Mild and Rapidly Improving Stroke Study
- Conditions
- Ischemic Stroke
- Registration Number
- NCT02072681
- Lead Sponsor
- University of Miami
- Brief Summary
The objective of this study is to determine the 90-day outcomes of mild and rapidly improving ischemic stroke.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2175
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of patients not independent at 90 days 90 days The primary outcome measure is proportion of patients with a modified Rankin Scale of 2-6 at 90 days
- Secondary Outcome Measures
Name Time Method Proportion of patients with dependence or disability in activities of daily living at 90 days 90 days Proportion of patients not independent in activities of daily living defined as a Barthel Index score \<95
Symptomatic intracranial hemorrhage due to Alteplase 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.
Quality of life by the EuroQOL EQ-5D 90 days EuroQOL will be treated as a continuous measure
Stroke disability by the Stroke-Impact Scale-16 90 days SIS-16 will be treated as a continuous measure
Proportion of patients not independent at 30 days 30 days Proportion of patients with modified Rankin Scale 2-6 at 30 days.
Independence with Activities of Daily Living by the Barthel Index 90 days BI will be treated as a continuous measure; pre specified analysis include proportion of patients with Barthel Index \<95
Trial Locations
- Locations (97)
HonorHealth
🇺🇸Scottsdale, Arizona, United States
Southern California Permanente Medical Group / Downey
🇺🇸Pasadena, California, United States
Long Beach Memorial Medical Center
🇺🇸Long Beach, California, United States
Memorial Hospital Central
🇺🇸Colorado Springs, Colorado, United States
Chandler Regional Medical Center
🇺🇸Chandler, Arizona, United States
Medical Center, Navicent Health
🇺🇸Macon, Georgia, United States
WellStar Health System-Kennestone Hospital
🇺🇸Marietta, Georgia, United States
Central DuPage Hospital Association
🇺🇸Winfield, Illinois, United States
Baptist Health Lexington
🇺🇸Lexington, Kentucky, United States
Ocean Medical Center
🇺🇸Brick, New Jersey, United States
Hackensack Meridian Health/Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Osceola Regional Medical Center
🇺🇸Kissimmee, Florida, United States
Lutheran Hospital
🇺🇸Fort Wayne, Indiana, United States
Wesley Medical Center
🇺🇸Wichita, Kansas, United States
Alexian Brothers
🇺🇸Arlington Heights, Illinois, United States
Ascension-Borgess
🇺🇸Kalamazoo, Michigan, United States
Methodist Hospitals
🇺🇸Gary, Indiana, United States
Crouse Hospital
🇺🇸Syracuse, New York, United States
King's Daughters Medical Center
🇺🇸Ashland, Kentucky, United States
Berkshire Medical Center
🇺🇸Pittsfield, Massachusetts, United States
Mercy Hospital St. Louis
🇺🇸Saint Louis, Missouri, United States
Saint Vincent Hospital
🇺🇸Erie, Pennsylvania, United States
Pomona Valley Hospital Medical Center
🇺🇸Pomona, California, United States
The Hospital of Central Connecticut
🇺🇸New Britain, Connecticut, United States
Sacred Heart Hospital
🇺🇸Pensacola, Florida, United States
Memorial Medical Center
🇺🇸Springfield, Illinois, United States
Mississippi Baptist Medical Center
🇺🇸Jackson, Mississippi, United States
St. Joseph's Regional Medical Center
🇺🇸Paterson, New Jersey, United States
The Valley Hospital
🇺🇸Ridgewood, New Jersey, United States
SUNY Downstate Medical Center
🇺🇸Brooklyn, New York, United States
Pennsylvania State University / The Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States
Greenville Memorial Hospital
🇺🇸Greenville, South Carolina, United States
JPS Health Network
🇺🇸Fort Worth, Texas, United States
Clear Lake Regional Medical Center
🇺🇸Webster, Texas, United States
Good Samaritan Hospital
🇺🇸Los Angeles, California, United States
Kaiser Permanente South California
🇺🇸Los Angeles, California, United States
Intermountain Medical Center Neuroscience Institute
🇺🇸Murray, Utah, United States
