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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 : June 7, 2018
Sponsor:
Collaborator:
American Heart Association
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

Study Type : Observational [Patient Registry]
Estimated Enrollment : 2650 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: Mild and Rapidly Improving Stroke Study
Study Start Date : March 2015
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : December 2019

Group/Cohort
Mild and Rapidly Improving Ischemic Stroke



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



Information from the National Library of Medicine

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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.
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

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


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

  Hide Study Locations
Locations
United States, Arizona
Chandler Regional Medical Center Recruiting
Chandler, Arizona, United States, 85224
Contact: Annette Taylor, RN    480-728-5721      
HonorHealth Recruiting
Scottsdale, Arizona, United States, 85258
Contact: Gary Reese, MD    480-882-2941      
United States, California
Long Beach Memorial Medical Center Recruiting
Long Beach, California, United States, 90806
Contact: Francoise Toussaint-Jones, CCRP    562-933-1239    research@memorialcare.org   
Good Samaritan Hospital Recruiting
Los Angeles, California, United States, 90017
Contact: Matthew Tenser, MD    213-977-2289      
Contact: Sarah Burke    (213) 977-2289      
Kaiser Permanente South California Recruiting
Los Angeles, California, United States, 90027
Contact: Catherine L Lui, CCRP    323-783-5752      
Providence Holy Cross Medical Center Recruiting
Mission Hills, California, United States, 91345
Contact: Karen Klein    818-496-9583      
Riverside University Health System Medical Center Recruiting
Moreno Valley, California, United States, 92555
Contact: Haley S. Lee, MPH    951-486-5857      
Southern California Permanente Medical Group / Downey Recruiting
Pasadena, California, United States, 91101
Contact: Navdeep Sangha, MD    323-783-4778      
Contact: Research Associate    323-783-3253      
Pomona Valley Hospital Medical Center Recruiting
Pomona, California, United States, 91767
Contact: Karen Tse-Chang, RN    909-630-7222      
Kaiser Permanente Northern California (Sacramento) Recruiting
Sacramento, California, United States, 95825
Contact: Jonathan Hartman, MD    916-973-5750      
Contact: Ashena Varani, NP    916-973-5750      
Orange County Global Medical Center Recruiting
Santa Ana, California, United States, 92705
Contact: Kimberly Dyer, RN    714-953-2559      
United States, Connecticut
The Hospital of Central Connecticut Recruiting
New Britain, Connecticut, United States, 06050
Contact: Deborah Katten, RN    860-224-5900 ext 2466      
United States, Florida
Shands Hospital- University of Florida Recruiting
Gainesville, Florida, United States, 32608
Contact: Esther Olasoji    352-273-6448      
Osceola Regional Medical Center Recruiting
Kissimmee, Florida, United States, 34741
Contact: Melissa Turner, RN    407-518-3023      
Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Kathy Hesse, ARNP    305-243-8018      
Florida Hospital Recruiting
Orlando, Florida, United States, 32804
Contact: Cherlynn Basignani, RN    407-303-3247      
Sacred Heart Hospital Recruiting
Pensacola, Florida, United States, 32504
Contact: Carrie Hundley    850-416-4842      
Morton Plant Mease Healthcare Recruiting
Tampa, Florida, United States, 33607
Contact: Shawna Miller RN, RN    727-461-8885      
United States, Georgia
Medical Center, Navicent Health Recruiting
Macon, Georgia, United States, 31201
Contact: Matthew Smith, MD    478-633-9436      
