroke in Clinic

NCT03897478

Ischemic Stroke Ischemia Atrial Fibrillation +14 more

UNKNOWN

Personalized Antiplatelet Secondary Stroke PRevenTion

NCT03979781

Ischemic Stroke TIA

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

TIA

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Mild ACVS-definite

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

Non-Interventional Study

Intervention Type 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-possible

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

Non-Interventional Study

Intervention Type 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.

Mimic

Clinical diagnosis of mimic and imaging negative.

Non-Interventional Study

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No