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Mild and Rapidly Improving Stroke Study (MaRISS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02072681
Recruitment Status : Completed
First Posted : February 26, 2014
Last Update Posted : July 15, 2021
American Heart Association
Genentech, Inc.
Information provided by (Responsible Party):
Jose Romano, MD, University of Miami

Brief Summary:
The objective of this study is to determine the 90-day outcomes of mild and rapidly improving ischemic stroke.

Condition or disease
Ischemic Stroke

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Study Type : Observational [Patient Registry]
Actual Enrollment : 2175 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Mild and Rapidly Improving Stroke Study
Actual Study Start Date : March 2015
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ischemic Stroke

Mild and Rapidly Improving Ischemic Stroke

Patients 18 years or older with mild or rapidly improving acute ischemic stroke defined clinically. .Absence of non-ischemic conditions neuro-imaging (i.e. absence of hemorrhage or a mass on brain imaging that arrived to the hospital within 4.5 hours after the onset of stroke symptoms.

All participants will have two follow up telephone calls: One at approximately 30 days after the stroke and one at approximately 90 days after the stroke to ask questions about how well participant can carry out usual duties after the stroke, how much assistance do he/she needs to perform your daily activities and how good or bad would he/she considers current health to be.

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. 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

  2. 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.

  3. Proportion of patients not independent at 30 days [ Time Frame: 30 days ]
    Proportion of patients with modified Rankin Scale 2-6 at 30 days.

  4. Quality of life by the EuroQOL EQ-5D [ Time Frame: 90 days ]
    EuroQOL will be treated as a continuous measure

  5. Stroke disability by the Stroke-Impact Scale-16 [ Time Frame: 90 days ]
    SIS-16 will be treated as a continuous measure

  6. 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

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072681

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Sponsors and Collaborators
University of Miami
American Heart Association
Genentech, Inc.
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Principal Investigator: Jose G Romano, MD University of Miami
Additional Information:

Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jose Romano, MD, Professor of Clinical Neurology, University of Miami
ClinicalTrials.gov Identifier: NCT02072681    
Other Study ID Numbers: 20120079
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: July 15, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases