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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
Awards & highlights

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
Select...
My neurological impairment is mild to moderate.
Select...
I have been treated with IV alteplase for a stroke.
Select...
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:
Select...
I have a significant neurological condition.

Timeline

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

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityOTHER
2,307 Previous Clinical Trials
14,854,709 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,550 Previous Clinical Trials
561,164 Total Patients Enrolled
The George Institute for Global Health, AustraliaOTHER
19 Previous Clinical Trials
45,256 Total Patients Enrolled

Media Library

Guideline recommended standard monitoring Clinical Trial Eligibility Overview. Trial Name: NCT03734640 — N/A
Acute Ischemic Stroke Therapy Research Study Groups: Guideline recommended standard monitoring, Low-intensity monitoring strategy
Acute Ischemic Stroke Therapy Clinical Trial 2023: Guideline recommended standard monitoring Highlights & Side Effects. Trial Name: NCT03734640 — N/A
Guideline recommended standard monitoring 2023 Treatment Timeline for Medical Study. Trial Name: NCT03734640 — N/A
~171 spots leftby Nov 2024
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