Mild and Rapidly Improving Stroke Study

NCT ID: NCT02072681

Last Updated: 2021-07-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2175 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-03-31

Study Completion Date

2021-06-30

Brief Summary

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

Detailed Description

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Conditions

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Ischemic Stroke

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role collaborator

Genentech, Inc.

INDUSTRY

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Jose Romano, MD

Professor of Clinical Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jose G Romano, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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Chandler Regional Medical Center

Chandler, Arizona, United States

Site Status

HonorHealth

Scottsdale, Arizona, United States

Site Status

Long Beach Memorial Medical Center

Long Beach, California, United States

Site Status

Good Samaritan Hospital

Los Angeles, California, United States

Site Status

Kaiser Permanente South California

Los Angeles, California, United States

Site Status

Providence Holy Cross Medical Center

Mission Hills, California, United States

Site Status

Riverside University Health System Medical Center

Moreno Valley, California, United States

Site Status

Southern California Permanente Medical Group / Downey

Pasadena, California, United States

Site Status

Pomona Valley Hospital Medical Center

Pomona, California, United States

Site Status

Kaiser Permanente Northern California (Sacramento)

Sacramento, California, United States

Site Status

Orange County Global Medical Center

Santa Ana, California, United States

Site Status

Memorial Hospital Central

Colorado Springs, Colorado, United States

Site Status

The Hospital of Central Connecticut

New Britain, Connecticut, United States

Site Status

Shands Hospital- University of Florida

Gainesville, Florida, United States

Site Status

Osceola Regional Medical Center

Kissimmee, Florida, United States

Site Status

Jackson Memorial Hospital

Miami, Florida, United States

Site Status

Florida Hospital

Orlando, Florida, United States

Site Status

Sacred Heart Hospital

Pensacola, Florida, United States

Site Status

Morton Plant Mease Healthcare

Tampa, Florida, United States

Site Status

Medical Center, Navicent Health

Macon, Georgia, United States

Site Status

WellStar Health System-Kennestone Hospital

Marietta, Georgia, United States

Site Status

The Queen's Medical Center

Honolulu, Hawaii, United States

Site Status

Alexian Brothers

Arlington Heights, Illinois, United States

Site Status

Memorial Medical Center

Springfield, Illinois, United States

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Central DuPage Hospital Association

Winfield, Illinois, United States

Site Status

Lutheran Hospital

Fort Wayne, Indiana, United States

Site Status

Parkview Research Center

Fort Wayne, Indiana, United States

Site Status

Methodist Hospitals

Gary, Indiana, United States

Site Status

St. Vincent Hospital Indianapolis

Indianapolis, Indiana, United States

Site Status

Wesley Medical Center

Wichita, Kansas, United States

Site Status

King's Daughters Medical Center

Ashland, Kentucky, United States

Site Status

Baptist Health Lexington

Lexington, Kentucky, United States

Site Status

University of Louisville

Louisville, Kentucky, United States

Site Status

Norton HealthCare

Louisville, Kentucky, United States

Site Status

Ochsner Medical Center

New Orleans, Louisiana, United States

Site Status

Eastern Maine Medical Center

Bangor, Maine, United States

Site Status

Boston Medical Center

Boston, Massachusetts, United States

Site Status

Berkshire Medical Center

Pittsfield, Massachusetts, United States

Site Status

Henry Ford Health System

Detroit, Michigan, United States

Site Status

Ascencion-St. John Providence

Detroit, Michigan, United States

Site Status

Spectrum Health

Grand Rapids, Michigan, United States

Site Status

Ascension-Borgess

Kalamazoo, Michigan, United States

Site Status

Mississippi Baptist Medical Center

Jackson, Mississippi, United States

Site Status

University of Mississippi Medical Center

Jackson, Mississippi, United States

Site Status

St. Luke's Neuroscience Institute

Kansas City, Missouri, United States

Site Status

Cox Medical Centers

Springfield, Missouri, United States

Site Status

SSM Health Care St. Louis

St Louis, Missouri, United States

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St. Anthony's Medical Center

St Louis, Missouri, United States

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Mercy Hospital St. Louis

St Louis, Missouri, United States

Site Status

Ocean Medical Center

Brick, New Jersey, United States

Site Status

Hackensack Meridian Health/Jersey Shore University Medical Center

Neptune City, New Jersey, United States

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St. Joseph's Regional Medical Center

Paterson, New Jersey, United States

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The Valley Hospital

Ridgewood, New Jersey, United States

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Saint Peter's Hospital

Albany, New York, United States

Site Status

SUNY Downstate Medical Center

Brooklyn, New York, United States

Site Status

New York Methodist Hospital

Brooklyn, New York, United States

Site Status

Mercy Hospital of Buffalo

Buffalo, New York, United States

Site Status

Rochester General Hospital

Rochester, New York, United States

Site Status

Univ of Rochester - Strong Memorial Hospital

Rochester, New York, United States

Site Status

Crouse Hospital

Syracuse, New York, United States

Site Status

Albert Einstein College of Medicine-Montefiore Medical Center

The Bronx, New York, United States

Site Status

Faxton St. Luke's Healthcare

Utica, New York, United States

Site Status

Carolinas HealthCare System

Charlotte, North Carolina, United States

Site Status

Carolina Healthcare Blue Ridge

Morganton, North Carolina, United States

Site Status

Novant Forsyth Medical Center

Winston-Salem, North Carolina, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

University of Cincinnati Medical Center

Cincinnati, Ohio, United States

Site Status

MetroHealth Medical Center

Cleveland, Ohio, United States

Site Status

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status

INTEGRIS Baptist Medical Center

Oklahoma City, Oklahoma, United States

Site Status

Mercy Hospital

Oklahoma City, Oklahoma, United States

Site Status

Saint Francis Hospital

Tulsa, Oklahoma, United States

Site Status

Kaiser Permanente Northwest Sunnyside Medical Center

Clackamas, Oregon, United States

Site Status

Providence St. Vincent

Portland, Oregon, United States

Site Status

Legacy Emanuel Medical Center

Portland, Oregon, United States

Site Status

UPMC Altoona

Altoona, Pennsylvania, United States

Site Status

Saint Vincent Hospital

Erie, Pennsylvania, United States

Site Status

UPMC Hamot

Erie, Pennsylvania, United States

Site Status

Pennsylvania State University / The Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Site Status

Conemaugh Memorial Medical Center

Johnstown, Pennsylvania, United States

Site Status

Rhode Island Hospital

Providence, Rhode Island, United States

Site Status

Greenville Memorial Hospital

Greenville, South Carolina, United States

Site Status

Seton Medical Center-Brackenridge

Austin, Texas, United States

Site Status

Seton Medical Center

Austin, Texas, United States

Site Status

St. David's Medical Center/Neuro Texas Institute

Austin, Texas, United States

Site Status

JPS Health Network

Fort Worth, Texas, United States

Site Status

Houston Methodist Hospital

Houston, Texas, United States

Site Status

Scott & White Memorial Hospital

Temple, Texas, United States

Site Status

Clear Lake Regional Medical Center

Webster, Texas, United States

Site Status

Intermountain Medical Center Neuroscience Institute

Murray, Utah, United States

Site Status

University of Vermont

Burlington, Vermont, United States

Site Status

Bon Secours Hampton Roads

Norfolk, Virginia, United States

Site Status

Overlake Hospital Medical Center

Bellevue, Washington, United States

Site Status

West Virginia University

Morgantown, West Virginia, United States

Site Status

Aurora BayCare Medical Center

Milwaukee, Wisconsin, United States

Site Status

Aurora Medical Center Grafton

Milwaukee, Wisconsin, United States

Site Status

Aurora St. Luke's Medical Center

Milwaukee, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 31496438 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25642650 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26987870 (View on PubMed)

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.

Reference Type RESULT
PMID: 33947209 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35474180 (View on PubMed)

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.

Reference Type DERIVED
PMID: 34645285 (View on PubMed)

Other Identifiers

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20120079

Identifier Type: -

Identifier Source: org_study_id

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