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

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ClinicalTrials.gov Identifier: NCT02753257
Recruitment Status : Recruiting
First Posted : April 27, 2016
Last Update Posted : July 6, 2018
Sponsor:
Collaborators:
University of Cincinnati
University of Texas at Austin
Information provided by (Responsible Party):
Valtari Bio

Study Description
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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. 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. The ability of a multi-omic biomarker profile to differentiate ischemic stroke from hemorrhagic stroke and TIA.

Condition or disease Intervention/treatment
Stroke Other: Non-Interventional

Detailed Description:

At the completion of this project the investigators will have evaluated a peripheral blood test that determines the expression of a multi-omic biomarker profile to differentiate stroke from no-stroke in the emergency setting. Five hundred patients aged 18 years or older who present to the hospital with stroke-like symptoms will be recruited within 24 hours of symptom onset at participating clinical sites. Data will be obtained from the medical records. Blood for research purposes will be obtained. Research evaluations for stroke severity, symptoms and outcome will be performed by trained personnel. All clinical evaluation and management will be per standard of care.

The primary outcome of this study is the criterion standard stroke diagnosis. This will be used to estimate the diagnostic test characteristics of a multi-omic biomarker profile in the peripheral whole blood for distinguishing stroke (IS, TIA, SAH, ICH) versus non-stroke in ED patients with acute neurologic symptoms. Secondly, the investigators will estimate the ability of the multi-omic biomarker profile to differentiate between stroke subtypes. A diagnosis of stroke will be defined as clinical syndromes consistent with stroke (i.e., sudden onset neurological deficit) plus imaging confirmation (or symptom resolution and lack of imaging findings in TIA). Finally, the investigators will explore the relationship between the multi-omic profile and time from symptom onset in ischemic stroke patients. Descriptive and inferential statistics will be used to address the aims of the study. Pattern recognition analysis and machine learning will be employed as a systems level approach to determine relevant pathophysiologic pathways associated with diagnosis and symptom onset time.


Study Design
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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validation of Sensitivity and Specificity of a Multi-Omic Precision Diagnostic for Acute Stroke Evaluation (VALISS)
Study Start Date : September 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018
Groups and Cohorts
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Intervention Details:
  • Other: Non-Interventional
    Non-Interventional

Outcome Measures
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Primary Outcome Measures :
  1. Evidence of clinically definite ischemic stroke (focal neurological deficits persisting for more than 24 hours) confirmed by non-investigational CT or MRI [ Time Frame: within the first 24 hours of emergency evaluation ]

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.

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Age less than 18 years
Contacts and Locations
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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): NCT02753257


Contacts
Contact: Taura L Barr, PhD, RN 724-710-0541 tbarr@valtaribio.com

Locations
United States, Ohio
University of Cincinnati University Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Contact: Opeolu M Adeoye, MD    513-558-5281    opeolu.adeoye@uc.edu   
Contact: Arthur Pancioli    513-558-8087    arthur.pancioli@uc.edu   
United States, Texas
University of Texas at Austin Not yet recruiting
Austin, Texas, United States, 78712
Contact: Truman J Milling, MD    512-324-7000 ext 83452    tmilling@seton.org   
Sponsors and Collaborators
Valtari Bio
University of Cincinnati
University of Texas at Austin
Investigators
Principal Investigator: Taura L Barr, PhD RN Valtari Bio
More Information
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Responsible Party: Valtari Bio
ClinicalTrials.gov Identifier: NCT02753257     History of Changes
Other Study ID Numbers: ValtariBio-5-01
First Posted: April 27, 2016    Key Record Dates
Last Update Posted: July 6, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Valtari Bio:
stroke
stroke mimic

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases