Validation of Sensitivity and Specificity of a Multi-Omic Precision Diagnostic for Acute Stroke Evaluation
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/6/2019 |
| Start Date: | September 2016 |
| End Date: | December 2019 |
Validation of Sensitivity and Specificity of a Multi-Omic Precision Diagnostic for Acute Stroke Evaluation (VALISS)
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.
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.
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.
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.
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
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials