Biomarkers of Acute Stroke in Clinic (BASIC)
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|ClinicalTrials.gov Identifier: NCT03897478|
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : July 8, 2020
The proposed study will investigate the clinical use of the ISCDX test that may differentiate between diverse stroke etiologies as listed below:
Aim 1: Differentiate between cardioembolic and large artery atherosclerotic ischemic strokes, when hemorrhagic stroke is ruled out, as defined by TOAST classification of subtypes of acute ischemic stroke.
Aim 2: In cases of ischemic strokes of unknown or "cryptogenic" etiology, determine the ability of biomarker blood tests to predict etiology between cardioembolic and large artery atherosclerotic.
|Condition or disease||Intervention/treatment|
|Ischemic Stroke Ischemia Atrial Fibrillation Transient Ischemic Attack Transient Cerebrovascular Events Thrombotic Stroke Stroke Stroke, Acute Stroke, Ischemic Stroke, Complication Stroke of Basilar Artery Atherosclerosis Atheroma Cardioembolic Stroke Cardiomyopathies Cardiovascular Stroke Thromboembolism||Diagnostic Test: ISCDX blood test|
Acute ischemic stroke (AIS) is a leading cause of adult mortality and morbidity in the United States, affecting over 800,000 individuals, annually, leaving many with permanent disability. Emergent evaluation, prompt acute treatment, and identification of stroke etiology for secondary prevention are key to decreasing the morbidity and mortality associated with cerebrovascular disease. Key to treatment and prevention is the identification of stroke etiology - large vessel atherosclerosis, cardioembolic phenomenon, or in-situ small vessel cerebrovascular disease - since primary and secondary prevention measures differ based on stroke subtype. The diagnosis of ischemic stroke includes a combination of patient history, clinical assessment, and brain imaging. However, identifying the cause of cerebrovascular ischemia is challenging and routinely assigned of cryptogenic origin.
Therefore, the need is great, to understand the pathogenesis of AIS events in order to develop more effective preventative measures. Recent studies have identified the differential expression of genes in whole blood which may differentiate the major ischemic stroke types. Such differences may help identify AIS events that are more likely to respond to therapy specifically tailored to the major stroke type. Furthermore, by establishing a more robust standard for secondary prevention, future stroke events may be avoided.
BASIC is a multisite prospective study with a estimated enrollment of up to 500 consecutive adult subjects including no more than 50 age, gender and co-morbidity matched controls ("Controls"). Stroke subjects will be recruited from patients who present to the Emergency Department (ED) or hospital with suspected AIS. Research personnel will identify potential patients by responding to "Brain Attack" pages from the ED to the Stroke Team for patients who meet current Brain Attack criteria. Following evaluation by the ED and neurology physicians, the clinical coordinator will verify the patient had a suspected AIS and meets eligibility criteria. The patient or their legal surrogate will be approached for study participation. Written informed consent will be obtained for all subjects enrolled.
Control subjects will be those who present to the Emergency Department for non-stroke reasons but have one or more risk factors for stroke. These subjects will not have a recruitment window. They can be consented as they present to the hospital. Tubes will be marked as controls. In past studies, these have been collected during slow times in the Emergency Department. Once the study has reached 50 controls, the sponsor will stop enrolling for this group. This has been done in the past by sending the sites a communication that the control group quota has been reached.
The recruitment window will be determined by time of symptom onset, time of presentation at ED or hospital, and ability to consent. This will include patients that present within 30 hours of symptom onset or last known normal time and clinical evidence suggesting Acute Ischemic Stroke.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Biomarkers of Acute Stroke in Clinic|
|Actual Study Start Date :||September 1, 2019|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||December 31, 2022|
Ischemic stroke subjects presenting within 30 hours from symptom onset will have al PAX Gene Blood RNA tubes drawn upon arrival to the Emergency Department (if available) or hospital.
Biomarker blood draw
Diagnostic Test: ISCDX blood test
The ISCDX test is based on gene expression changes that occur as a result of the ischemic stroke. When the stroke occurs, the immune system in the body reacts and causes changes in gene expression in several types of cells, including white blood cells, related to activation of innate and adaptive immune systems.
The ISCDX test distinguishes between cardioembolic and large artery atherosclerotic origin of stroke using a gene signature. The pattern or signature of up or down regulation for all genes for a patient determines whether the patient's pattern of gene expression is more like the pattern seen in other cardioembolic patients or more like the pattern seen in patients with large artery atherosclerotic cause of stroke.
Control group subjects will have PAX Gene Blood RNA tubes drawn. Control group matched with ischemic stroke subjects for age, race, gender, smoking history with at least one of the following vascular risk factors: diabetes, hypertension, atrial fibrillation, hyperlipidemia.
Biomarker blood draw
- Comparison of the rates of patients presenting with acute ischemic stroke identified with ISCDX testing with TOAST criteria [ Time Frame: up to 1 year ]The ISCDX test results will be compared to acute ischemic stroke assessment as defined by the TOAST criteria
Biospecimen Retention: Samples Without 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): NCT03897478
|Contact: Judy Morgan, MBA, CCRCfirstname.lastname@example.org|
|Contact: Jeff Juneemail@example.com|
|United States, Ohio|
|Ohio Health Riveside Methodist Hospital||Recruiting|
|Columbus, Ohio, United States, 43214|
|Contact: Jennifer Czerniak, RN 614-566-1254|
|Principal Investigator: William J Hicks, MD|