- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03897478
Biomarkers of Acute Stroke in Clinic (BASIC)
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.
Study Overview
Status
Conditions
- Ischemia
- Stroke
- Ischemic Stroke
- Atherosclerosis
- Atrial Fibrillation
- Transient Ischemic Attack
- Cardiomyopathies
- Thromboembolism
- Stroke, Ischemic
- Stroke, Acute
- Thrombotic Stroke
- Stroke, Complication
- Cardioembolic Stroke
- Cardiovascular Stroke
- Atheroma
- Stroke of Basilar Artery
- Transient Cerebrovascular Events
Intervention / Treatment
Detailed Description
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
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Judy Morgan, MBA, CCRC
- Phone Number: 513-827-9106
- Email: judy@iscdx.com
Study Contact Backup
- Name: Jeff June
- Phone Number: 513-827-9106
- Email: jeff.june@iscdx.com
Study Locations
-
-
Ohio
-
Columbus, Ohio, United States, 43214
- Recruiting
- Ohio Health Riveside Methodist Hospital
-
Contact:
- Jennifer Czerniak, RN
- Phone Number: 614-566-1254
-
Principal Investigator:
- William J Hicks, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Source of Subject Population:
Ischemic stroke population will be adult patients who present to the Emergency Department or hospital with an acute ischemic strokeor meet the definition of a control subject who meet the inclusion/exclusion criteria.
Controls subjects will be non-neurologic patients who are matched with the stroke patients for age, race, gender and smoking plus one or more of the following co-morbidities or vascular risk factors:
- Diabetes
- Hypertension
- Atrial fibrillation
- Hyperlipidemia
Description
Inclusion Criteria:
- Patients >18 and < 80 years of age.
- Signs and symptoms suggestive of AIS due to cardioembolic, large vessel, or unknown etiology according to TOAST criteria.
- Arrival to the ED within 30 hours of symptom onset or last known normal time and clinical evidence suggesting Acute Ischemic Stroke.
- Head CT or MRI ruling out other pathology such as vascular malformation, hemorrhage, tumor or abscess which would likely be responsible for presenting neurologic symptoms
- Informed consent obtained
Exclusion Criteria:
- Any central nervous system infection, i.e. meningitis or encephalitis in the past 30 days
- Any form of head trauma, stroke or intracranial hemorrhage in the past 30 days
- Any history of primary or metastatic brain cancer
- Active cancer defined as a diagnosis of cancer, within 6 months before enrollment, any treatment for cancer within the previous 6 months, or recurrent or metastatic cancer.
- Autoimmune diseases: such as lupus, rheumatoid arthritis, Crohn's disease, ulcerative colitis
- Active chronic infectious diseases (eg. HIV/AIDS, hepatitis C)
- Any underlying medical condition which in the opinion of the investigator would prohibit the patient from providing informed consent
- Major surgery within three months prior to the index event
- Signs and symptoms suggestive of (i) AIS due to small vessel occlusion (lacune) and other known etiology according to TOAST criteria, as well as (ii) stroke mimics, transient ischemic attacks, or transient neurological events.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Ischemic Stroke
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 |
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
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
up to 1 year
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Necrosis
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Embolism and Thrombosis
- Pathological Conditions, Anatomical
- Arrhythmias, Cardiac
- Brain Ischemia
- Infarction
- Myocardial Infarction
- Stroke
- Ischemic Stroke
- Ischemia
- Ischemic Attack, Transient
- Atrial Fibrillation
- Thromboembolism
- Cardiomyopathies
- Atherosclerosis
- Plaque, Atherosclerotic
- Embolic Stroke
- Thrombotic Stroke
Other Study ID Numbers
- NCT02014896-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Ischemia
-
University Hospital, Strasbourg, FranceTerminatedVascular Surgery | Ischemia-reperfusion | Ischemia PreconditioningFrance
-
Beytepe Murat Erdi Eker State HospitalCompletedAnterior Segment Ischemia (Diagnosis)
-
University Hospital, Strasbourg, FranceCompletedSkeletal Muscle Ischemia | Severe Lower Limb Ischemia | Mitochondrial DysfunctionFrance
-
The First Affiliated Hospital with Nanjing Medical...RecruitingHepatic IschemiaChina
-
Maastricht University Medical CenterUnknownIschemia-ReperfusionNetherlands
-
Egyptian Cerebro-Cardio-Vascular AssociationUnknownRisk Factor, Cardiovascular | Ischemia, Myocardial | Ischemia, Cerebral
-
Technische Universität DresdenRecruitingRetinal IschemiaGermany
-
Centre Hospitalier Universitaire de NiceCompleted
-
Attikon HospitalUniversity Hospital of PatrasCompleted
-
Beth Israel Deaconess Medical CenterWithdrawn
Clinical Trials on ISCDX blood test
-
French National Agency for Research on AIDS and...Completed
-
Pascual Gregori RoigHospital Universitario de la Plana; FUNDACIÓN DAVALOS FLETCHERCompletedHyperbilirubinemia, Neonatal | Anemia Neonatal | Polycythemia SecondarySpain
-
Wingate InstituteTel Aviv UniversityCompleted
-
University Hospital, ToursCompleted
-
Cairo UniversityUnknownClass III Malocclusion | Class II Malocclusion
-
Assistance Publique Hopitaux De MarseilleCompleted
-
Imperial College LondonCompletedHereditary Hemorrhagic Telangiectasia | Pulmonary Arteriovenous MalformationsUnited Kingdom
-
Minovia Therapeutics Ltd.RecruitingMyelodysplastic SyndromesIsrael
-
Centre Hospitalier Universitaire de NīmesRecruitingNeoplasm Metastasis | Colorectal Cancer | Disseminated CancerFrance
-
University Hospital, GenevaHospices Civils de LyonNot yet recruitingAbuse, Child | Protein Disorder, BloodFrance, Switzerland