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.
12345What 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.
678910Is 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.
711121314Eligibility 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.
+1 more
Exclusion Criteria
You have a clear reason for not being able to undergo standard neurological monitoring.
I have a significant neurological condition.
Participant Groups
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.
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
Research Locations NearbySelect from list below to view details:
University of Rochester Medical CenterRochester, NY
ThedaCare Regional Medical Center AppletonAppleton, WI
Centura Littleton Adventist HospitalLittleton, CO
Centura St. Anthony HospitalLakewood, CO
More Trial Locations
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Who Is Running the Clinical Trial?
Craig AndersonLead Sponsor
Johns Hopkins UniversityCollaborator
Genentech, Inc.Industry Sponsor
The George Institute for Global Health, AustraliaCollaborator
References
Brain Edema After Ischaemic Stroke. [2018]To determine the incidence of brain edema after ischaemic stroke and its impact on the outcome of patients in the acute phase of ischaemic stroke.
[Management of ischemic stroke in the acute phase]. [2022]Ischemic stroke accounts for 80% of overall stroke, and is one of the leading causes of death, disability and dementia in worldwide. Management of patients with acute ischemic stroke dramatically improved over time with the implementation of intensive care stroke units, the development of acute recanalization strategies, the optimization of the management of post-stroke complications, and the prevention of early stroke recurrence. The objective of this article is to provide a general overview of the current management of patients with acute ischemic stroke aiming at improving post-stroke outcome.
Management of acute ischaemic stroke. [2011]National audits of stroke care in the UK have repeatedly shown deficiencies in basic care. The key to good care is prompt thorough assessment, investigation and management of physiological parameters i.e blood pressure, glycaemia, temperature and oxygenation. Three interventions are of proven benefit in acute ischaemic stroke: admission to an organised stroke service, early aspirin and intravenous thrombolysis. The use of multidisciplinary guidelines and education and audit around these improves care.
Early Management of Acute Ischaemic Stroke: A Clinical Perspective. [2021]Stroke is a leading cause of disability and mortality globally. In the first few hours after ischaemic stroke, the severity and irreversibility of brain injury increase as time passes. The primary goal of the emergent management of acute ischaemic stroke is stabilization and reperfusion of the ischaemic penumbra if eligibility criteria are met and contraindications are ruled out. The primary reperfusion strategies are administration of intravenous tissue plasminogen activator (IV tPA) and endovascular thrombectomy (EVT). Close monitoring is warranted prior to, during, and after these reperfusion procedures to detect early neurologic deterioration that may signify complications from treatment.
Stroke Performance Measures Do Not Predict Functional Outcome. [2020]Poststroke functional outcome is critical to stroke survivors. We sought to determine whether adherence to current stroke performance measures is associated with better functional outcome 90 days after an ischemic stroke.
Protecting Patient Safety and Preventing Modifiable Complications After Acute Ischemic Stroke. [2020]Protecting patient safety and preventing modifiable complications after acute ischemic stroke.
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 aim of this updated guideline is to provide comprehensive and timely evidence-based recommendations on the prevention of future stroke among survivors of ischemic stroke or transient ischemic attack. The guideline is addressed to all clinicians who manage secondary prevention for these patients. Evidence-based recommendations are provided for control of risk factors, intervention for vascular obstruction, antithrombotic therapy for cardioembolism, and antiplatelet therapy for noncardioembolic stroke. Recommendations are also provided for the prevention of recurrent stroke in a variety of specific circumstances, including aortic arch atherosclerosis, arterial dissection, patent foramen ovale, hyperhomocysteinemia, hypercoagulable states, antiphospholipid antibody syndrome, sickle cell disease, cerebral venous sinus thrombosis, and pregnancy. Special sections address use of antithrombotic and anticoagulation therapy after an intracranial hemorrhage and implementation of guidelines.
