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Mild and Rapidly Improving Stroke Study

Mild and Rapidly Improving Stroke Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02072681
Acronym
MaRISS
Enrollment
2175
Registered
2014-02-26
Start date
2015-03-31
Completion date
2021-06-30
Last updated
2021-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

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

American Heart Association
CollaboratorOTHER
Genentech, Inc.
CollaboratorINDUSTRY
University of Miami
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

MeasureTime frameDescription
Proportion of patients not independent at 90 days90 daysThe primary outcome measure is proportion of patients with a modified Rankin Scale of 2-6 at 90 days

Secondary

MeasureTime frameDescription
Symptomatic intracranial hemorrhage due to Alteplase36 hoursAmongst 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 days30 daysProportion 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 days90 daysProportion of patients not independent in activities of daily living defined as a Barthel Index score \<95
Stroke disability by the Stroke-Impact Scale-1690 daysSIS-16 will be treated as a continuous measure
Independence with Activities of Daily Living by the Barthel Index90 daysBI 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-5D90 daysEuroQOL will be treated as a continuous measure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026