Clinical Trials

The purpose of this study is to determine whether the application of compression to the distal aspect of the upper extremity of a person with stroke will increase range of motion of the wrist.

The purpose of this study is to test the feasibility of providing a mindfulness based stress management intervention, the Resilient Living Program,to stroke survivors and their family caregivers. The Resilient Living Program consists of an introduction and 4 online modules, each completed  2 weeks apart. Stroke survivors and their caregivers will practice the strategies taught in the modules using a journal to record. Questionnaires to gauge the impact of the intervention will be completed at baseline, 5, 9, and 12 weeks.

The Stroke Hyperglycemia Insulin Network Effort (SHINE) Trial is a multicenter, randomized, controlled clinical trial of 1400 patients that will include approximately 60 enrolling sites. The study hypotheses are that treatment of hyperglycemic acute ischemic stroke patients with targeted glucose concentration (80mg/dL - 130 mg/dL) will be safe and result in improved 3 month outcome after stroke. Eligible subjects must be within 12 hours of stroke symptom onset and have diabetes and glucose concentrations of over 110 mg/dL on initial evaluation. The enrolling sites will include the Neurological Emergencies Treatment Trials (NETT) sites as well as non NETT sites from ...

The purpose of this study is to develop a computer vision based software program to better understand upper extremity movements after stroke.

The purpose of this study is to assess the effectiveness of the Better Mobile Health App for use by patients after hospital discharge for a stroke by using satisfaction survey ratings and hospital readmission rates. The Better App provides a personal health assistant who assists in coordination of care. The app is provided in addition to standard care and compared to the use of standard care alone.

The purpose of this pilot study is to examine the feasibility of methods to assess and describe the presence of symptoms and their characteristics in young adult stroke survivors.  

The purpose of this study is comparing physician empathy, as perceived by the patient, during acute stroke consultation among patients seen remotely by telemedicine consult to those who received an in-person consult.

Stroke is the second leading cause of death worldwide. Traditional stroke risk factors explain about half of the risk for stroke. The remaining half may be partially explained by sleep duration and disturbances, which are prospectively related to incident stroke across multiple populations. Although these relationships have been identified, at present, essentially nothing is known regarding the modifiable, sleep-inhibiting behaviors that determine sleep duration and disruption; these are probable targets of stroke prevention. The study proposed here is intended to fill this void by determining the relation between sleep-inhibiting behaviors, self-reported sleep duration and disruption, and stroke amongst acute stroke ...

The purpose of this study is to assess if patient outcomes are improved when the Comprehensive Stroke Center/Primary Stroke Center (CSC/PSC) system is supplemented with an Integrated Stroke Practice Unit (ISPU) system of care, a patient-centric model of care involving the patient and caregiver/family that coordinates care from the acute management through the rehabilitation and recovery of the patient.

This is a randomized, double-blind, placebo-controlled parallel group outpatient study that will utilize standard stroke rehabilitation outcome measures, as well as fMRI techniques in a subset of subjects, to evaluate the effect of HT-3951 on motor recovery and behavior in medically stable subjects following ischemic stroke.

The purpose of this study is to to explain the mechanisms of brain resilience and susceptibility to post-stroke cognitive impairment and dementia (PSCID) in diverse U.S. populations based on the complex interplay among vascular risk factors, pre-existing disease burden, acute stroke lesion location, and genomic and epigenomic variations.

For stroke, interval times, such as door-to-imaging (DTI), door-to-needle (DTN), door-to-groin puncture (DTG), and door-to-reperfusion (DTR) times, are used to evaluate workflow efficiency. We hypothesize that by introducing case review feedback forms for each treated stroke case at our institution, individual members of the stroke team will develop a better estimation of their personal treatment times, and this will lead to an overall reduction in interval times after one year.

The purpose of this registry is to assess outcomes associated with the use of devices intended to restore blood flow in patients experiencing acute ischemic stroke.

The primary objectives of this study are to determine whether treatment of OSA with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

The purpose of this study is to determine whether a wristband that detects your pulse can detect your heart rate and rhythm similar to electrocardiograms (ECG).

This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

The purpose of this study is to assess the safety, performance and effectiveness of thrombus removal in subjects presenting with acute ischemic stroke with the NeVa stent retrievers.

The purposes of this study are to investigate the level of correspondence between the most severe and most bothersome symptoms, and to examine discordant responses to determine which symptoms are reported as the most bothersome despite not being the most severe. A secondary aim is to examine the relationship between specific symptoms and time since stroke.

The purpose of this study is to find out what kinds of therapy equipment are most effective in improving walking and balance after a stroke.

The primary purpose of this study is to report the composite endpoint of survival to transplant, recovery, or LVAD support free of debilitating stroke (Modified Rankin Score > 3) or reoperation to replace the pump at 5-years post-implant in subjects who were implanted with the HM3 or HMII LVAS in the MOMENTUM 3 IDE trial and are ongoing at the 2-year follow-up.

The purpose of this study is to assess whether a novel therapy approach (repetitive facilitative exercise (RFE)) is more effective than conventional rehabilitation in facilitating the recovery of upper extremity function following stroke.

The purpose of this study is to evaluate a tele-rehabilitation service directed at treating upper limb weakness due to stroke to see if it is feasible to provide at Mayo Clinic, and also to assess if the stroke patients and clinicians are satisfied with the process.

The aims of this study are to assess the feasibility of and satisfaction with providing a tele-rehabilitation service directed at language disorders in individuals with stroke and measure the change in language function.

This is a study to evaluate the hypothesis that FDA cleared thrombectomy devices plus medical management leads to superior clinical outcomes in acute ischemic stroke patients at 90 days when compared to medical management alone in appropriately selected subjects with the Target mismatch profile and an MCA (M1 segment) or ICA occlusion who can be randomized and have endovascular treatment initiated between 6-16 hours after last seen well.

This is a pivotal phase study of up to 120 subjects and 15 clinical sites. All subjects are implanted with the Vivistim System® and then randomized to either study treatment or active-control treatment. The randomization will be stratified by age (<30, >30) and baseline FMA UE (20 to <35; >35 to 50). Study treatment is vagus nerve stimulation (VNS) delivered during rehabilitation. Active control treatment is rehabilitation (standard-of-care treatment) with only a minimal amount of VNS at the start of each session intended to support blinding.

This is a randomized, placebo-controlled, phase 3 clinical trial to evaluate the efficacy and safety of transcranial ultrasound (US) as an adjunctive therapy to tissue plasminogen activator (tPA) treatment in subjects with acute ischemic stroke.

The primary purpose of this study is to monitor patients with acute ischemic strokes who receive reperfusion therapies (tissue plasminogen activator, mechanical thrombectomy or both) with non-invasive cerebral oximetry to (rScO2) assess if changes in rScO2 can predict  changes in clinical neurologic examination.

The objective of this project is to evaluate a treatment decision aid for patients with atrial fibrillation.

VICTORY AF is an IDE, prospective global, multi-center, single arm, controlled, unblinded, investigational clinical study. The purpose of this clinical study is to evaluate the risk of procedure and/or device related strokes in subjects with persistent or long-standing persistent atrial fibrillation (AF) undergoing ablation with the Phased RF System.

A pivotal, prospective, multi-center, randomized, controlled, double-blinded study combining active Nexstim NBS-guided 1Hz rTMS or sham-rTMS targeting the healthy hemisphere with standardized task oriented rehabilitation will be conducted in patients with post-stroke motor impairment. The therapy will be provided for 6 weeks and primary outcome assessed 6 months later.

