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 : Active, not recruiting
First Posted : April 27, 2016
Last Update Posted : January 10, 2018
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:
- 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).
- The ability of a multi-omic biomarker profile to differentiate ischemic stroke from hemorrhagic stroke and TIA.
|Condition or disease||Intervention/treatment|
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. Two hundred and fifty patients aged 18 years or older who present to the hospital stroke like symptoms will be recruited within 12 hours of symptom onset at the University of Cincinnati Medical Center (UCMC) and/or participating regional hospitals served by the UC Stroke Team. 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 Type :||Observational|
|Estimated Enrollment :||500 participants|
|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 :||May 2018|
|Estimated Study Completion Date :||May 2018|
- 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
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
|United States, Ohio|
|University of Cincinnati University Hospital|
|Cincinnati, Ohio, United States, 45219|
|United States, Texas|
|University of Texas at Austin|
|Austin, Texas, United States, 78712|
|Principal Investigator:||Taura L Barr, PhD RN||Valtari Bio|