Clinical trial NCT02072681: Mild and Rapidly Improving Stroke Study
Official title: Mild and Rapidly Improving Stroke Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ischemic Stroke
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: American Heart Association
name: Genentech, Inc.
First posted: 2014-02-26
Enrollment: 2175
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: The objective of this study is to determine the 90-day outcomes of mild and rapidly improving ischemic stroke.


Eligibility 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

Primary outcomes:
measure: Proportion of patients not independent at 90 days
timeFrame: 90 days
Secondary outcomes:
measure: Proportion of patients with dependence or disability in activities of daily living at 90 days
timeFrame: 90 days
measure: Symptomatic intracranial hemorrhage due to Alteplase
timeFrame: 36 hours
measure: Proportion of patients not independent at 30 days
timeFrame: 30 days
measure: Quality of life by the EuroQOL EQ-5D
timeFrame: 90 days
measure: Stroke disability by the Stroke-Impact Scale-16
timeFrame: 90 days
measure: Independence with Activities of Daily Living by the Barthel Index
timeFrame: 90 days
Other outcomes:
Locations:
city: Chandler
country: United States
facility: Chandler Regional Medical Center
state: Arizona
city: Scottsdale
country: United States
facility: HonorHealth
state: Arizona
city: Long Beach
country: United States
facility: Long Beach Memorial Medical Center
state: California
city: Los Angeles
country: United States
facility: Good Samaritan Hospital
state: California
city: Los Angeles
country: United States
facility: Kaiser Permanente South California
state: California
city: Mission Hills
country: United States
facility: Providence Holy Cross Medical Center
state: California
city: Moreno Valley
country: United States
facility: Riverside University Health System Medical Center
state: California
city: Pasadena
country: United States
facility: Southern California Permanente Medical Group / Downey
state: California
city: Pomona
country: United States
facility: Pomona Valley Hospital Medical Center
state: California
city: Sacramento
country: United States
facility: Kaiser Permanente Northern California (Sacramento)
state: California
city: Santa Ana
country: United States
facility: Orange County Global Medical Center
state: California
city: Colorado Springs
country: United States
facility: Memorial Hospital Central
state: Colorado
city: New Britain
country: United States
facility: The Hospital of Central Connecticut
state: Connecticut
city: Gainesville
country: United States
facility: Shands Hospital- University of Florida
state: Florida
city: Kissimmee
country: United States
facility: Osceola Regional Medical Center
state: Florida
city: Miami
country: United States
facility: Jackson Memorial Hospital
state: Florida
city: Orlando
country: United States
facility: Florida Hospital
state: Florida
city: Pensacola
country: United States
facility: Sacred Heart Hospital
state: Florida
city: Tampa
country: United States
facility: Morton Plant Mease Healthcare
state: Florida
city: Macon
country: United States
facility: Medical Center, Navicent Health
state: Georgia
city: Marietta
country: United States
facility: WellStar Health System-Kennestone Hospital
state: Georgia
city: Honolulu
country: United States
facility: The Queen's Medical Center
state: Hawaii
city: Arlington Heights
country: United States
facility: Alexian Brothers
state: Illinois
city: Springfield
country: United States
facility: Memorial Medical Center
state: Illinois
city: Winfield
country: United States
facility: Central DuPage Hospital Association
state: Illinois
city: Fort Wayne
country: United States
facility: Lutheran Hospital
state: Indiana
city: Fort Wayne
country: United States
facility: Parkview Research Center
state: Indiana
city: Gary
country: United States
facility: Methodist Hospitals
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Hospital Indianapolis
state: Indiana
city: Wichita
country: United States
facility: Wesley Medical Center
state: Kansas
city: Ashland
country: United States
facility: King's Daughters Medical Center
state: Kentucky
city: Lexington
country: United States
facility: Baptist Health Lexington
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Louisville
country: United States
facility: Norton HealthCare
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Medical Center
state: Louisiana
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
city: Pittsfield
country: United States
facility: Berkshire Medical Center
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Detroit
country: United States
facility: Ascencion-St. John Providence
state: Michigan
city: Grand Rapids
country: United States
facility: Spectrum Health
state: Michigan
city: Kalamazoo
country: United States
facility: Ascension-Borgess
state: Michigan
city: Jackson