The Liverpool Heart And bRain Project (L-HARP): Protocol for an Observational Cohort Study of Cardiovascular Risk and Outcomes Following Stroke. [2022]Further research is needed to refine risk prediction models for adverse cardiovascular outcomes following stroke in contemporary clinical practice, such as incident atrial fibrillation (AF), recurrent stroke, and cognitive impairment and dementia. The aims of this study are to prospectively investigate cardiovascular outcomes and risk factors for incident cardiovascular disease in a post-stroke cohort, and to externally validate, refine and expand current risk prediction models for cardiovascular and cardiovascular-related outcomes. The study sample size was based on the development of post-stroke risk prediction models for AF and was calculated as 1222 participants. The study design is a multicentre, prospective, observational cohort study. Participants will be adult patients admitted for ischaemic stroke confirmed by stroke physician or transient ischaemic attack (TIA) confirmed by MRI. Routinely collected data will be used in addition to the completion of simple validated questionnaires by the participants. Follow-up will be undertaken 12-months from the date of admission to hospital, in addition to linkage to routinely collected follow-up hospitalisation and mortality data. The primary outcomes are cardiovascular outcomes (including incident AF, stroke, TIA and myocardial infarction) at 12-month follow-up, all-cause mortality and mortality from cardiovascular causes, and incident cognitive impairment and dementia. Secondary outcomes include changes in function, depression, anxiety, fatigue and quality of life. The study has received approval from the Health Research Authority Research Ethics Committee (21/WA/0209), and is registered on https://www.clinicaltrials.gov/ (Identifier NCT05132465). Recruitment for the study began in October 2021 with completion of recruitment at all participating centres anticipated by October 2022.
The role of antiplatelet therapy in the management of ischemic stroke: implementation of guidelines in current practice. [2008]To review and discuss evidence-based guideline recommendations for the use of antiplatelet agents for secondary prevention in patients with ischemic stroke or TIA.
Stroke: current concepts. [2014]Cerebrovascular accidents (CVAs) are the leading cause of disability and the fourth leading cause of death in the U.S. The WHO defines stroke as "rapidly developing clinical signs of focal disturbance of cerebral function lasting more than 24 hours with no apparent cause other than of vascular origin." Strokes are subdivided into two major classifications: ischemic (80-87 percent) andhemorrhagic (13-20 percent). Ischemic strokes occur from thrombi, emboli, or global hypoperfusion. Hemorrhagic strokes are either parenchymal (10 percent of all strokes) or subarachnoid (3 percent of all strokes). There are a variety of recognized risk factors for stroke which include: age, race, family history, hypertension, diabetes mellitus, atherosclerosis, cardiac arrhythmias, prosthetic valves, hyperlipidemia, cigarette smoking, and others (drugs or hormones). The initial assessment of a patient suspected of stroke should be done quickly enough to ensure maximal reperfusion of brain tissue. The steps to achieve this goal are: 1) exclude an intracranial hemorrhage, 2) assess for contraindications to thrombolytics, 3) characterize the infarct. The workup for a patient should first include a history (especially the time when neurologic symptoms began), a physical exam (including the NIHSS), and imaging studies (to rule out hemorrhagic components). In addition, several lab studies can also be obtained including: PT/INR, glucose, complete blood count, metabolic panel, creatine kinase, ECG, echocardiogram, lipid panel, carotid Doppler, MRA or CTA. Acute management of a stroke is primarily focused on stabilizing the patient and allowing as much reperfusion as possible for at-risk brain tissue. Stroke management in the acute setting includes: use of thrombolytics if indicated, and re-assessment to monitor progression. Several trials have been completed in pursuit of safety and effectiveness of intra-arterial stroke therapy for patients outside the recommended thrombolytic time window, but so far they are only experimental treatment options. The best preventative measures for first time or recurrent stroke are: starting or switching antiplatelet therapy, treatment of cardiovascular risk factors (atrial fibrillation and carotid stenosis), optimization of hypertension, dyslipidemia and diabetes mellitus management, and smoking cessation.
