Post-Stroke Monitoring Strategies for Ischemic Stroke

No longer recruiting at 56 trial locations

Overseen By Craig Anderson, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Craig Anderson

Must be taking: IV alteplase

Disqualifiers: Major neurological impairment, others

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods for monitoring patients after a mild stroke treated with a clot-busting drug called IV-tPA. Researchers aim to determine if less frequent monitoring is as effective as the standard approach for stable patients who do not require critical care. The trial includes two groups: one receives standard monitoring (guideline-recommended) and the other undergoes less intensive checks (low-intensity monitoring strategy). Suitable candidates have experienced a mild stroke treated with IV-tPA and remain stable without needing critical care. As an unphased trial, this study allows patients to contribute to research that could enhance post-stroke care strategies.

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 prior data suggests that these monitoring strategies are safe for post-stroke patients?

Research has shown that low-intensity monitoring is safe for patients who have had a mild stroke after receiving IV-tPA treatment. In these studies, patients underwent less frequent checks, with vital signs and neurological assessments conducted at specific intervals. This approach was well-tolerated and did not increase the risk of complications.

One study compared low-intensity monitoring to standard monitoring and found it to be equally safe. Patients had their heart rate, blood pressure, and neurological status checked regularly, though less frequently than with standard monitoring.

Overall, evidence suggests that low-intensity monitoring after a mild stroke is safe for patients. These studies reported no significant increases in unwanted effects. This method can be a safe choice for stroke patients at low risk for complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how different monitoring strategies after an ischemic stroke might impact recovery. Unlike standard care, which involves intensive monitoring in an ICU setting, the trial is comparing a low-intensity monitoring strategy in a non-ICU ward. This approach could potentially reduce the burden on healthcare resources while still ensuring patient safety. By evaluating these different methods, researchers hope to find a more efficient way to monitor stroke patients that could improve outcomes and reduce hospital stays.

What evidence suggests that these monitoring strategies are effective for post-stroke care?

Research has shown that monitoring patients less frequently after stroke treatment can be as safe and effective as regular monitoring. In this trial, participants will be assigned to either the guideline-recommended standard monitoring or the low-intensity monitoring strategy. The low-intensity approach involves checking vital signs and neurological status less often, potentially increasing patient comfort. Studies indicate that this method does not raise the risk of complications for patients who are not in critical condition. Early results suggest that low-intensity monitoring could be a reliable option for those recovering from mild strokes. These findings are based on comparisons with standard monitoring practices. ^{2 3 4 5 6}

Who Is on the Research Team?

Victor C Urrutia, MD

Principal Investigator

Johns Hopkins University

Craig S Anderson, MD PhD

Principal Investigator

The George Institute

Are You a Good Fit for This Trial?

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

My neurological impairment is mild to moderate.

I have been treated with IV alteplase for a stroke.

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

Exclusion Criteria

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

I have a significant neurological condition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Standard Care Monitoring

Participants receive guideline recommended standard monitoring with vital signs and neurological assessments

4 months

Continuous monitoring in hospital

Low-Intensity Monitoring

Participants receive low-intensity monitoring with less frequent vital signs and neurological assessments

4-9 months

Continuous monitoring in hospital

Follow-up

Participants are monitored for safety and effectiveness after treatment

90 days

1 visit (in-person) at 90 days

What Are the Treatments Tested in This Trial?

Interventions

• Guideline recommended standard monitoring
• Low-intensity monitoring strategy

Trial Overview 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.

How Is the Trial Designed?

Group I: Low-intensity monitoring strategy Active Control 1 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 monitoring Placebo Group 1 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

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

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

The George Institute for Global Health, Australia

Collaborator

Trials

20

Recruited

50,200+

Published Research Related to This Trial

Antiplatelet therapy can reduce the risk of subsequent strokes by 11-15% in patients with ischemic stroke or transient ischemic attack, but its effectiveness varies based on individual platelet reactivity.

Monitoring platelet function is crucial for optimizing antiplatelet therapy, as patients resistant to aspirin may benefit from dual antiplatelet therapy, highlighting the need for personalized treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Importance of Platelets Response during Antiplatelet Treatment after Ischemic Stroke-Between Benefit and Risk: A Systematic Review. Sikora, J., Karczmarska-Wódzka, A., Bugieda, J., et al.[2022]

Strokes are classified into ischemic (80-87%) and hemorrhagic (13-20%), with ischemic strokes being caused by blood clots or reduced blood flow, highlighting the importance of rapid assessment and treatment to maximize brain tissue reperfusion.

Effective stroke management focuses on stabilizing the patient and may include thrombolytics if appropriate, while prevention strategies emphasize controlling cardiovascular risk factors and using antiplatelet therapy to reduce the risk of first-time or recurrent strokes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stroke: current concepts. Albertson, M., Sharma, J.[2014]

The updated guideline provides evidence-based recommendations for preventing future strokes in survivors of ischemic stroke or transient ischemic attack, focusing on managing risk factors and specific interventions.

It includes tailored recommendations for various conditions that increase stroke risk, such as aortic arch atherosclerosis and antiphospholipid antibody syndrome, ensuring comprehensive care for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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. Kernan, WN., Ovbiagele, B., Black, HR., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Management of ischemic stroke in the acute phase]. Duloquin, G., Graber, M., Baptiste, L., et al.[2022]

The updated guidelines from the American Heart Association/American Stroke Association include 115 recommendations for the early management of acute ischemic stroke, which are crucial for improving patient outcomes.

Among these, there are 24 new and 51 revised recommendations that provide evidence-based strategies for clinicians to recognize and treat ischemic stroke effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical review and implications of the guideline for the early management of patients with acute ischemic stroke. Livesay, SL.[2014]

Timely intervention in acute ischaemic stroke is crucial, as the severity of brain injury worsens rapidly in the first few hours, making early stabilization and reperfusion essential.

The main treatment options for restoring blood flow are intravenous tissue plasminogen activator (IV tPA) and endovascular thrombectomy (EVT), both of which require careful monitoring for potential complications during and after the procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Management of Acute Ischaemic Stroke: A Clinical Perspective. Morawo, AO., Adams, CA.[2021]

In a study of 565 ischemic stroke patients, adherence to current stroke performance measures did not show a significant association with better functional outcomes 90 days post-stroke, as measured by activities of daily living scores.

Despite 58.4% of patients receiving defect-free care and a high median opportunity score, these factors did not correlate with improved recovery, suggesting a need for the development of more effective performance measures for stroke care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stroke Performance Measures Do Not Predict Functional Outcome. Adelman, EE., Lisabeth, LD., Smith, MA., et al.[2020]

Acute ischemic stroke can lead to various complications that significantly impact patient safety, including risks of falls, malnutrition, and infections, highlighting the need for tailored care plans.

Understanding the physiological changes after a stroke allows nurses to implement specific interventions that can enhance patient safety and reduce the likelihood of further complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Protecting Patient Safety and Preventing Modifiable Complications After Acute Ischemic Stroke. Tamburri, LM., Hollender, KD., Orzano, D.[2020]

This study aims to investigate cardiovascular outcomes and risk factors in a cohort of 1222 adult patients who have experienced an ischaemic stroke or transient ischaemic attack, with a follow-up period of 12 months.

The research will refine and validate risk prediction models for adverse cardiovascular events, including atrial fibrillation and cognitive impairment, using both routinely collected data and participant questionnaires.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Liverpool Heart And bRain Project (L-HARP): Protocol for an Observational Cohort Study of Cardiovascular Risk and Outcomes Following Stroke. Harrison, SL., Lane, DA., Buckley, BJR., et al.[2022]

Antiplatelet therapy, particularly with agents like clopidogrel and the combination of aspirin plus dipyridamole, is highly effective for secondary prevention of recurrent vascular events in patients with ischemic stroke or TIA, and is preferred over oral anticoagulants for non-cardioembolic strokes.

Despite strong evidence-based guidelines supporting the use of these therapies, their implementation remains low, highlighting the need for quality improvement initiatives to enhance adherence and improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of antiplatelet therapy in the management of ischemic stroke: implementation of guidelines in current practice. Biller, J.[2008]

Detecting atrial fibrillation in patients who have had an ischemic stroke is crucial because it can lead to better secondary stroke prevention through the use of oral anticoagulants, which are more effective than antiplatelet drugs.

The paper proposes a structured approach for ECG monitoring in stroke units to improve the detection of atrial fibrillation, although the optimal duration and method of monitoring are still being determined.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Expert opinion paper on atrial fibrillation detection after ischemic stroke. Haeusler, KG., Gröschel, K., Köhrmann, M., et al.[2018]

Timely recognition and treatment of acute ischemic stroke is crucial, with intravenous tissue plasminogen activator (t-PA) being the primary treatment for eligible patients, while those who do not qualify should receive aspirin therapy.

All stroke patients should receive supportive care, including hydration, correction of hypoxia, and management of hyperglycemia and fever, with individualized blood pressure management based on their specific condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of acute stroke. Zweifler, RM.[2017]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of acute ischaemic stroke. Jarrett, D., Hemang, D.[2011]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03734640

Optimal Post Tpa-Iv Monitoring in Ischemic Stroke Consent/randomization: Hospitals will be eligible if they are using the proposed low-intensity nursing monitoring strategy. A stepped-wedge cluster randomized ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37883934/

The main Optimal Post rTpa-Iv Monitoring in Ischemic ... Compared to standard monitoring, the low-intensity monitoring protocol includes assessments of neurological and vital signs every 15 min for 2 h, 2 hourly (vs.

3. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)00549-5/abstract

Safety and efficacy of low-intensity versus standard ... The low-intensity monitoring protocol included assessments of neurological and vital signs every 15 min for 2 h, every 2 h for 8 h (vs every 30 ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6900650/

Safety Trial of Low-Intensity Monitoring After Thrombolysis The present study sought to prospectively evaluate whether post-IVT stroke patients with low risk for complications may safely be cared for utilizing a novel ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673625005495

Articles Safety and efficacy of low-intensity versus standard ... The low-intensity monitoring protocol included assessments of neurological and vital signs every 15 min for 2 h, every 2 h for 8 h (vs every 30 min for 6 h for ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/31839859/

Optimal Post Tpa-Iv Monitoring in Ischemic STroke (OPTIMIST) Conclusion: Post-IVT stroke patients may be safely monitored in the setting of a low-intensity protocol. Keywords: critical care needs; low-intensity monitoring ...