country: United States
facility: Mississippi Baptist Medical Center
state: Mississippi
city: Jackson
country: United States
facility: University of Mississippi Medical Center
state: Mississippi
city: Kansas City
country: United States
facility: St. Luke's Neuroscience Institute
state: Missouri
city: Saint Louis
country: United States
facility: SSM Health Care St. Louis
state: Missouri
city: Saint Louis
country: United States
facility: St. Anthony's Medical Center
state: Missouri
city: Saint Louis
country: United States
facility: Mercy Hospital St. Louis
state: Missouri
city: Springfield
country: United States
facility: Cox Medical Centers
state: Missouri
city: Brick
country: United States
facility: Ocean Medical Center
state: New Jersey
city: Neptune
country: United States
facility: Hackensack Meridian Health/Jersey Shore University Medical Center
state: New Jersey
city: Paterson
country: United States
facility: St. Joseph's Regional Medical Center
state: New Jersey
city: Ridgewood
country: United States
facility: The Valley Hospital
state: New Jersey
city: Albany
country: United States
facility: Saint Peter's Hospital
state: New York
city: Bronx
country: United States
facility: Albert Einstein College of Medicine-Montefiore Medical Center
state: New York
city: Brooklyn
country: United States
facility: SUNY Downstate Medical Center
state: New York
city: Brooklyn
country: United States
facility: New York Methodist Hospital
state: New York
city: Buffalo
country: United States
facility: Mercy Hospital of Buffalo
state: New York
city: Rochester
country: United States
facility: Rochester General Hospital
state: New York
city: Rochester
country: United States
facility: Univ of Rochester - Strong Memorial Hospital
state: New York
city: Syracuse
country: United States
facility: Crouse Hospital
state: New York
city: Utica
country: United States
facility: Faxton St. Luke's Healthcare
state: New York
city: Charlotte
country: United States
facility: Carolinas HealthCare System
state: North Carolina
city: Morganton
country: United States
facility: Carolina Healthcare Blue Ridge
state: North Carolina
city: Winston-Salem
country: United States
facility: Novant Forsyth Medical Center
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth Medical Center
state: Ohio
city: Columbus
country: United States
facility: Ohio State University Wexner Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: INTEGRIS Baptist Medical Center
state: Oklahoma
city: Oklahoma City
country: United States
facility: Mercy Hospital
state: Oklahoma
city: Tulsa
country: United States
facility: Saint Francis Hospital
state: Oklahoma
city: Clackamas
country: United States
facility: Kaiser Permanente Northwest Sunnyside Medical Center
state: Oregon
city: Portland
country: United States
facility: Providence St. Vincent
state: Oregon
city: Portland
country: United States
facility: Legacy Emanuel Medical Center
state: Oregon
city: Altoona
country: United States
facility: UPMC Altoona
state: Pennsylvania
city: Erie
country: United States
facility: Saint Vincent Hospital
state: Pennsylvania
city: Erie
country: United States
facility: UPMC Hamot
state: Pennsylvania
city: Hershey
country: United States
facility: Pennsylvania State University / The Milton S. Hershey Medical Center
state: Pennsylvania
city: Johnstown
country: United States
facility: Conemaugh Memorial Medical Center
state: Pennsylvania
city: Providence
country: United States
facility: Rhode Island Hospital
state: Rhode Island
city: Greenville
country: United States
facility: Greenville Memorial Hospital
state: South Carolina
city: Austin
country: United States
facility: Seton Medical Center-Brackenridge
state: Texas
city: Austin
country: United States
facility: Seton Medical Center
state: Texas
city: Austin
country: United States
facility: St. David's Medical Center/Neuro Texas Institute
state: Texas
city: Fort Worth
country: United States
facility: JPS Health Network
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Temple
country: United States
facility: Scott & White Memorial Hospital
state: Texas
city: Webster
country: United States
facility: Clear Lake Regional Medical Center
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center Neuroscience Institute
state: Utah
city: Burlington
country: United States
facility: University of Vermont
state: Vermont
city: Norfolk
country: United States
facility: Bon Secours Hampton Roads
state: Virginia
city: Bellevue
country: United States
facility: Overlake Hospital Medical Center
state: Washington
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
city: Milwaukee
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora Medical Center Grafton
state: Wisconsin
city: Milwaukee
country: United States
facility: Aurora St. Luke's Medical Center
state: Wisconsin
Study officials:
affiliation: University of Miami
name: Jose G Romano, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.