This is a prospective, randomized, controlled, unblinded, multi-center evaluation of the stroke incidence in patients implanted with a HeartWare HVAD who receive optimal blood pressure management. The study compares results of stroke incidence in a new cohort of subjects receiving optimal blood pressure management to a reference stroke incidence observed in the original IDE clinical trial (HW004) that did not specify optimal blood pressure management. In addition, a secondary endpoint will evaluate non-inferiority of stroke-free success on the originally implanted device to a control group (i.e. any FDA-approved LVAD for destination therapy). Subjects will be randomized to HeartWare HVAD or ...

The purpose of this study is to determine if cerebral perfusion imaging can identify a subset of patients who are most likely to have a favorable outcome after thrombectomy treatment. We hypothesize that patients with a favorable Critical Area Perfusion Score (CAPS≤3) on cerebral perfusion imaging will have a favorable response to revascularization by thrombectomy and that patients with a CAPS>3 will not.

The specific aims of this study are to:

1. Definitively determine the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of patients with death and disability (mRS 4-6) at 3 months among subjects with ICH who are treated within 4.5 hours of symptom onset.
2. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the subjects' quality of life as measured by EuroQol at 3 months.
3. Evaluate the therapeutic benefit of the intensive treatment relative to the standard treatment in the proportion of hematoma expansion (defined as increase from baseline hematoma volume of > ...

The purpose of this study is to examine the gait in patients with hemiplegia following a stroke, when wearing an ankle foot orthosis and without wearing an ankle foot orthosis.

The purpose of this study is to compare edoxaban (investigational drug) with warfarin and enoxaparin, to see if it is safe and effective in preventing stroke and other blood clot complications in subjects with atrial fibrillation whose doctors plan to treat them with an electrical cardioversion. It is expected that 284 sites will recruit 2200 subjects from North America, EU, Russia, Ukraine and Israel. Participants will be randomly allocated to receive either treatment with edoxaban, or treatment with warfarin, plus enoxaparin if required. Participants will have an equal chance of receiving either treatment. Participants will be in the study for ...

The objective of this study is to determine the mechanisms of stroke in patients with Intracranial Atherosclerotic Disease (IAD) by specifically evaluating limitations of antegrade flow through the stenotic artery, distal tissue perfusion to the affected territory, and artery-to-artery embolism. The hypothesis is that non-invasive imaging biomarkers that stratify stroke risk and distinguish mechanisms of IAD. This prospective multicenter study will enroll 175 patients with recently symptomatic high-grade IAD. Patients will be studied within 21 days of the index event (allowing appropriate time to arrange for diverse imaging modalities), with the following advanced neuroimaging techniques to elucidate mechanisms of recurrent ...

The purpose of this observational study is to describe how the human endocannabinoid system (ECS) responds to an ischemic stroke or transient ischemic attack and explore whether modulation of the ECS holds potential to serve as a therapeutic target for neuroprotective therapies.     

The purpose of this study is to screen high-risk subjects with annual prolonged cardiac monitoring to determine the rate of subclinical atrial fibrillation detection.
 

Objectives - Primary: To test the hypothesis that apixaban is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy. - Secondary: To test the hypothesis that the relative efficacy of apixaban over aspirin increases with the severity of atrial cardiopathy.

The purpose of this study is to compare the post-procedure treatment differences in stroke risk between those randomized to revascularization and intensive medical management (IMM) and those randomized to IMM alone.

The purpose of this research study is to examine how certain genes and lifetime and ongoing stress may impact rehabilitation and recovery after stroke.

The purpose of this study is to describe in detail the smoking history in a population of acute or prior cerebrovasculqar accident (CVA) patients and identify those who qualify for lung cancer screening by criteria outlined by three separate organizations.

Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.