Ohio State University Wexner Medical Center
🇺🇸Columbus, Ohio, United States
University of Vermont
🇺🇸Burlington, Vermont, United States
Overlake Hospital Medical Center
🇺🇸Bellevue, Washington, United States
West Virginia University
🇺🇸Morgantown, West Virginia, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Seton Medical Center-Brackenridge
🇺🇸Austin, Texas, United States
Jackson Memorial Hospital
🇺🇸Miami, Florida, United States
St. Vincent Hospital Indianapolis
🇺🇸Indianapolis, Indiana, United States
Rochester General Hospital
🇺🇸Rochester, New York, United States
University of Mississippi Medical Center
🇺🇸Jackson, Mississippi, United States
Scott & White Memorial Hospital
🇺🇸Temple, Texas, United States
MetroHealth Medical Center
🇺🇸Cleveland, Ohio, United States
Henry Ford Health System
🇺🇸Detroit, Michigan, United States
Ascencion-St. John Providence
🇺🇸Detroit, Michigan, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
INTEGRIS Baptist Medical Center
🇺🇸Oklahoma City, Oklahoma, United States
Mercy Hospital
🇺🇸Oklahoma City, Oklahoma, United States
Providence St. Vincent
🇺🇸Portland, Oregon, United States
Legacy Emanuel Medical Center
🇺🇸Portland, Oregon, United States
St. Anthony's Medical Center
🇺🇸Saint Louis, Missouri, United States
New York Methodist Hospital
🇺🇸Brooklyn, New York, United States
Univ of Rochester - Strong Memorial Hospital
🇺🇸Rochester, New York, United States
Riverside University Health System Medical Center
🇺🇸Moreno Valley, California, United States
Providence Holy Cross Medical Center
🇺🇸Mission Hills, California, United States
Morton Plant Mease Healthcare
🇺🇸Tampa, Florida, United States
Aurora BayCare Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Aurora Medical Center Grafton
🇺🇸Milwaukee, Wisconsin, United States
Aurora St. Luke's Medical Center
🇺🇸Milwaukee, Wisconsin, United States
Parkview Research Center
🇺🇸Fort Wayne, Indiana, United States
Saint Peter's Hospital
🇺🇸Albany, New York, United States
Orange County Global Medical Center
🇺🇸Santa Ana, California, United States
Eastern Maine Medical Center
🇺🇸Bangor, Maine, United States
Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Mercy Hospital of Buffalo
🇺🇸Buffalo, New York, United States
SSM Health Care St. Louis
🇺🇸Saint Louis, Missouri, United States
Faxton St. Luke's Healthcare
🇺🇸Utica, New York, United States
Cox Medical Centers
🇺🇸Springfield, Missouri, United States
Carolinas HealthCare System
🇺🇸Charlotte, North Carolina, United States
Carolina Healthcare Blue Ridge
🇺🇸Morganton, North Carolina, United States
Kaiser Permanente Northwest Sunnyside Medical Center
🇺🇸Clackamas, Oregon, United States
Saint Francis Hospital
🇺🇸Tulsa, Oklahoma, United States
UPMC Altoona
🇺🇸Altoona, Pennsylvania, United States
UPMC Hamot
🇺🇸Erie, Pennsylvania, United States
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
Bon Secours Hampton Roads
🇺🇸Norfolk, Virginia, United States
Norton HealthCare
🇺🇸Louisville, Kentucky, United States
Novant Forsyth Medical Center
🇺🇸Winston-Salem, North Carolina, United States
Kaiser Permanente Northern California (Sacramento)
🇺🇸Sacramento, California, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Wake Forest University Health Sciences
🇺🇸Winston-Salem, North Carolina, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
Shands Hospital- University of Florida
🇺🇸Gainesville, Florida, United States
The Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
Ochsner Medical Center
🇺🇸New Orleans, Louisiana, United States
St. Luke's Neuroscience Institute
🇺🇸Kansas City, Missouri, United States
Albert Einstein College of Medicine-Montefiore Medical Center
🇺🇸Bronx, New York, United States
Seton Medical Center
🇺🇸Austin, Texas, United States
St. David's Medical Center/Neuro Texas Institute
🇺🇸Austin, Texas, United States
Conemaugh Memorial Medical Center
🇺🇸Johnstown, Pennsylvania, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States