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Completed

NCT Number: NCT02072681

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chandler Regional Medical Center, Chandler, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • American Heart Association
  • Genentech, Inc.

Registry information

Acronym: MaRISS

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Feb 26, 2014
Registry last updated
Jul 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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