WellStar Health System-Kennestone Hospital Recruiting
Marietta, Georgia, United States, 30062
Contact: Ana Gaonkar    470-793-4041      
United States, Hawaii
The Queen's Medical Center Recruiting
Honolulu, Hawaii, United States, 96813
Contact: Cherylee Chang, MD    808-691-7152      
Contact: Clinical Research Nurse    808-691-4428      
United States, Illinois
Alexian Brothers Recruiting
Arlington Heights, Illinois, United States, 60005
Contact: Jennifer Orde    847-981-3630      
Memorial Medical Center Not yet recruiting
Springfield, Illinois, United States, 62781
Contact: Kelly Dunkirk    217-788-3335      
Central DuPage Hospital Association Recruiting
Winfield, Illinois, United States, 60190
Contact: Harish Shownkeen, MD    630-933-5590      
Contact: Neuroscience Coordinator    630-933-6107      
United States, Indiana
Lutheran Hospital Withdrawn
Fort Wayne, Indiana, United States, 46804
Parkview Research Center Recruiting
Fort Wayne, Indiana, United States, 46845
Contact: Tressa Brunner    260-266-5593      
Methodist Hospitals Recruiting
Gary, Indiana, United States, 46402
Contact: Sanjeev Maniar, MD    219-738-4926      
Contact: Clinical Study Coordinator    219-738-4926      
St. Vincent Hospital Indianapolis Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Jeffrey Hilburn Hilburn, MD    317-806-6991      
United States, Kansas
Wesley Medical Center Recruiting
Wichita, Kansas, United States, 67214
Contact: Laura C Bevis, APRN    316-962-3518      
Contact: Cindy Murphy, RN    316-962-3518      
United States, Kentucky
King's Daughters Medical Center Recruiting
Ashland, Kentucky, United States, 41101
Contact: Jenny Nunley    606-408-1728      
Baptist Health Lexington Recruiting
Lexington, Kentucky, United States, 40503
Contact: Linda Breathitt    859-277-6143      
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Ann Jerde, RN    502-852-5251      
Norton HealthCare Recruiting
Louisville, Kentucky, United States, 40241
Contact: Robyn McLean    502-394-6460      
United States, Louisiana
Ochsner Medical Center Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Bethany Jennings, APRN    504-842-2247      
United States, Maine
Eastern Maine Medical Center Recruiting
Bangor, Maine, United States, 04401
Contact: Gillian Gordon-Perue, MD    207-947-0558      
Contact: Research Coordinator    207-973-7596      
United States, Massachusetts
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Contact: Helena Lau, RN    617-414-1171      
Contact: Jose R Romero, MD    617-638-8456      
Berkshire Medical Center Recruiting
Pittsfield, Massachusetts, United States, 01201
Contact: Laurence Ufford, MD    413-395-7694      
United States, Michigan
Ascencion-St. John Providence Recruiting
Detroit, Michigan, United States, 48236
Contact: Lynne Froehlich    586-771-7440      
Spectrum Health Recruiting
Grand Rapids, Michigan, United States, 49503
Contact: Christa Rood    616-486-6079    Christa.Rood@spectrumhealth.org   
Ascension-Borgess Recruiting
Kalamazoo, Michigan, United States, 49048
Contact: Linda Mader    269-226-4816      
United States, Mississippi
Mississippi Baptist Medical Center Recruiting
Jackson, Mississippi, United States, 39202
Contact: Teresa Ellerbusch, RN    601-973-1580      
University of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
Contact: Rebecca Sugg, MD    601-984-5490      
Contact: Susan Hetzel, RN    (601) 984-5518      
United States, Missouri
St. Luke's Neuroscience Institute Recruiting
Kansas City, Missouri, United States, 64111
Contact: Karin Olds, MD    816-531-4080      
Contact: SNLI Coordinators    816-932-9897      
SSM Health Care St. Louis Recruiting
Saint Louis, Missouri, United States, 63044
Contact: Amer Alshekhlee, MD    314-355-3355      
St. Anthony's Medical Center Recruiting
Saint Louis, Missouri, United States, 63128
Contact: Maheen Malik, MD    314-843-4333      
