Mild and Rapidly Improving Stroke Study (MaRISS)

July 9, 2021 updated by: Jose Romano, MD, University of Miami
The objective of this study is to determine the 90-day outcomes of mild and rapidly improving ischemic stroke.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

2175

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Chandler Regional Medical Center
      • Scottsdale, Arizona, United States, 85258
        • HonorHealth
    • California
      • Long Beach, California, United States, 90806
        • Long Beach Memorial Medical Center
      • Los Angeles, California, United States, 90017
        • Good Samaritan Hospital
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente South California
      • Mission Hills, California, United States, 91345
        • Providence Holy Cross Medical Center
      • Moreno Valley, California, United States, 92555
        • Riverside University Health System Medical Center
      • Pasadena, California, United States, 91101
        • Southern California Permanente Medical Group / Downey
      • Pomona, California, United States, 91767
        • Pomona Valley Hospital Medical Center
      • Sacramento, California, United States, 95825
        • Kaiser Permanente Northern California (Sacramento)
      • Santa Ana, California, United States, 92705
        • Orange County Global Medical Center
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Memorial Hospital Central
    • Connecticut
      • New Britain, Connecticut, United States, 06050
        • The Hospital of Central Connecticut
    • Florida
      • Gainesville, Florida, United States, 32608
        • Shands Hospital- University of Florida
      • Kissimmee, Florida, United States, 34741
        • Osceola Regional Medical Center
      • Miami, Florida, United States, 33136
        • Jackson Memorial Hospital
      • Orlando, Florida, United States, 32804
        • Florida Hospital
      • Pensacola, Florida, United States, 32504
        • Sacred Heart Hospital
      • Tampa, Florida, United States, 33607
        • Morton Plant Mease Healthcare
    • Georgia
      • Macon, Georgia, United States, 31201
        • Medical Center, Navicent Health
      • Marietta, Georgia, United States, 30062
        • WellStar Health System-Kennestone Hospital
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • The Queen's Medical Center
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Alexian Brothers
      • Springfield, Illinois, United States, 62781
        • Memorial Medical Center
      • Winfield, Illinois, United States, 60190
        • Central DuPage Hospital Association
    • Indiana
      • Fort Wayne, Indiana, United States, 46845
        • Parkview Research Center
      • Fort Wayne, Indiana, United States, 46804
        • Lutheran Hospital
      • Gary, Indiana, United States, 46402
        • Methodist Hospitals
      • Indianapolis, Indiana, United States, 46260
        • St. Vincent Hospital Indianapolis
    • Kansas
      • Wichita, Kansas, United States, 67214
        • Wesley Medical Center
    • Kentucky
      • Ashland, Kentucky, United States, 41101
        • King's Daughters Medical Center
      • Lexington, Kentucky, United States, 40503
        • Baptist Health Lexington
      • Louisville, Kentucky, United States, 40202
        • University of Louisville
      • Louisville, Kentucky, United States, 40241
        • Norton Healthcare
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Ochsner Medical Center
    • Maine
      • Bangor, Maine, United States, 04401
        • Eastern Maine Medical Center
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center
      • Pittsfield, Massachusetts, United States, 01201
        • Berkshire Medical Center
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Health System
      • Detroit, Michigan, United States, 48236
        • Ascencion-St. John Providence
      • Grand Rapids, Michigan, United States, 49503
        • Spectrum Health
      • Kalamazoo, Michigan, United States, 49048
        • Ascension-Borgess
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
      • Jackson, Mississippi, United States, 39202
        • Mississippi Baptist Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • St. Luke's Neuroscience Institute
      • Saint Louis, Missouri, United States, 63141
        • Mercy Hospital St. Louis
      • Saint Louis, Missouri, United States, 63044
        • SSM Health Care St. Louis
      • Saint Louis, Missouri, United States, 63128
        • St. Anthony's Medical Center
      • Springfield, Missouri, United States, 65807
        • Cox Medical Centers
    • New Jersey
      • Brick, New Jersey, United States, 08724
        • Ocean Medical Center
      • Neptune, New Jersey, United States, 07753
        • Hackensack Meridian Health/Jersey Shore University Medical Center
      • Paterson, New Jersey, United States, 07503
        • St. Joseph's Regional Medical Center
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
    • New York
      • Albany, New York, United States, 12208
        • Saint Peter's Hospital
