Mild and Rapidly Improving Stroke Study
MaRISS
1 other identifier
observational
2,175
1 country
97
Brief Summary
The objective of this study is to determine the 90-day outcomes of mild and rapidly improving ischemic stroke.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2015
Longer than P75 for all trials
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 9, 2014
CompletedFirst Posted
Study publicly available on registry
February 26, 2014
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2021
CompletedJuly 15, 2021
July 1, 2021
5.8 years
January 9, 2014
July 9, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Proportion of patients not independent at 90 days
The primary outcome measure is proportion of patients with a modified Rankin Scale of 2-6 at 90 days
90 days
Secondary Outcomes (6)
Proportion of patients with dependence or disability in activities of daily living at 90 days
90 days
Symptomatic intracranial hemorrhage due to Alteplase
36 hours
Proportion of patients not independent at 30 days
30 days
Quality of life by the EuroQOL EQ-5D
90 days
Stroke disability by the Stroke-Impact Scale-16
90 days
- +1 more secondary outcomes
Study Arms (1)
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Miamilead
- American Heart Associationcollaborator
- Genentech, Inc.collaborator
Study Sites (97)
Chandler Regional Medical Center
Chandler, Arizona, 85224, United States
HonorHealth
Scottsdale, Arizona, 85258, United States
Long Beach Memorial Medical Center
Long Beach, California, 90806, United States
Good Samaritan Hospital
Los Angeles, California, 90017, United States
Kaiser Permanente South California
Los Angeles, California, 90027, United States
Providence Holy Cross Medical Center
Mission Hills, California, 91345, United States
Riverside University Health System Medical Center
Moreno Valley, California, 92555, United States
Southern California Permanente Medical Group / Downey
Pasadena, California, 91101, United States
Pomona Valley Hospital Medical Center
Pomona, California, 91767, United States
Kaiser Permanente Northern California (Sacramento)
Sacramento, California, 95825, United States
Orange County Global Medical Center
Santa Ana, California, 92705, United States
Memorial Hospital Central
Colorado Springs, Colorado, 80909, United States
The Hospital of Central Connecticut
New Britain, Connecticut, 06050, United States
Shands Hospital- University of Florida
Gainesville, Florida, 32608, United States
Osceola Regional Medical Center
Kissimmee, Florida, 34741, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
Florida Hospital
Orlando, Florida, 32804, United States
Sacred Heart Hospital
Pensacola, Florida, 32504, United States
Morton Plant Mease Healthcare
Tampa, Florida, 33607, United States
Medical Center, Navicent Health
Macon, Georgia, 31201, United States
WellStar Health System-Kennestone Hospital
Marietta, Georgia, 30062, United States
The Queen's Medical Center
Honolulu, Hawaii, 96813, United States
Alexian Brothers
Arlington Heights, Illinois, 60005, United States
Memorial Medical Center
Springfield, Illinois, 62781, United States
Central DuPage Hospital Association
Winfield, Illinois, 60190, United States
Lutheran Hospital
Fort Wayne, Indiana, 46804, United States
Parkview Research Center
Fort Wayne, Indiana, 46845, United States
Methodist Hospitals
Gary, Indiana, 46402, United States
St. Vincent Hospital Indianapolis
Indianapolis, Indiana, 46260, United States
Wesley Medical Center
Wichita, Kansas, 67214, United States
King's Daughters Medical Center
Ashland, Kentucky, 41101, United States
Baptist Health Lexington
Lexington, Kentucky, 40503, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Norton HealthCare
Louisville, Kentucky, 40241, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Berkshire Medical Center
Pittsfield, Massachusetts, 01201, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Ascencion-St. John Providence
Detroit, Michigan, 48236, United States
Spectrum Health
Grand Rapids, Michigan, 49503, United States
Ascension-Borgess
Kalamazoo, Michigan, 49048, United States
Mississippi Baptist Medical Center
Jackson, Mississippi, 39202, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
St. Luke's Neuroscience Institute
Kansas City, Missouri, 64111, United States
Cox Medical Centers
Springfield, Missouri, 65807, United States
SSM Health Care St. Louis
St Louis, Missouri, 63044, United States
St. Anthony's Medical Center
St Louis, Missouri, 63128, United States
Mercy Hospital St. Louis
St Louis, Missouri, 63141, United States
Ocean Medical Center
Brick, New Jersey, 08724, United States
Hackensack Meridian Health/Jersey Shore University Medical Center
Neptune City, New Jersey, 07753, United States
St. Joseph's Regional Medical Center
Paterson, New Jersey, 07503, United States
The Valley Hospital
Ridgewood, New Jersey, 07450, United States
Saint Peter's Hospital
Albany, New York, 12208, United States
SUNY Downstate Medical Center
Brooklyn, New York, 11203, United States
New York Methodist Hospital
Brooklyn, New York, 11215, United States
Mercy Hospital of Buffalo
Buffalo, New York, 10220, United States
Rochester General Hospital
Rochester, New York, 14621, United States
Univ of Rochester - Strong Memorial Hospital
Rochester, New York, 14627, United States
Crouse Hospital