Mercy Hospital St. Louis Recruiting
Saint Louis, Missouri, United States, 63141
Contact: Sally Schoroer, RN    314-251-7703      
Contact: William Logan, MD    314-227-2020      
Cox Medical Centers Recruiting
Springfield, Missouri, United States, 65807
Contact: Richard Jung, MD    417-875-3087      
Contact: Clinical Research Coordinator    417-631-0214      
United States, New Jersey
Ocean Medical Center Recruiting
Brick, New Jersey, United States, 08724
Contact: Baher Goergy    732-776-3498      
Hackensack Meridian Health/Jersey Shore University Medical Center Recruiting
Neptune, New Jersey, United States, 07753
Contact: Jennifer Ortiz    732-776-3460      
St. Joseph's Regional Medical Center Recruiting
Paterson, New Jersey, United States, 07503
Contact: Loretta Hall    973-569-6466      
The Valley Hospital Recruiting
Ridgewood, New Jersey, United States, 07450
Contact: Dorothea Altschul, MD    201-327-8600      
Contact: Nancy Adler, RN    201-447-8453      
United States, New York
Saint Peter's Hospital Recruiting
Albany, New York, United States, 12208
Contact: Maggie Ellithorpe    516-669-2108      
Albert Einstein College of Medicine-Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Margaux Giardino    718-920-6444      
SUNY Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact: Nadege Gilles    718-270-3188      
New York Methodist Hospital Recruiting
Brooklyn, New York, United States, 11215
Contact: Miran Salgado, MD    718-780-5490      
Contact: Stroke Research Coordinator    718-780-3777      
Mercy Hospital of Buffalo Recruiting
Buffalo, New York, United States, 10220
Contact: Cheryl Conover, CRC    716-828-3868      
Rochester General Hospital Recruiting
Rochester, New York, United States, 14621
Contact: Nabil Matmati    585-922-4371      
Univ of Rochester - Strong Memorial Hospital Recruiting
Rochester, New York, United States, 14627
Contact: Curtis Benesch, MD    585-275-2530      
Faxton St. Luke's Healthcare Recruiting
Utica, New York, United States, 13502
Contact: Scott Brehaut, MD    315-624-5705      
United States, North Carolina
Carolinas HealthCare System Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Jerry Martin, MD    704-446-1910      
Contact: Clinical Research    704-446-1910      
Carolina Healthcare Blue Ridge Recruiting
Morganton, North Carolina, United States, 28655
Contact: Joseph Mazzola, MD    828-580-5360      
Contact: Lisa D Landers    (828) 580-5360      
Novant Forsyth Medical Center Recruiting
Winston-Salem, North Carolina, United States, 27103
Contact: Christina Roels, PharmD    336-277-5110      
Wake Forest University Health Sciences Recruiting
Winston-Salem, North Carolina, United States, 27157
Contact: Amy Guzik    336-716-2758      
Contact: Clinical Studies Coordinator    336-716-0308      
United States, Ohio
University of Cincinnati Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Alisha Hodge    513-558-5149      
MetroHealth Medical Center Recruiting
Cleveland, Ohio, United States, 44109
Contact: Dana Cook, RN    216-778-7478      
Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43202
Contact: Weiping Ye    614-688-8817      
United States, Oklahoma
INTEGRIS Baptist Medical Center Recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Bethany Fife, RN    405-951-8604      
Mercy Hospital Recruiting
Oklahoma City, Oklahoma, United States, 73120
Contact: Amber Elliot, RN    405-486-8737      
Saint Francis Hospital Recruiting
Tulsa, Oklahoma, United States, 74136
Contact: Larry Shepherd, MD    918-501-0459      
Contact: Matthew Holzmann    (918) 501-0459      
United States, Oregon
Kaiser Permanente Northwest Sunnyside Medical Center Terminated
Clackamas, Oregon, United States, 97015
Providence St. Vincent Recruiting
Portland, Oregon, United States, 97225
Contact: Robin Kintner    503-216-1017      
Legacy Emanuel Medical Center Recruiting
