Inpatient trials

TIA or Minor Ischemic Stroke


Single blood draw into PAXgene tubes.

Inclusion Criteria:

  1. 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
  2. Age 40 or older.
  3. Blood draw within 72 hours of TIA/minor stroke onset.

Exclusion Criteria.

  1.  Intracerebral hemorrhage, subarachnoid hemorrhage or other intracerebral lesion by CT or MRI other than positive DWI-MRI
  2.  Lymphoma / leukemia
  3. Blood dyscrasia
  4. Infection requiring antibiotics within 14d prior to TIA or up to 72h after TIA
  5. Immunosuppressive therapy
  6. Current illicit drug use
  7. Blood transfusion within the past 1 month
  8. Major surgery or trauma requiring hospitalization within the past 6 months
  9. Cancer requiring chemotherapy, radiation or surgery within the past year
  10. TIA caused by angiography or surgery
  11. 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

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Inclusion Criteria:

  • 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

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

Three blood draws for stroke/TIA patients

  • Within 8 hours of symptom onset
  • 24 hours (+/-6)
  • 48 hours (+/- 6)