Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| American Heart Association | OTHER |
| Genentech, Inc. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
The objective of this study is to determine the 90-day outcomes of mild and rapidly improving ischemic stroke.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 90 days |
| Symptomatic intracranial hemorrhage due to Alteplase |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jose G Romano, MD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chandler Regional Medical Center | Chandler | Arizona | 85224 | United States | ||
| HonorHealth |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31496438 | Background | 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. | |
| 25642650 | Background | Romano 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 | Proportion of patients with modified Rankin Scale 2-6 at 30 days. | 30 days |
| Quality of life by the EuroQOL EQ-5D | EuroQOL will be treated as a continuous measure | 90 days |
| Stroke disability by the Stroke-Impact Scale-16 | SIS-16 will be treated as a continuous measure | 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 | 90 days |
| 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 |
| 26987870 | Background | Romano 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. |
| 33947209 | Result | Romano 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. |
| 35474180 | Derived | Gardener 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. |
| 34645285 | Derived | Romano 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. |
| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided