Mild and Rapidly Improving Stroke Study (MaRISS)
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|ClinicalTrials.gov Identifier: NCT02072681|
Recruitment Status : Active, not recruiting
First Posted : February 26, 2014
Last Update Posted : January 15, 2021
|Condition or disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||2650 participants|
|Target Follow-Up Duration:||3 Months|
|Official Title:||Mild and Rapidly Improving Stroke Study|
|Study Start Date :||March 2015|
|Actual Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||June 30, 2021|
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.
- Proportion of patients not independent at 90 days [ Time Frame: 90 days ]The primary outcome measure is proportion of patients with a modified Rankin Scale of 2-6 at 90 days
- Proportion of patients with dependence or disability in activities of daily living at 90 days [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 30 days ]Proportion of patients with modified Rankin Scale 2-6 at 30 days.
- Quality of life by the EuroQOL EQ-5D [ Time Frame: 90 days ]EuroQOL will be treated as a continuous measure
- Stroke disability by the Stroke-Impact Scale-16 [ Time Frame: 90 days ]SIS-16 will be treated as a continuous measure
- Independence with Activities of Daily Living by the Barthel Index [ Time Frame: 90 days ]BI will be treated as a continuous measure; pre specified analysis include proportion of patients with Barthel Index <95
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02072681
|Principal Investigator:||Jose G Romano, MD||University of Miami|