Ischemic Stroke
Conditions
Brief summary
The objective of this study is to determine the 90-day outcomes of mild and rapidly improving ischemic stroke.
Interventions
None listed
Sponsors
Study design
Eligibility
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Proportion of patients not independent at 30 days | 30 days | Proportion of patients with modified Rankin Scale 2-6 at 30 days. |
| 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 |
| Stroke disability by the Stroke-Impact Scale-16 | 90 days | SIS-16 will be treated as a continuous measure |
| 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 |
| Quality of life by the EuroQOL EQ-5D | 90 days | EuroQOL will be treated as a continuous measure |
Countries
United States