Mild and Rapidly Improving Stroke Study

Completed

• 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

Study Timeline

• Study First Submitted: 2014-01-09
• Study First Submitted QC: 2014-02-24
• Study First Posted: 2014-02-26
• Study Start: 2015-03
• Primary Completion: 2020-12-31
• Study Completion: 2021-06-30
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-09
• Last Update Posted: 2021-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2175

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

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)

Chandler Regional Medical Center; 🇺🇸 Chandler, Arizona, United States

HonorHealth; 🇺🇸 Scottsdale, Arizona, United States

Long Beach Memorial Medical Center; 🇺🇸 Long Beach, California, United States

Good Samaritan Hospital; 🇺🇸 Los Angeles, California, United States

Kaiser Permanente South California; 🇺🇸 Los Angeles, California, United States

Providence Holy Cross Medical Center; 🇺🇸 Mission Hills, California, United States

Riverside University Health System Medical Center; 🇺🇸 Moreno Valley, California, United States

Southern California Permanente Medical Group / Downey; 🇺🇸 Pasadena, California, United States

Pomona Valley Hospital Medical Center; 🇺🇸 Pomona, California, United States

Kaiser Permanente Northern California (Sacramento); 🇺🇸 Sacramento, California, United States

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