Ischemic StrokeMaRISSNCT02072681
Mild and Rapidly Improving Stroke Study
An observational study of Ischemic Stroke, run by University of Miami at 97 sites in United States.
Trial summary
The objective of this study is to determine the 90-day outcomes of mild and rapidly improving ischemic stroke. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Stroke
- How many people
- 2,175 participants
- Where
- 97 sitesUnited States
- Study dates
- Mar 2015to 30 Jun 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
97 sites in 1 country.
97 sites in 1 country
United States97 sites
Saint Peter's Hospital
Albany, New York, 12208
UPMC Altoona
Altoona, Pennsylvania, 16601
Alexian Brothers
Arlington Heights, Illinois, 60005
King's Daughters Medical Center
Ashland, Kentucky, 41101
Seton Medical Center-Brackenridge
Austin, Texas, 78705
Seton Medical Center
Austin, Texas, 78705
St. David's Medical Center/Neuro Texas Institute
Austin, Texas, 78705
Eastern Maine Medical Center
Bangor, Maine, 04401
Overlake Hospital Medical Center
Bellevue, Washington, 98004
Boston Medical Center
Boston, Massachusetts, 02118
Ocean Medical Center
Brick, New Jersey, 08724
SUNY Downstate Medical Center
Brooklyn, New York, 11203
New York Methodist Hospital
Brooklyn, New York, 11215
Mercy Hospital of Buffalo
Buffalo, New York, 10220
University of Vermont
Burlington, Vermont, 05401
Chandler Regional Medical Center
Chandler, Arizona, 85224
Carolinas HealthCare System
Charlotte, North Carolina, 28203
University of Cincinnati Medical Center
Cincinnati, Ohio, 45229
Kaiser Permanente Northwest Sunnyside Medical Center
Clackamas, Oregon, 97015
MetroHealth Medical Center
Cleveland, Ohio, 44109
Memorial Hospital Central
Colorado Springs, Colorado, 80909
Ohio State University Wexner Medical Center
Columbus, Ohio, 43202
Henry Ford Health System
Detroit, Michigan, 48202
Ascencion-St. John Providence
Detroit, Michigan, 48236
Saint Vincent Hospital
Erie, Pennsylvania, 16544
UPMC Hamot
Erie, Pennsylvania, 16550
Lutheran Hospital
Fort Wayne, Indiana, 46804
Parkview Research Center
Fort Wayne, Indiana, 46845
JPS Health Network
Fort Worth, Texas, 76104
Shands Hospital- University of Florida
Gainesville, Florida, 32608
Methodist Hospitals
Gary, Indiana, 46402
Spectrum Health
Grand Rapids, Michigan, 49503
Greenville Memorial Hospital
Greenville, South Carolina, 29605
Pennsylvania State University / The Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
The Queen's Medical Center
Honolulu, Hawaii, 96813
Houston Methodist Hospital
Houston, Texas, 77030
St. Vincent Hospital Indianapolis
Indianapolis, Indiana, 46260
Mississippi Baptist Medical Center
Jackson, Mississippi, 39202
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Conemaugh Memorial Medical Center
Johnstown, Pennsylvania, 15905
Ascension-Borgess
Kalamazoo, Michigan, 49048
St. Luke's Neuroscience Institute
Kansas City, Missouri, 64111
Osceola Regional Medical Center
Kissimmee, Florida, 34741
Baptist Health Lexington
Lexington, Kentucky, 40503
Long Beach Memorial Medical Center
Long Beach, California, 90806
Good Samaritan Hospital
Los Angeles, California, 90017
Kaiser Permanente South California
Los Angeles, California, 90027
University of Louisville
Louisville, Kentucky, 40202
Norton HealthCare
Louisville, Kentucky, 40241
Medical Center, Navicent Health
Macon, Georgia, 31201
WellStar Health System-Kennestone Hospital
Marietta, Georgia, 30062
Jackson Memorial Hospital
Miami, Florida, 33136
Aurora BayCare Medical Center
Milwaukee, Wisconsin, 53233
Aurora Medical Center Grafton
Milwaukee, Wisconsin, 53233
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53233
Providence Holy Cross Medical Center
Mission Hills, California, 91345
Riverside University Health System Medical Center
Moreno Valley, California, 92555
Carolina Healthcare Blue Ridge
Morganton, North Carolina, 28655
West Virginia University
Morgantown, West Virginia, 26505
Intermountain Medical Center Neuroscience Institute
Murray, Utah, 84107
Hackensack Meridian Health/Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
The Hospital of Central Connecticut
New Britain, Connecticut, 06050
Ochsner Medical Center
New Orleans, Louisiana, 70121
Bon Secours Hampton Roads
Norfolk, Virginia, 23505
INTEGRIS Baptist Medical Center
Oklahoma City, Oklahoma, 73112
Mercy Hospital
Oklahoma City, Oklahoma, 73120
Florida Hospital
Orlando, Florida, 32804
Southern California Permanente Medical Group / Downey
Pasadena, California, 91101
St. Joseph's Regional Medical Center
Paterson, New Jersey, 07503
Sacred Heart Hospital
Pensacola, Florida, 32504
Berkshire Medical Center
Pittsfield, Massachusetts, 01201
Pomona Valley Hospital Medical Center
Pomona, California, 91767
Providence St. Vincent
Portland, Oregon, 97225
Legacy Emanuel Medical Center
Portland, Oregon, 97227
Rhode Island Hospital
Providence, Rhode Island, 02903
The Valley Hospital
Ridgewood, New Jersey, 07450
Rochester General Hospital
Rochester, New York, 14621
Univ of Rochester - Strong Memorial Hospital
Rochester, New York, 14627
Kaiser Permanente Northern California (Sacramento)
Sacramento, California, 95825
Orange County Global Medical Center
Santa Ana, California, 92705
