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Post-Stroke Monitoring Strategies for Ischemic Stroke

Q: Are there any subjects required for this experiment that are not currently enrolled?

<p>Indeed, the online information regarding this study indicates that it is still recruiting patients. This trial was initially posted on April 28th, 2021 and was most recently updated on August 1st, 2022. The research is looking for 7200 individuals from 19 different locations.</p>

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 90

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Select...

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Measures of hospital costs

any serious adverse event during follow-up

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 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Johns Hopkins UniversityOTHER

2,263 Previous Clinical Trials

14,815,965 Total Patients Enrolled

Genentech, Inc.Industry Sponsor

1,541 Previous Clinical Trials

560,943 Total Patients Enrolled

The George Institute for Global Health, AustraliaOTHER

18 Previous Clinical Trials

41,980 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any subjects required for this experiment that are not currently enrolled?

"Indeed, the online information regarding this study indicates that it is still recruiting patients. This trial was initially posted on April 28th, 2021 and was most recently updated on August 1st, 2022. The research is looking for 7200 individuals from 19 different locations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Optimal Post Tpa-Iv Monitoring in Ischemic Stroke

Craig Anderson 2021. "Optimal Post Tpa-Iv Monitoring in Ischemic Stroke". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03734640.

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