      • Bronx, New York, United States, 10467
        • Albert Einstein College of Medicine-Montefiore Medical Center
      • Brooklyn, New York, United States, 11203
        • SUNY Downstate Medical Center
      • Brooklyn, New York, United States, 11215
        • New York Methodist Hospital
      • Buffalo, New York, United States, 10220
        • Mercy Hospital of Buffalo
      • Rochester, New York, United States, 14621
        • Rochester General Hospital
      • Rochester, New York, United States, 14627
        • Univ of Rochester - Strong Memorial Hospital
      • Syracuse, New York, United States, 13210
        • Crouse Hospital
      • Utica, New York, United States, 13502
        • Faxton St. Luke's Healthcare
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Healthcare System
      • Morganton, North Carolina, United States, 28655
        • Carolina Healthcare Blue Ridge
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Health Sciences
      • Winston-Salem, North Carolina, United States, 27103
        • Novant Forsyth Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • University of Cincinnati Medical Center
      • Cleveland, Ohio, United States, 44109
        • MetroHealth Medical Center
      • Columbus, Ohio, United States, 43202
        • Ohio State University Wexner Medical Center
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Integris Baptist Medical Center
      • Oklahoma City, Oklahoma, United States, 73120
        • Mercy Hospital
      • Tulsa, Oklahoma, United States, 74136
        • Saint Francis Hospital
    • Oregon
      • Clackamas, Oregon, United States, 97015
        • Kaiser Permanente Northwest Sunnyside Medical Center
      • Portland, Oregon, United States, 97225
        • Providence St. Vincent
      • Portland, Oregon, United States, 97227
        • Legacy Emanuel Medical Center
    • Pennsylvania
      • Altoona, Pennsylvania, United States, 16601
        • UPMC Altoona
      • Erie, Pennsylvania, United States, 16550
        • UPMC Hamot
      • Erie, Pennsylvania, United States, 16544
        • Saint Vincent Hospital
      • Hershey, Pennsylvania, United States, 17033
        • Pennsylvania State University / The Milton S. Hershey Medical Center
      • Johnstown, Pennsylvania, United States, 15905
        • Conemaugh Memorial Medical Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Rhode Island Hospital
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Memorial Hospital
    • Texas
      • Austin, Texas, United States, 78705
        • Seton Medical Center
      • Austin, Texas, United States, 78705
        • Seton Medical Center-Brackenridge
      • Austin, Texas, United States, 78705
        • St. David's Medical Center/Neuro Texas Institute
      • Fort Worth, Texas, United States, 76104
        • JPS Health Network
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
      • Temple, Texas, United States, 76508
        • Scott & White Memorial Hospital
      • Webster, Texas, United States, 77598
        • Clear Lake Regional Medical Center
    • Utah
      • Murray, Utah, United States, 84107
        • Intermountain Medical Center Neuroscience Institute
    • Vermont
      • Burlington, Vermont, United States, 05401
        • University of Vermont
    • Virginia
      • Norfolk, Virginia, United States, 23505
        • Bon Secours Hampton Roads
    • Washington
      • Bellevue, Washington, United States, 98004
        • Overlake Hospital Medical Center
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • West Virginia University
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53233
        • Aurora St. Luke's Medical Center
      • Milwaukee, Wisconsin, United States, 53233
        • Aurora BayCare Medical Center
      • Milwaukee, Wisconsin, United States, 53233
        • Aurora Medical Center Grafton

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
90 days
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.
36 hours
Proportion of patients not independent at 30 days
Time Frame: 30 days
Proportion of patients with modified Rankin Scale 2-6 at 30 days.
30 days
Quality of life by the EuroQOL EQ-5D
Time Frame: 90 days
EuroQOL will be treated as a continuous measure
90 days
Stroke disability by the Stroke-Impact Scale-16
Time Frame: 90 days
SIS-16 will be treated as a continuous measure
90 days
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
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Genentech, Inc.
American Heart Association

Investigators

  • Principal Investigator: Jose G Romano, MD, University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

June 30, 2021

Study Registration Dates

First Submitted

January 9, 2014

First Submitted That Met QC Criteria

February 24, 2014

First Posted (Estimate)

February 26, 2014

Study Record Updates

Last Update Posted (Actual)

July 15, 2021

Last Update Submitted That Met QC Criteria

July 9, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20120079

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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