Mild and Rapidly Improving Stroke Study

Study Overview
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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.

Official Title
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Mild and Rapidly Improving Stroke Study

Conditions
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Ischemic Stroke

Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mild and Rapidly Improving Ischemic Stroke<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |