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MARISS

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MARISS: Mild and Rapidly Improving Stroke Study

Supported by: AHA (GWTG collaboration)

Principal Investigator at BMC: J Rafael Romero, MD

Primary Research Contact: Katie Dam, BA (617-638-9004)

Summary

To understand the long-term outcomes of patients with mild and rapidly improving stroke symptoms, this prospective observational study will leverage the current information in the Get With The Guidelines-Stroke registry and collect 90-day outcomes. A total of 2650 patients with mild and/or rapidly improving stroke symptoms will be enrolled in 100 hospitals participating in GWTG-S. The primary outcome is the proportion of patients with a Modified Rankin Scale ≥2 assessed through a structured telephone interview of stroke outcomes. The feasibility of using an automated web-based patient-reported outcome will be tested in a group of 100 patients. Predictive models and risk scores of poor outcomes will be created. The efficacy and safety outcomes of patients with mild and improving strokes treated with thrombolytics will be explored.

Enrollment Criteria

Inclusion Criteria:

  1. Mild or rapidly improving ischemic stroke, defined clinically and confirmed by neuro-imaging, admitted within 4.5 hours from the onset, that provides informed consent, and speak English or Spanish (outcome measures validated for these two languages). Those with a premorbid mRS >1 will be excluded.
  2. 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.
  3. Mild stroke is defined as an NIHSS of 5 or less.
  4. 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.
  5. Age 18 years or older
  6. Available by telephone and willing to receive two follow-up telephone calls over the next 3 months.

Exclusion Criteria:

  1. Acute stroke patients arriving at the hospital beyond 4.5 hours from symptom onset.
  2. Unable to obtain consent from either patient or legally authorized representative.
  3. Pre-mord Modified Rankin Scale greater than 1.
  4. Not available by telephone.

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.

Status: Pending study closeout