Portland, Oregon, United States, 97227
Contact: Maryika Gibson, FNP    503-413-1138      
United States, Pennsylvania
UPMC Altoona Recruiting
Altoona, Pennsylvania, United States, 16601
Contact: Janet Asherst    814-889-3206      
Saint Vincent Hospital Recruiting
Erie, Pennsylvania, United States, 16544
Contact: Melanie Henderson, RN    814-452-5968      
UPMC Hamot Recruiting
Erie, Pennsylvania, United States, 16550
Contact: Charles Romero, MD    814-877-5330      
Pennsylvania State University / The Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Raymond Reichwein, MD    717-531-1803      
Conemaugh Memorial Medical Center Recruiting
Johnstown, Pennsylvania, United States, 15905
Contact: Nicholas Lanciano, MD    814-269-5211      
Contact: Clinical Research Coordinator    814-534-1105      
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Brian Silver, MD    401-444-8806      
Contact: Clinical Research Assistant    401-444-2936      
United States, South Carolina
Greenville Memorial Hospital Recruiting
Greenville, South Carolina, United States, 29605
Contact: Yvonne Milligan, RN    864-399-2660      
United States, Texas
Seton Medical Center-Brackenridge Recruiting
Austin, Texas, United States, 78705
Contact: Laura LaChance    512-324-8383      
Seton Medical Center Recruiting
Austin, Texas, United States, 78705
Contact: Patrick Lawrence    512-324-7000 ext 77396      
Contact: Laura LaChance    512-324-7000 ext 83452      
St. David's Medical Center/Neuro Texas Institute Recruiting
Austin, Texas, United States, 78705
Contact: Whitney Foust, RN    512-583-0658      
JPS Health Network Recruiting
Fort Worth, Texas, United States, 76104
Contact: Renee Potter    817-702-3941      
Houston Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Rajan Gadja, MD    713-394-6479      
Contact: Study Coordinator    713-394-6479      
Scott & White Memorial Hospital Recruiting
Temple, Texas, United States, 76508
Contact: Jennifer Rasmussen, MD    254-724-5272      
Contact: Stroke Coordinator    254-724-5076      
Clear Lake Regional Medical Center Recruiting
Webster, Texas, United States, 77598
Contact: Colleen Kehr    281-338-3051      
United States, Utah
Intermountain Medical Center Neuroscience Institute Recruiting
Murray, Utah, United States, 84107
Contact: Jeffrey Turner    801-507-6453      
United States, Vermont
University of Vermont Recruiting
Burlington, Vermont, United States, 05401
Contact: Paul Jarvis    802-656-5175      
United States, Virginia
Bon Secours Hampton Roads Recruiting
Norfolk, Virginia, United States, 23505
Contact: Elizabeth Purrington, MSN    757-278-2171      
United States, Washington
Overlake Hospital Medical Center Recruiting
Bellevue, Washington, United States, 98004
Contact: Kerry Rodgers, RN    425-635-6300      
United States, West Virginia
West Virginia University Recruiting
Morgantown, West Virginia, United States, 26505
Contact: Jay Sherman    304-293-2343      
United States, Wisconsin
Aurora BayCare Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53233
Contact: James Napier, MD    920-288-8100      
Aurora Medical Center Grafton Recruiting
Milwaukee, Wisconsin, United States, 53233
Contact: Rose Dotson, MD    262-329-8600      
Aurora St. Luke's Medical Center Recruiting
Milwaukee, Wisconsin, United States, 53233
Contact: Khaled Asi, MD    414-385-4638      
Sponsors and Collaborators
University of Miami
American Heart Association
Investigators
Principal Investigator: Jose G Romano, MD University of Miami

Responsible Party: Jose Romano, MD, Professor of Clinical Neurology, University of Miami
ClinicalTrials.gov Identifier: NCT02072681     History of Changes
Other Study ID Numbers: 20120079
First Posted: February 26, 2014    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018

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