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Post-Stroke Monitoring Strategies for Ischemic Stroke

N/A

Recruiting

Led By Victor C Urrutia, MD

Research Sponsored by Craig Anderson

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have a mild-moderate level of neurological impairment (e.g. score <10 on the NIHSS)

Have received IV alteplase for AIS according to standard criteria

Must not have

Major neurological impairment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 90

Summary

This trial is comparing the effects of different intensities of nursing care monitoring for patients with acute ischemic stroke of mild severity.

Who is the study for?

This trial is for adults over 18 who've had a mild to moderate ischemic stroke and received IV alteplase treatment. They should be stable without needing intensive care after the infusion. It's not for those with major neurological issues or specific reasons they can't have standard or low-intensity monitoring.

What is being tested?

The OPTIMISTmain study compares two ways of watching over stroke patients after they get tPA-IV: the usual way recommended by guidelines versus a less intense method. This research involves multiple hospitals and randomly assigns them to change their monitoring approach at different times.

What are the potential side effects?

Since this trial compares different levels of nursing care rather than medications, there are no direct side effects from treatments being tested. However, differences in monitoring could potentially impact how well complications are detected and managed.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My neurological impairment is mild to moderate.

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I have been treated with IV alteplase for a stroke.

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I was stable and didn't need intensive care after my alteplase infusion.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a significant neurological condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 90

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 90

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 90 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

modified Rankin scale (mRS); shift analysis across full range of scores

Secondary study objectives

Measures of hospital costs

frequency of major Symptomatic intracerebral hemorrhage

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Low-intensity monitoring strategyActive Control1 Intervention

vital signs (HR, BP) and neurological assessment (GCS and/or NIHSS) 15-30mins x 2 hours, 2hourly x 8 hours, 4hourly x 14 hours in a non-ICU ward

Group II: Guideline recommended standard monitoringPlacebo Group1 Intervention

vital signs (HR, BP) and neurological assessment (GCS and NIHSS) 15-30mins x 2 hours, 30mins x 6 hours, 1hourly x 16 hours in usual care monitoring environment

0 / 4Eligibility criteria met