Expert opinion paper on atrial fibrillation detection after ischemic stroke. [2018]This expert opinion paper on atrial fibrillation detection after ischemic stroke includes a statement of the "Heart and Brain" consortium of the German Cardiac Society and the German Stroke Society. This paper was endorsed by the Stroke Unit-Commission of the German Stroke Society and the German Atrial Fibrillation NETwork. In patients with ischemic stroke, detection of atrial fibrillation should usually lead to a change in secondary stroke prevention, since oral anticoagulation is superior to antiplatelet drugs. The detection of previously undiagnosed atrial fibrillation can be improved in patients with ischemic stroke to optimize stroke prevention. This paper summarizes the present knowledge on atrial fibrillation detection after ischemic stroke. We propose an interdisciplinary standard for a "structured analysis of ECG monitoring" on the stroke unit as well as a staged diagnostic scheme for the detection of atrial fibrillation. Since the optimal duration and mode of ECG monitoring has not yet been finally established, this paper is intended to give advice to physicians who are involved in stroke care. In line with the nature of an expert opinion paper, labeling of classes of recommendations is not provided, since many statements are based on the expert opinion, reported case series and clinical experience. Therefore, this paper is not intended as a guideline.
Clinical review and implications of the guideline for the early management of patients with acute ischemic stroke. [2014]Stroke is the fourth leading cause of death and the leading cause of significant, long-term disability in the United States. Clinicians' knowledge and use of evidence to guide the care of patients with ischemic stroke are paramount to improving patient outcomes. The recently updated "Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association" provides clinicians with evidence-based, expert consensus to guide the recognition and early management of patients with acute ischemic stroke. The guideline provides 115 recommendations for the management of patients with acute ischemic stroke, including 24 new recommendations and 51 revised recommendations divided into 14 major topic areas. This article reviews the recommendations and related literature and provides suggestions for use and implementation of the guideline within a stroke program of care.
Management of acute stroke. [2017]Stroke ranks as the third leading cause of death and the most common cause of permanent disability in adults. Timely recognition and treatment is imperative to reduce stroke-related morbidity and mortality. Patients with acute ischemic stroke should be evaluated for administration of intravenous tissue plasminogen activator (t-PA); those who do not qualify for t-PA should receive aspirin therapy in the absence of a contraindication. In all stroke patients, intravenous hydration with normal saline should be administered, hypoxia should be corrected with supplemental oxygen, and hyperglycemia and fever should be treated aggressively. Blood pressure management should be individualized on the basis of stroke pathophysiology and specific treatment plan (e.g., planned thrombolysis) following published guidelines. Evaluation of stroke etiology should be undertaken, and the results should be used to guide secondary stroke prevention efforts.
The Importance of Platelets Response during Antiplatelet Treatment after Ischemic Stroke-Between Benefit and Risk: A Systematic Review. [2022]Ischemic stroke is a disease related to abnormal blood flow that leads to brain dysfunction. The early and late phases of the disease are distinguished. A distinction is made between the early and late stages of the disease, and the best effect in treating an ischemic stroke is usually achieved within the first hours after the onset of symptoms. This review looked at studies platelet activity monitoring studies to determine the risks and benefits of various approaches including antiplatelet therapy. A study was conducted on recently published literature based on PRISMA. This review includes 32 research articles directly addressing the importance of monitoring platelet function during antiplatelet therapy (dual or monotherapy) after ischemic stroke. In patients with transient ischemic attack or ischemic stroke, antiplatelet therapy can reduce the risk of stroke by 11-15%, assuming that patients respond well. Secondary prevention results are dependent on platelet reactivity, meaning that patients do not respond equally to antiplatelet therapy. It is very important that aspirin-resistant patients can benefit from the use of dual antiplatelet therapy. The individualized approach to secondary stroke prevention is to administer the most appropriate drug at the correct dose and apply the optimal therapeutic procedure to the individual patient.