We aim to determine whether cognitive impairment attributable to cerebral hemodynamic impairment in patients with high-grade asymptomatic carotid artery stenosis is reversible with restoration of flow. To accomplish this aim CREST-H will add on to the NINDS-sponsored CREST-2 trial (parallel, outcome-blinded Phase 3 clinical trials for patients with asymptomatic high-grade carotid artery stenosis which will compare carotid endarterectomy plus intensive medical management (IMM) versus IMM alone (n=1,240), and carotid artery stenting plus IMM versus IMM alone (n=1,240) to prevent stroke and death). CREST-H addresses the intriguing question of whether cognitive impairment can be reversed when it arises from abnormal cerebral ...

The primary purpose of this study is to test the theory that Eliquis (apixaban) is superior to aspirin for the prevention of recurrent stroke in patients with cryptogenic ischemic stroke and atrial cardiopathy.

The purpose of this study is to determine if an atrial fibillation (AF) detection intervention in men and women at least 70 years of age with undiagnosed AF or atrial flutter (AFL) reduces the person-years incidence rate of stroke compared to usual care (no AF detection intervention).

The overall goal of this study is to develop mesenchymal stem cell therapy for treatment of acute spontaneous hemorrhagic stroke.

A transient ischemic attack (TIA) is a transient episode of neurological dysfunction caused by focal brain, spinal cord, or retinal ischemia, without acute infarction. An ischemic stroke is a cerebral infarction. In POINT, eligibility is limited to brain TIAs and to minor ischemic strokes (with an NIH Stroke Scale [NIHSS] score less than or equal to 3).

TIAs are common, and are often harbingers of disabling strokes. Approximately 250,000-350,000 TIAs are diagnosed each year in the US. Given median survival of more than 8 years, there are approximately 2.4 million TIA survivors. In a national survey, one in fifteen of those ...

The purpose of this study is to engage Wisconsin's community hospitals statewide to identify the regional pre-hospital, hospital and community barriers to timely acute ischemic stroke therapy.

The purpose of this study is to provide clinical evidence of functional improvement, safety, and economic benefit when comparing intracerebral hemorrhage (ICH) evacuation surgery to medical treatment.

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The objective of this trial is to evaluate the effectiveness of left atrial appendage exclusion (LAAE) for the prevention of ischemic stroke or systemic arterial embolism in subjects undergoing cardiac surgery who have risk factors for atrial fibrillation and ischemic stroke.

The purpose of this study is to assess the effectiveness of Clopidogrel for preventing the occurance of transient ischemic attacks (TIA) and minor strokes.

1. The primary purpose of this study is to assess the comparative effectiveness of the following 4 approaches to promote high-quality SDM for at-risk patients with AF:  a PDA alone, (2) an EDA alone, (3) a combination of a PDA and an EDA, and (4) control with neither a PDA nor an EDA.

The purpose of this trial is to identify cancer survivors who are at increased risk of developing late-occurring complications after undergoing treatment for childhood cancer. A patient's genes may affect the risk of developing complications, such as congestive heart failure, heart attack, stroke, and second cancer, years after undergoing cancer treatment. Genetic studies may help doctors identify survivors of childhood cancer who are more likely to develop late complications.

The purpose of this study is to assist patients and clinicians weigh the potential harms and benefits of different treatment options for atrial fibrillation.  The plan is to develop an evidence-based decision aid for use in clinical encounters. The goal is to promote evidence-based patient-centered care. Ideally, this care should reflect the research evidence about treatment options for atrial fibrillation. It should also reflect the values and preferences of the informed patient.

The primary objective of the study is to demonstrate that anticoagulation with bivalirudin results in fewer major bleeding complications compared with unfractionated heparin (UFH) in subjects undergoing peripheral endovascular interventions (PEI). The secondary objective is to identify potential benefits from bivalirudin therapy on other clinically important events such as death, myocardial infarction (MI), stroke and/or transient ischemic attack (TIA), amputation, unplanned repeat revascularization (URV), and minor bleeding, as well as potential economic benefits that may result from improved clinical outcomes.

The purpose of this study is to evaluate the use of a smartphone app for stroke patients with obstructive sleep apnea in order to better use their positive airway pressure (PAP) therapy.

