The Mild and Rapidly Improving Stroke Study (MaRISS): Rationale and design

Jose G. Romano, Hannah Gardener, Iszet Campo-Bustillo, Yosef Khan, Nikesha Riley, Sofie Tai, Ralph L. Sacco, Pooja Khatri, Eric E. Smith, Lee H. Schwamm

Research output: Contribution to journalArticle

Abstract

Rationale: Although mild and rapidly improving stroke symptoms are the most common first stroke presentation, this group has been understudied in acute stroke trials. Observational and retrospective studies suggest residual disability in one third of patients. Aims: To elucidate long-term outcomes of patients with mild and rapidly improving stroke, evaluate the predictors of outcome, and examine the association with alteplase treatment. Sample size: The initial estimate of 2650 participants to detect a 9% difference in non-disabled 90-day outcomes between alteplase-treated and untreated participants was revised to 2000 after a pre-planned re-estimation based on actual treatment rates. Methods and design: Prospective observational study of patients with mild ischemic stroke (NIHSS ≤ 5) or rapidly improving stroke symptoms evaluated within 4.5 h from onset. Outcomes: The primary outcome is the proportion of patients with modified Rankin Scale (mRS) ≥ 2 at 90 days; the primary safety outcome is symptomatic hemorrhagic transformation within 36 h among those treated with alteplase. Secondary outcomes include the 90-day Barthel Index, Stroke Impact Scale 16, European Quality of Life scale, mRS at 30 days, and 30- and 90-day mortality. Discussion: MaRISS will define outcomes and their predictors and clarify the effects of alteplase in patients with mild and rapidly improving stroke symptoms, providing clinicians with important information to manage this population.

Original languageEnglish (US)
JournalInternational Journal of Stroke
DOIs
StateAccepted/In press - Jan 1 2019

Fingerprint

Stroke
Tissue Plasminogen Activator
Observational Studies
Sample Size
Retrospective Studies
Quality of Life
Prospective Studies
Safety
Mortality
Therapeutics
Population

Keywords

  • outcome assessment
  • research design
  • Stroke
  • tissue plasminogen activator

ASJC Scopus subject areas

  • Neurology

Cite this

Romano, J. G., Gardener, H., Campo-Bustillo, I., Khan, Y., Riley, N., Tai, S., ... Schwamm, L. H. (Accepted/In press). The Mild and Rapidly Improving Stroke Study (MaRISS): Rationale and design. International Journal of Stroke. https://doi.org/10.1177/1747493019873595

The Mild and Rapidly Improving Stroke Study (MaRISS) : Rationale and design. / Romano, Jose G.; Gardener, Hannah; Campo-Bustillo, Iszet; Khan, Yosef; Riley, Nikesha; Tai, Sofie; Sacco, Ralph L.; Khatri, Pooja; Smith, Eric E.; Schwamm, Lee H.

In: International Journal of Stroke, 01.01.2019.

Research output: Contribution to journalArticle

Romano, Jose G. ; Gardener, Hannah ; Campo-Bustillo, Iszet ; Khan, Yosef ; Riley, Nikesha ; Tai, Sofie ; Sacco, Ralph L. ; Khatri, Pooja ; Smith, Eric E. ; Schwamm, Lee H. / The Mild and Rapidly Improving Stroke Study (MaRISS) : Rationale and design. In: International Journal of Stroke. 2019.
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