HonorHealth
Scottsdale, Arizona, 85258
Memorial Medical Center
Springfield, Illinois, 62781
Cox Medical Centers
Springfield, Missouri, 65807
SSM Health Care St. Louis
St Louis, Missouri, 63044
St. Anthony's Medical Center
St Louis, Missouri, 63128
Mercy Hospital St. Louis
St Louis, Missouri, 63141
Crouse Hospital
Syracuse, New York, 13210
Morton Plant Mease Healthcare
Tampa, Florida, 33607
Scott & White Memorial Hospital
Temple, Texas, 76508
Albert Einstein College of Medicine-Montefiore Medical Center
The Bronx, New York, 10467
Saint Francis Hospital
Tulsa, Oklahoma, 74136
Faxton St. Luke's Healthcare
Utica, New York, 13502
Clear Lake Regional Medical Center
Webster, Texas, 77598
Wesley Medical Center
Wichita, Kansas, 67214
Central DuPage Hospital Association
Winfield, Illinois, 60190
Novant Forsyth Medical Center
Winston-Salem, North Carolina, 27103
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
The objective of this study is to determine the 90-day outcomes of mild and rapidly improving ischemic stroke.
- Conditions
- Ischemic Stroke
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 90 days
Secondary outcomes (6)
Proportion of patients with dependence or disability in activities of daily living at 90 days
Proportion of patients not independent in activities of daily living defined as a Barthel Index score <95
Measured: 90 days
Symptomatic intracranial hemorrhage due to Alteplase
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.
Measured: 36 hours
Proportion of patients not independent at 30 days
Proportion of patients with modified Rankin Scale 2-6 at 30 days.
Measured: 30 days
Quality of life by the EuroQOL EQ-5D
EuroQOL will be treated as a continuous measure
Measured: 90 days
Stroke disability by the Stroke-Impact Scale-16
SIS-16 will be treated as a continuous measure
Measured: 90 days
Independence with Activities of Daily Living by the Barthel Index
BI will be treated as a continuous measure; pre specified analysis include proportion of patients with Barthel Index <95
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2014 (estimated)
- Study startMar 2015
- Primary completion31 Dec 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,175 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- American Heart Association, Genentech, Inc.
- Responsible party
- Principal investigator, Jose Romano, MD, University of Miami
- Investigators
- Jose G Romano, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02072681
- Sponsor's protocol ID
- 20120079
- Acronym
- MaRISS
- Status last verified
- Jul 2021
- First submitted
- 9 Jan 2014
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31496438Romano 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.
PubMed 25642650Romano 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.
PubMed 26987870Romano 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.
PubMed 33947209Gardener 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.
PubMed 35474180Romano 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.
PubMed 34645285
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mild and Rapidly Improving Stroke Study
- ClinicalTrials.gov ID
- NCT02072681
- Acronym / sponsor ID
- MaRISS / 20120079
- Conditions
- Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,175 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- American Heart Association, Genentech, Inc.
- Study start
- Mar 2015 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 26 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to determine the 90-day outcomes of mild and rapidly improving ischemic stroke.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Proportion of patients with dependence or disability in activities of daily living at 90 days
Time frame: 90 days
Symptomatic intracranial hemorrhage due to Alteplase
Time frame: 36 hours
Proportion of patients not independent at 30 days
Time frame: 30 days
Quality of life by the EuroQOL EQ-5D
Time frame: 90 days
Stroke disability by the Stroke-Impact Scale-16
Time frame: 90 days
Independence with Activities of Daily Living by the Barthel Index
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2021.
- Background: PubMed 31496438Romano 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.
- Background: PubMed 25642650Romano 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.
- Background: PubMed 26987870Romano 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.
- Results publication: PubMed 33947209Romano 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.
- Derived from this study: PubMed 35474180Gardener 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.
- Derived from this study: PubMed 34645285Romano 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose G Romano, MD principal investigator
University of Miami
97 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ischemic Stroke, run by University of Miami at 97 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 97 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients not independent at 90 days (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02072681, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2021.