Syracuse, New York, 13210, United States
Albert Einstein College of Medicine-Montefiore Medical Center
The Bronx, New York, 10467, United States
Faxton St. Luke's Healthcare
Utica, New York, 13502, United States
Carolinas HealthCare System
Charlotte, North Carolina, 28203, United States
Carolina Healthcare Blue Ridge
Morganton, North Carolina, 28655, United States
Novant Forsyth Medical Center
Winston-Salem, North Carolina, 27103, United States
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45229, United States
MetroHealth Medical Center
Cleveland, Ohio, 44109, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43202, United States
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
Mercy Hospital
Oklahoma City, Oklahoma, 73120, United States
Saint Francis Hospital
Tulsa, Oklahoma, 74136, United States
Kaiser Permanente Northwest Sunnyside Medical Center
Clackamas, Oregon, 97015, United States
Providence St. Vincent
Portland, Oregon, 97225, United States
Legacy Emanuel Medical Center
Portland, Oregon, 97227, United States
UPMC Altoona
Altoona, Pennsylvania, 16601, United States
Saint Vincent Hospital
Erie, Pennsylvania, 16544, United States
UPMC Hamot
Erie, Pennsylvania, 16550, United States
Pennsylvania State University / The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Conemaugh Memorial Medical Center
Johnstown, Pennsylvania, 15905, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
Greenville Memorial Hospital
Greenville, South Carolina, 29605, United States
Seton Medical Center-Brackenridge
Austin, Texas, 78705, United States
Seton Medical Center
Austin, Texas, 78705, United States
St. David's Medical Center/Neuro Texas Institute
Austin, Texas, 78705, United States
JPS Health Network
Fort Worth, Texas, 76104, United States
Houston Methodist Hospital
Houston, Texas, 77030, United States
Scott & White Memorial Hospital
Temple, Texas, 76508, United States
Clear Lake Regional Medical Center
Webster, Texas, 77598, United States
Intermountain Medical Center Neuroscience Institute
Murray, Utah, 84107, United States
University of Vermont
Burlington, Vermont, 05401, United States
Bon Secours Hampton Roads
Norfolk, Virginia, 23505, United States
Overlake Hospital Medical Center
Bellevue, Washington, 98004, United States
West Virginia University
Morgantown, West Virginia, 26505, United States
Aurora BayCare Medical Center
Milwaukee, Wisconsin, 53233, United States
Aurora Medical Center Grafton
Milwaukee, Wisconsin, 53233, United States
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53233, United States
Related Publications (6)
Romano JG, Gardener H, Campo-Bustillo I, Khan Y, Riley N, Tai S, Sacco RL, Khatri P, Smith EE, Schwamm LH. The Mild and Rapidly Improving Stroke Study (MaRISS): Rationale and design. Int J Stroke. 2019 Dec;14(9):983-986. doi: 10.1177/1747493019873595. Epub 2019 Sep 7.
PMID: 31496438BACKGROUNDRomano JG, Smith EE, Liang L, Gardener H, Camp S, Shuey L, Cook A, Campo-Bustillo I, Khatri P, Bhatt DL, Fonarow GC, Sacco RL, Schwamm LH. Outcomes in mild acute ischemic stroke treated with intravenous thrombolysis: a retrospective analysis of the Get With the Guidelines-Stroke registry. JAMA Neurol. 2015 Apr;72(4):423-31. doi: 10.1001/jamaneurol.2014.4354.
PMID: 25642650BACKGROUNDRomano JG, Smith EE, Liang L, Gardener H, Campo-Bustillo I, Khatri P, Bhatt DL, Fonarow GC, Sacco RL, Schwamm LH. Distinct Short-Term Outcomes in Patients With Mild Versus Rapidly Improving Stroke Not Treated With Thrombolytics. Stroke. 2016 May;47(5):1278-85. doi: 10.1161/STROKEAHA.115.011528. Epub 2016 Mar 17.
PMID: 26987870BACKGROUNDRomano JG, Gardener H, Campo-Bustillo I, Khan Y, Tai S, Riley N, Smith EE, Sacco RL, Khatri P, Alger HM, Mac Grory B, Gulati D, Sangha NS, Craig JM, Olds KE, Benesch CG, Kelly AG, Brehaut SS, Kansara AC, Schwamm LH; MaRISS Investigators*. Predictors of Outcomes in Patients With Mild Ischemic Stroke Symptoms: MaRISS. Stroke. 2021 Jun;52(6):1995-2004. doi: 10.1161/STROKEAHA.120.032809. Epub 2021 May 5.
PMID: 33947209RESULTGardener H, Romano LA, Smith EE, Campo-Bustillo I, Khan Y, Tai S, Riley N, Sacco RL, Khatri P, Alger HM, Mac Grory B, Gulati D, Sangha NS, Olds KE, Benesch CG, Kelly AG, Brehaut SS, Kansara AC, Schwamm LH, Romano JG. Functional status at 30 and 90 days after mild ischaemic stroke. Stroke Vasc Neurol. 2022 Apr 26;7(5):375-80. doi: 10.1136/svn-2021-001333. Online ahead of print.
PMID: 35474180DERIVEDRomano JG, Gardener H, Smith EE, Campo-Bustillo I, Khan Y, Tai S, Riley N, Sacco RL, Khatri P, Alger HM, Mac Grory B, Gulati D, Sangha NS, Olds KE, Benesch CG, Kelly AG, Brehaut SS, Kansara AC, Schwamm LH; MaRISS Investigators*. Frequency and Prognostic Significance of Clinical Fluctuations Before Hospital Arrival in Stroke. Stroke. 2022 Feb;53(2):482-487. doi: 10.1161/STROKEAHA.121.034124. Epub 2021 Oct 14.
PMID: 34645285DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jose G Romano, MD
University of Miami
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Months
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Clinical Neurology
Study Record Dates
First Submitted
January 9, 2014
First Posted
February 26, 2014
Study Start
March 1, 2015
Primary Completion
December 31, 2020
Study Completion
June 30, 2021
Last Updated
July 15, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share