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Mild and Rapidly Improving Stroke Study (MaRISS)

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ClinicalTrials.gov Identifier: NCT02072681
Recruitment Status : Recruiting
First Posted : February 26, 2014
Last Update Posted : November 9, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

January 9, 2014
February 26, 2014
November 9, 2017
March 2015
August 2018   (Final data collection date for primary outcome measure)
Proportion of patients not independent at 90 days [ Time Frame: 90 days ]
The primary outcome measure is proportion of patients with a modified Rankin Scale of 2-6 at 90 days
Same as current
Complete list of historical versions of study NCT02072681 on ClinicalTrials.gov Archive Site
  • Proportion of patients with dependence or disability in activities of daily living at 90 days [ Time Frame: 90 days ]
    Proportion of patients not independent in activities of daily living defined as a Barthel Index score <95
  • Symptomatic intracranial hemorrhage due to Alteplase [ Time Frame: 36 hours ]
    Amongst those that receive intravenous Alteplase, a secondary safety measure is the proportion of patients that develop neurologic worsening development of symptomatic intracerebral hemorrhage, defined as neurological deterioration that, in the judgment of the investigator, is related to intracranial hemorrhage confirmed by CT or MRI, within 36 hours of administration of Alteplase.
  • Proportion of patients not independent at 30 days [ Time Frame: 30 days ]
    Proportion of patients with modified Rankin Scale 2-6 at 30 days.
  • Quality of life by the EuroQOL EQ-5D [ Time Frame: 90 days ]
    EuroQOL will be treated as a continuous measure
  • Stroke disability by the Stroke-Impact Scale-16 [ Time Frame: 90 days ]
    SIS-16 will be treated as a continuous measure
  • Independence with Activities of Daily Living by the Barthel Index [ Time Frame: 90 days ]
    BI will be treated as a continuous measure; pre specified analysis include proportion of patients with Barthel Index <95
Same as current
Not Provided
Not Provided
 
Mild and Rapidly Improving Stroke Study
Mild and Rapidly Improving Stroke Study
The objective of this study is to determine the 90-day outcomes of mild and rapidly improving ischemic stroke.
Not Provided
Observational [Patient Registry]
Observational Model: Cohort
Time Perspective: Prospective
3 Months
Not Provided
Non-Probability Sample
Patients with ischemic stroke defined clinically as mild and/or spontaneously rapidly improving and confirmed by neuroimaging not to have a hemorrhagic stroke with symptom onset within 4.5 hours.
Ischemic Stroke
Not Provided
Mild and Rapidly Improving Ischemic Stroke
Not Provided
 
Recruiting
2650
December 2018
August 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Mild or spontaneously rapidly improving ischemic stroke confirmed by neuroimaging
  • Arrival to hospital within 4.5 hours of symptom onset
  • Willing to provide consent
  • Available for a telephone interview at 30 and 90 days

Exclusion Criteria:

  • Onset >4.5 hours
  • Unable to provide informed consent (patient or legally appointed representative
  • Premorbid modified Rankin Scale >1
  • Unavailable by telephone for follow-up
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Jose G Romano, MD 305-243-8018 jromano@med.miami.edu
Contact: Iszet Campo-Bustillo, MD, MPH 305-243-8018 icampo@med.miami.edu
United States
 
 
NCT02072681
20120079
No
Not Provided
Not Provided
Jose Romano, MD, University of Miami
University of Miami
American Heart Association
Principal Investigator: Jose G Romano, MD University of Miami
University of Miami
November 2017