4922 Participants Needed

Post-Stroke Monitoring Strategies for Ischemic Stroke

Recruiting at 53 trial locations
VC
CA
Overseen ByCraig Anderson, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Craig Anderson
Must be taking: IV alteplase

Trial Summary

What is the purpose of this trial?

OPTIMISTmain is an investigator-initiated and conducted, international, multicentre, stepped wedge cluster randomized controlled trial comparing the effects of different intensities of nursing care monitoring for patients with acute ischemic stroke of mild severity and without critical care needs after IV-tPA.

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. Please consult with the trial coordinators for more details.

What data supports the idea that Post-Stroke Monitoring Strategies for Ischemic Stroke is an effective treatment?

The available research shows that effective management of ischemic stroke involves prompt assessment and monitoring of vital signs like blood pressure and oxygen levels. This helps in early detection of complications and improves patient outcomes. While the research highlights the importance of organized stroke services and early interventions like aspirin and intravenous treatments, it emphasizes that close monitoring is crucial to detect any early signs of deterioration. This supports the idea that Post-Stroke Monitoring Strategies are effective in managing ischemic stroke.12345

What safety data exists for post-stroke monitoring strategies for ischemic stroke?

The provided research does not directly address safety data for specific post-stroke monitoring strategies like 'Guideline recommended standard monitoring,' 'Low-intensity monitoring strategy,' or 'Optimal Post Tpa-Iv Monitoring.' However, the studies emphasize the importance of evidence-based guidelines for secondary prevention and management of ischemic stroke, including antiplatelet therapy and risk factor control. The Liverpool Heart And bRain Project (L-HARP) aims to investigate cardiovascular outcomes and risk factors post-stroke, which may indirectly contribute to understanding safety in monitoring strategies. Further specific studies would be needed to evaluate the safety of these particular monitoring strategies.678910

Is the treatment 'Guideline recommended standard monitoring' a promising treatment for post-stroke monitoring in ischemic stroke?

Yes, 'Guideline recommended standard monitoring' is a promising treatment for post-stroke monitoring in ischemic stroke. It helps in preventing future strokes by controlling risk factors and using appropriate therapies. This approach is based on expert recommendations and evidence, aiming to improve patient outcomes.711121314

Research Team

VC

Victor C Urrutia, MD

Principal Investigator

Johns Hopkins University

CS

Craig S Anderson, MD PhD

Principal Investigator

The George Institute

Eligibility Criteria

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.

Inclusion Criteria

I am 18 years old or older.
My neurological impairment is mild to moderate.
I have been treated with IV alteplase for a stroke.
See 1 more

Exclusion Criteria

You have a clear reason for not being able to undergo standard neurological monitoring.
I have a significant neurological condition.

Treatment Details

Interventions

  • Guideline recommended standard monitoring
  • Low-intensity monitoring strategy
Trial OverviewThe 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.
Participant Groups
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 Clinic Near You

Who Is Running the Clinical Trial?

Craig Anderson

Lead Sponsor

Trials
1
Recruited
4,900+

Johns Hopkins University

Collaborator

Trials
2,366
Recruited
15,160,000+

Genentech, Inc.

Industry Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

The George Institute for Global Health, Australia

Collaborator

Trials
20
Recruited
50,200+

Findings from Research

In a study of 114 patients with ischaemic stroke, brain edema occurred in 7.9% of cases, particularly affecting women, those with hypertension, elevated serum creatinine, and diabetes.
While brain edema did not significantly impact survival rates after acute ischaemic stroke, it was associated with a greater degree of neurological deficits at both admission and discharge.
Brain Edema After Ischaemic Stroke.Dostovic, Z., Dostovic, E., Smajlovic, D., et al.[2018]
Acute ischemic stroke, which makes up 80% of all strokes, is a major cause of death and disability, but management strategies have significantly improved over time.
Key advancements in treatment include the establishment of intensive care stroke units, acute recanalization techniques, and better management of post-stroke complications, all aimed at enhancing patient outcomes.
[Management of ischemic stroke in the acute phase].Duloquin, G., Graber, M., Baptiste, L., et al.[2022]
National audits in the UK highlight ongoing deficiencies in basic stroke care, emphasizing the need for prompt assessment and management of key physiological parameters like blood pressure and oxygenation.
Three critical interventions for acute ischaemic stroke—admission to a specialized stroke service, early administration of aspirin, and intravenous thrombolysis—are proven to improve patient outcomes, and implementing multidisciplinary guidelines can enhance overall care quality.
Management of acute ischaemic stroke.Jarrett, D., Hemang, D.[2011]

References

1.Bosnia and Herzegovinapubmed.ncbi.nlm.nih.gov
Brain Edema After Ischaemic Stroke. [2018]
[Management of ischemic stroke in the acute phase]. [2022]
Management of acute ischaemic stroke. [2011]
Early Management of Acute Ischaemic Stroke: A Clinical Perspective. [2021]
Stroke Performance Measures Do Not Predict Functional Outcome. [2020]
Protecting Patient Safety and Preventing Modifiable Complications After Acute Ischemic Stroke. [2020]
Guidelines for the prevention of stroke in patients with stroke and transient ischemic attack: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. [2022]
The Liverpool Heart And bRain Project (L-HARP): Protocol for an Observational Cohort Study of Cardiovascular Risk and Outcomes Following Stroke. [2022]
The role of antiplatelet therapy in the management of ischemic stroke: implementation of guidelines in current practice. [2008]
10.United Statespubmed.ncbi.nlm.nih.gov
Stroke: current concepts. [2014]
Expert opinion paper on atrial fibrillation detection after ischemic stroke. [2018]
12.United Statespubmed.ncbi.nlm.nih.gov
Clinical review and implications of the guideline for the early management of patients with acute ischemic stroke. [2014]
13.United Statespubmed.ncbi.nlm.nih.gov
Management of acute stroke. [2017]
The Importance of Platelets Response during Antiplatelet Treatment after Ischemic Stroke-Between Benefit and Risk: A Systematic Review. [2022]