The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor (180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300 mg [three 100 mg tablets] loading dose on Day 1 followed by 100 mg once daily maintenance dose for the remainder of the study) for the prevention of major vascular events (composite of stroke, myocardial infarction [MI], and death) in patients with acute ischaemic stroke or transient ischaemic attack (TIA).

Carotid revascularization for primary prevention of stroke (CREST-2) is two independent multicenter, randomized controlled trials of carotid revascularization and intensive medical management versus medical management alone in patients with asymptomatic high-grade carotid stenosis. One trial will randomize patients in a 1:1 ratio to endarterectomy versus no endarterectomy and another will randomize patients in a 1:1 ratio to carotid stenting with embolic protection versus no stenting. Medical management will be uniform for all randomized treatment groups and will be centrally directed.

We want to determine if treating acute ischemic stroke patients who have evidence of hypoxemia due to sleep apnea with low flow O2 during sleep might help improve clinical and functional outcomes.

The purpose of this study is to test for the long-term outcomes in function for stroke patients who get an early tracheostomy, versus those who have prolonged orotracheal intubation. 

Patients with severe ischemic and hemorrhagic strokes, who require mechanical ventilation, have a particularly bad prognosis. If they require long-term ventilation, their orotracheal tube needs to be, like in any other intensive care patient, replaced by a shorter tracheal tube below the larynx. This so called tracheostomy might be associated with advantages such as less demand of narcotics and pain killers, less lesions in mouth and ...

The purpose of this study is to learn how uterine fibroids may be connected to heart disease and high blood pressure. It is not known what causes fibroids, but they frequently occur in women who also have high blood pressure, heart disease, and stroke. The investigators of this study want to learn if certain changes in the blood vessels or nerve activity can put women at risk for these diseases and for fibroids.

The purpose of this study is to compare the relatively new procedure of stent-assisted carotid angioplasty to the traditional and accepted surgical approach of carotid endarterectomy for the treatment of carotid artery stenosis to prevent recurrent strokes in those patients who have had a TIA (transient ischemic attack) or a mild stroke within the past 6 months (symptomatic) and in those patients who have not had any symptoms within the past 6 months (asymptomatic).

The purpose o fthis study

A total of 8,000 patients presenting to CPSs with acute-onset AIS, ICH or aSAH and no history of dementia will be enrolled within 6 weeks of stroke onset.

All participants will undergo baseline screening for evidence of pre-stroke dementia. Those who pass baseline screening will complete a blood draw and a series of cognitive and functional assessments at baseline.

Participants will undergo in-person (3-6 months, 18 months) and telephone (annual) follow-up visits for the duration of the study to assess for longitudinal cognitive and functional outcomes. In addition to Tier 1 procedures, at each in-person follow-up visit: Tier ...

Obstructive Sleep Apnea (OSA) is a condition in which a person stops breathing for several seconds at a time due to relaxation of the throat muscles. This can occur many times during sleep and is known to cause sleepiness and poor concentration during the day. Research indicates that OSA may be a modifiable risk factor for cardiovascular disease due to its association with hypertension, stroke, heart attack and sudden death. The standard therapy for symptomatic OSA is continuous positive airway pressure (CPAP). CPAP has been shown to effectively reduce snoring, obstructive episodes and daytime sleepiness and to modestly reduce blood pressure ...

This study is being done to collect skin samples from people with and without neurodegenerative and vascular disorders including Parkinson’s disease (PD), Alzheimer’s disease (AD), amyotrophic lateral sclerosis (ALS), stroke and many others. We will use these skin samples to make and bank (store) a group of cells (cell line) called inducible pluripotent stem (iPS) cells.

The purpose of this study is to identify important physiologic trends in bedside ICU data such as cerebral perfusion pressure (CPP), intracranial pressure (ICP) using a bedside “Multimodal monitoring” (MMM) computer which utilizes ICM+ Cambridge software.

