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Trial record 1 of 1 for:    MaRiss
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Mild and Rapidly Improving Stroke Study (MaRISS)

This study is currently recruiting participants.
See Contacts and Locations
Verified April 2017 by Jose Romano, MD, University of Miami
Sponsor:
Collaborator:
American Heart Association
Information provided by (Responsible Party):
Jose Romano, MD, University of Miami
ClinicalTrials.gov Identifier:
NCT02072681
First received: January 9, 2014
Last updated: April 6, 2017
Last verified: April 2017
  Purpose
The objective of this study is to determine the 90-day outcomes of mild and rapidly improving ischemic stroke.

Condition
Ischemic Stroke

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Mild and Rapidly Improving Stroke Study

Further study details as provided by Jose Romano, MD, University of Miami:

Primary Outcome Measures:
  • 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:
  • 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


Estimated Enrollment: 2650
Study Start Date: March 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: August 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts
Mild and Rapidly Improving Ischemic Stroke

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02072681

Contacts
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

  Show 56 Study Locations
Sponsors and Collaborators
University of Miami
American Heart Association
Investigators
Principal Investigator: Jose G Romano, MD University of Miami
  More Information

Responsible Party: Jose Romano, MD, Professor of Clinical Neurology, University of Miami
ClinicalTrials.gov Identifier: NCT02072681     History of Changes
Other Study ID Numbers: 20120079
Study First Received: January 9, 2014
Last Updated: April 6, 2017

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 26, 2017