Validation of Sensitivity and Specificity of a Multi-Omic Precision Diagnostic for Acute Stroke Evaluation

NCT02753257 | Unknown DMC

• 1 other identifier: ValtariBio-5-01
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

Brief Summary

Valtari Bio has early proof of concept clinical data of a multi-omic peripheral blood biomarker profile that can be used to determine stroke from no stroke in the emergency setting. The objective of this observational cohort clinical study is to determine the clinical utility of this multi-omic biomarker profile. Primary Study Aims:

1. 1.The diagnostic tests characteristics of a multi-omic biomarker diagnostic for stroke (ischemic stroke, transient ischemic attack (TIA) and hemorrhagic stroke) versus no stroke (stroke mimic).
2. 2.The ability of a multi-omic biomarker profile to differentiate ischemic stroke from hemorrhagic stroke and TIA.

Conditions

Stroke

Keywords

stroke; stroke mimic

Outcome Measures

Primary Outcomes (1)

• Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI

  within the first 24 hours of emergency evaluation

Interventions

Non-Interventional OTHER

Non-Interventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

A prospective consecutive sample of possible stroke cases will be recruited within 12 hours of symptom onset. Final diagnoses may include: ischemic stroke (IS), TIA, aneurysmal subarachnoid hemorrhage (SAH), intracerebral hemorrhage (ICH) with or without intraventricular hemorrhage (IVH) (or primary IVH), and stroke mimic (all other patients presenting with acute onset stroke-like symptoms who do not have ischemic or hemorrhagic stroke).

You may qualify if:

• Patients aged 18 years or older who present with symptoms of a possible stroke in whom blood can be collected for this study within 12 hours of symptom onset will be eligible.

You may not qualify if:

• Age less than 18 years

Sponsors & Collaborators

• Valtari Bio: lead
• University of Cincinnati: collaborator
• University of Texas at Austin: collaborator

Study Sites (2)

University of Cincinnati University Hospital

Cincinnati, Ohio, 45219, United States

Location

University of Texas at Austin

Austin, Texas, 78712, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Venous blood samples will be collected from all patients at baseline resulting in two 2.5 ml Paxgene RNA tubes, two 8 ml EDTA tube, and one 7 ml serum tube. Approximately 28 ml of blood will be collected.

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Taura L Barr, PhD RN

  Valtari Bio

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: April 27, 2016
• Study Start: September 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: April 4, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

US (2)