The overall objective of our network of investigators is to develop and conduct clinical trials and other large multi-centre studies in childhood stroke. Our specific aims are:

Objective 1: To ascertain in a prospective, consecutive cohort study the numbers of newborns and children with ischemic stroke, their stroke sub-types and risk factors, their current treatments and outcomes within our centers. These data will provide the rationale and feasibility data for our group to design and implement the initial randomized controlled trials (RCTs) in paediatric stroke as well as other fundable grant proposals.

Objective 2: To develop standardized data ...

Study summary:

The overall plan for this study is to conduct qualitative interviews among 40 family members of patients who have been hospitalized in a coma. Subjects for this study will be recruited by local site P.I.s from intensive care units at the following 18 U.S. centers:

All interviews will be conducted virtually via video conferencing by study staff at the Yale School of Medicine and Massachusetts General Hospital. All study activities following the interviews, including data analysis and manuscript writing, will take place at the Yale School of Medicine and Massachusetts General Hospital. We expect ...

The primary purpose of this study is to determine if apixaban is superior to aspirin for prevention of the composite outcome of any stroke (hemorrhagic or ischemic) or death from any cause in patients with recent ICH and atrial fibrillation (AF).

C3FIT’s overall goal is to assess if patient outcomes are improved when the Comprehensive and Primary Stroke Center (CSC/PSC) system is supplemented with an Integrated Stroke Practice Unit (ISPU) system of care, a patient-centric model of care involving the patient and caregiver/family that coordinates care from the acute management through the rehabilitation and recovery of the patient.

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

The purpose of this study is to verify that high Premature Ventricular Complex (PVC) burden is associated with increased risk of stroke and/or Transient Ischemic Attack (TIA), to examine outcomes such as stroke/TIA, atrial fibrillation/flutter, and all-cause mortality associated with PVCs, and to evaluate whether PVCs are associated with development of appendage dysfunction.

The purpose of this study is to determine whether treatment of obstructive sleep apnea (OSA) with positive airway pressure starting shortly after acute ischemic stroke or high risk TIA (1) reduces recurrent stroke, acute coronary syndrome, and all-cause mortality 6 months after the event, and (2) improves stroke outcomes at 3 months in patients who experienced an ischemic stroke.

The purpose of this study is to create and maintain a clinical database of patients with history of, or who are at high risk for thromboembolic diseases, along with a plasma/serum repository. We plan to evaluate novel biomarkers that might be associated with thromboembolic diseases and test whether these biomarkers will help predict the incident and recurrentrecurrences of thromboembolic episodes and other outcomes (e.g., mortality, post thrombotic syndrome).

The purpose of this study is to evaluate the effietiveness of remdesivir (RDV) in reducing the rate of of all-cause medically attended visits (MAVs; medical visits attended in person by the participant and a health care professional) or death in non-hospitalized participants with early stage coronavirus disease 2019 (COVID-19) and to evaluate the safety of RDV administered in an outpatient setting.

The aim of this study is to create a state-wide biorepository and resource center for cerebrovascular diseases in Florida. The Center will collect and store detailed phenotypic information, DNA, and other biofluids on affected subjects with diverse cerebrovascular conditions, including, but not limited to, ischemic stroke, transient ischemic attack (TIA), intracerebral hemorrhage (ICH), aneurysmal subarachnoid hemorrhage (aSAH), vascular dementia (VAD), anoxic brain injury, unruptured intracranial aneurysm (UIA), cavernous malformation, arteriovenous malformations (AVM), carotid and vertebral arterial dissections, symptomatic and asymptomatic cervical carotid artery atherosclerotic stenosis, non-aneurysmal perimesencephalic subarachnoid hemorrhage (naSAH), cerebral venous thrombosis (CVT), moyamoya disease, fibrosmuscular dysplasia (FMD), non-traumatic, angiography-negative subarachnoid ...