Supported by AHA (GWTG collaboration)
Principal Investigator at BMC: J Rafael Romero, MD
Aim: To elucidate long-term outcomes of patients with mild and rapidly improving stroke and examine the association with tPA treatment. Primary Outcome Measure: Proportion of patients with a mRS = or > 2 at 90 days.
Study duration: 90 days
Observation study: no study drug
- Mild or rapidly improving ischemic stroke, defined clinically and confirmed by neuro-imaging, admitted within 4.5 hours from onset, that provide informed consent, and speak English or Spanish (outcome measures validated for these two languages). Those with a premorbid mRS >1 will be excluded.
- Ischemic stroke is assessed clinically by the stroke team at the eligible hospital by the presence of focal neurological symptoms of sudden onset in the absence of hypoglycemia <50 mg/dl or brain CT evidence of intracerebral hemorrhage. Other clinical and imaging information may be used by the investigator to determine an ischemic etiology for the focal neurological symptoms.
- Mild stroke is defined as an NIHSS of 5 or less.
- Rapidly improving stroke is defined by the site neurologist or stroke team member. There is currently no standard definition for RIS. A variety of definitions have been employed, including: a) NIHSS improvement 4 points from baseline; b) NIHSS 0 or 1 on follow-up or improvement of 8 points from baseline (major neurological improvement); c) NIHSS 3 on follow-up or improvement of 10 points from baseline (dramatic neurological improvement); d) improvement by 20%; and e) improvement by 40% from baseline NIHSS score.
This observational study DOES NOT mandate intervention or treatment, and will enroll patients after the decision has been made to treat or not treat with intravenous rtPA.