TIA or Minor Ischemic Stroke
TIA/minor stroke BIOMARKER STUDY
Single blood draw into PAXgene tubes.
- Suspected TIA or minor stroke (NIHSS 4 or less), mimics okay and encouraged – you don’t have to be sure its a TIA or stroke, just sure enough to plan a work-up
- Age 40 or older.
- Blood draw within 72 hours of TIA/minor stroke onset.
- Intracerebral hemorrhage, subarachnoid hemorrhage or other intracerebral lesion by CT or MRI other than positive DWI-MRI
- Lymphoma / leukemia
- Blood dyscrasia
- Infection requiring antibiotics within 14d prior to TIA or up to 72h after TIA
- Immunosuppressive therapy
- Current illicit drug use
- Blood transfusion within the past 1 month
- Major surgery or trauma requiring hospitalization within the past 6 months
- Cancer requiring chemotherapy, radiation or surgery within the past year
- TIA caused by angiography or surgery
- Treatment with IV-tPA
Acute Ischemic Stroke
Intensive glucose control with target glucose 80-130 vs routine target <180 in patients with NIHSS 3 – 22 and history of DM with glucose >110 or no DM and glucose >150 within 12 hours of symptom onset. Use initial fingerstick glucose
SHINE Study Hotline 800-915-7320
*On-call staff CANNOT assist with I-SPOT
- Age 18 years or older
- Clinical diagnosis of ischemic stroke
- Neuroimaging excludes intracranial hemorrhage (ICH)
- Protocol treatment must begin within 12 hours after stroke symptom It is recommended, but not required, that treatment start within 3 hours of hospital arrival.
- Known history of type 2 diabetes mellitus and glucose >110 mg/dL OR admission glucose ≥150 mg/dL in those w/o known diabetes mellitus (based on most recent finger stick blood glucose at participating site).
- Baseline NIHSS score of 3-22(NIHSS must be assessed within 30 minutes prior to randomization. Randomization will be blocked if subject intubated.)
- Pre-stroke modified Rankin Scale score = 0 for patients with an NIHSS score of 3-7
- Pre-stroke modified Rankin Scale score = 0 or 1 for patients with an NIHSS score of 8-22
- Type 1 diabetes mellitus
- Substantial pre-existing neurological or psychiatric illness that would confound the neurological assessment or other outcome assessment
- Experimental therapy for the enrollment stroke. IV tPA (up to 4.5 hrs) or IA tPA are allowed as are IA therapies including use of FDA cleared devices. Non FDA cleared devices are considered experimental and are excluded.
- Known to be pregnant or breast-feeding at the time of study entry
- Other serious conditions that make the patient unlikely to survive 90 days
- Renal dialysis (including hemo or peritoneal dialysis)
Lab kits located in ED box, in S9 office (instructions for blood draw in lab kit)
- Stroke or TIA within 24 hours of onset
- Patients >18 years of age
- Signs and symptoms suggestive of AIS or TIA
- Within 24 hrs of symptom onset or last known normal time
- 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
- 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
Three blood draws for stroke/TIA patients
- Within 8 hours of symptom onset
- 24 hours (+/-6)
- 48 hours (+/- 6)
***TUBES CAN STAY AT ROOM TEMP UP TO 72 HOURS BEFORE FREEZING**
- Ischemic stroke due to small vessel disease, large vessel cervical or intracranial atherosclerosis within the past 10 days
- 60 years of age or older, or age 50 to 59 years plus a documented medical history of at least one of the following additional risk factors for stroke:
- Congestive heartfailure
- Hypertension (Systolic Blood Pressure >140)
- Diabetes Mellitus
- Prior Stroke (>90 days ago, other than study qualifying indexevent)
- Vascular disease (e.g. coronary artery disease, heart attack, peripheral artery disease and complex aortic plaque)
- cryptogenic stroke
- cardioembolic stroke
- untreated hyperthyroidism
- recent myocardial infarction <1 month of stroke
- recent cardiac surgery (e.g. coronary artery bypass surgery (CABG)) <1 month of stroke
- mechanical heart valve
- valvular disease requiring immediate surgical intervention
- history of atrial fibrillation or atrial flutter
- permanent indication for oral anticoagulation
Acute Intracerebral Hemorrhage
ICH patients eligible for inclusion in this study must fulfill all of the following criteria:
- Aged 18 to 80 years (inclusive)
- Spontaneous, supratentorial intracerebral hemorrhage in deep brain structures (putamen, thalamus, caudate, and associated deep white matter tracts) with a volume ≥ 10 mL but ≤ 30 mL (calculated by the ABC/2 method) determined by routine clinical MRI or CT.
- < 24 hrs from last known normal
- Glasgow Coma Scale (GCS) best motor score no less than 6.
- Use of other investigational drugs within 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline (for biologics), whichever is longer.
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (e.g., fingolimod).
- Current use of concomitant medications with potent CYP2C9/3A4 inhibitory or induction potential.
- Necessity for mechanical ventilation at screening.
- Infratentorial (midbrain, pons, medulla, or cerebellum) or superficial cortical (lobar) ICH.
- Candidates for surgical hematoma evacuation or other urgent surgical intervention (i.e., surgical relief of increased intracranial pressure) on initial presentation. If during the treatment period surgical hematoma evacuation or surgical intervention to lower intracranial pressure becomes indicated, the investigational treatment should be stopped.
- Patients with intraventricular hematoma extension, with or without hydrocephalus, on initial presentation.
- Secondary ICH due to:
– brain tumor
– arteriovenous malformation
– thrombocytopenia, defined as platelet count of <150,000/µl
– known history of coagulopathy
– acute sepsis
– traumatic brain injury (TBI)
– disseminated intravascular coagulation (DIC)
- Prior disability due to other disease compromising mRS evaluation defined as an estimated mRS score (by history) of ≥ 3 before ICH.
- Preexisting unstable epilepsy.
- Patients with active systemic bacterial, viral or fungal infections.
- Concomitant drug-related exclusion criteria:
- Intravenous immunoglobulin, immunosuppressive and/or chemotherapeutic medications.
- Moderate immunosuppressives (e.g. azathioprine, methotrexate) and/or fingolimod within 2 months prior to randomization.
- Stronger immunosuppressives (e.g. cyclophosphamide, immunosuppressive mAb) within (minimally) 6 months prior to randomization, or longer with long-lasting immunosuppressive medications as determined by the investigator.
- Cardiovascular exclusion criteria:
- Cardiac conduction or rhythm disorders including sinus arrest or sino-atrial block, heart rate <50 bpm, sick-sinus syndrome, Mobitz Type II second degree AV block or higher grade AV block, or preexisting atrial fibrillation (either by history or observed at screening).
- PR interval >220 msec. Long QT syndrome or QTcF prolongation >450 msec in males or >470 msec in females on screening electrocardiogram (ECG).
- Patients receiving treatment with QT-prolonging drugs having a long half-life (e.g., amiodarone).
- Any of the following abnormal laboratory values prior to randomization:
- White blood cell (WBC) count < 2,000/μl (< 2.0 x 109/L)
- Lymphocyte count < 800/μl (< 0.8 x 109/L)
- Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test.
- Patients with any other medically unstable condition or serious laboratory abnormality as determined by the investigator.