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Stroke clinical trials

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NCT ID: NCT02879448 Active, not recruiting - Stroke Clinical Trials

AMPLATZER™ Amulet™ LAA Occluder Trial

Amulet IDE
Start date: August 24, 2016
Phase: N/A
Study type: Interventional

The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the Amulet device or the WATCHMAN device and will be followed for 5 years after device implant.

NCT ID: NCT02830152 Active, not recruiting - Stroke Clinical Trials

Prevention of Stroke by Left Atrial Appendage Closure in Atrial Fibrillation Patients After Intracerebral Hemorrhage

Start date: May 3, 2017
Phase: N/A
Study type: Interventional

Intracerebral hemorrhage (ICH) in patients with non-valvular atrial fibrillation (NVAF) poses a particular dilemma for thromboprophylaxis. Left atrial appendage occlusion (LAAO) is a non-pharmacological approach to prevent cardiac embolism in NVAF. The risk-benefit ratio of LAAO in patients with NVAF after ICH is unknown. The aim of STROKECLOSE is to assess the effect of LAAO to reduce the incidence stroke, bleeding and cardiovascular mortality in patients with NVAF and prior ICH.

NCT ID: NCT02813889 Active, not recruiting - Stroke Clinical Trials

SmarToyGym: Smart Detection of Atypical Toy-oriented Actions in At-risk Infants

Start date: May 2015
Phase: N/A
Study type: Interventional

The study aims to develop a SmarToyGym where sensitized, wireless toys are strategically hung and placed within reach of infants to elicit toy-oriented body and arm/hand movements. Each toy will be equipped with sensors capable of measuring the infant's grasping actions such as squeezing, pinching, tilting, etc. A low-cost 3D motion capture system will be used to collect video data and the infants' reaching and body kinematics in response to the toys. A pressure mat will be used to measure postural changes to detect weight shifts, rolling, crawling and other movements away from the initial posture. By capitalizing on these wireless and low-cost technologies, it will permit the regular and non-invasive monitoring of infants, which can lead to detailed, non-obtrusive, quantitative evaluation of motor development. In this vein, the investigators also aim to conduct proof-of-concept testing of the SmarToyGym with atypical and typical developing infants. The investigators will include infants' ages 3 to 11 months who are categorized as high-risk or low-risk using the Bayley Infant Neurodevelopmental Screener.

NCT ID: NCT02807012 Active, not recruiting - Stroke Clinical Trials

Nursing Home Care Intervention Post Stroke

SHARE
Start date: May 2016
Phase: N/A
Study type: Interventional

Associated with the worsening of functional capacity of older adult and the lack of guidance on how to care of them after stroke, the family caregiver starts to fell burden related to the care, and the quality of life was affected by that burden. Besides that, the older adult began to use more frequently health services and had more hospitalizations by preventable conditionals with adequate care. The aim of this study is to evaluate the effectiveness of educational interventions of care at home provide by nurses to family caregivers of older adult with stroke after hospital discharge, compared with usual care guidelines or no guidance, in one month follow up. The family caregivers of older adults post stroke with the first functional sequel from the Clinical Hospital of Porto Alegre (HCPA) will participate in the study. The intervention will involve the systematic monitoring of nurses through home visits (HVs) during one month. Thus, will instrumentalize the family caregiver to care of older adult with stoke according the protocol developed in a research group and the needs of care of them. The control group won't receive the home visits and could have or not the usual care guidelines provide by health services that have access.

NCT ID: NCT02791880 Active, not recruiting - Stroke Clinical Trials

Acute Kidney Injury Genomics and Biomarkers in TAVR Study

Start date: October 25, 2016
Phase:
Study type: Observational

In the last decade, transcatheter aortic valve replacement (TAVR) has become an increasingly utilized alternative procedure for replacing a stenotic aortic valve. This study collects clinical information, DNA, blood and urine samples (throughout procedural hospitalization) in order to investigate the incidence of acute kidney injury (AKI) in patients undergoing TAVR and to identify key clinical and procedural predictors of AKI. This study seeks to identify blood and urine biomarkers that can be used for early detection of AKI around the time of the procedure. The study seeks to assess for novel genetic variants associated with development of AKI after TAVR. Finally the study seeks to assess for novel genetic variants and biomarkers that are associated with adverse cardiovascular events after TAVR and to further explore how these events may inter-relate with acute kidney injury.

NCT ID: NCT02753257 Active, not recruiting - Stroke Clinical Trials

Validation of Sensitivity and Specificity of a Multi-Omic Precision Diagnostic for Acute Stroke Evaluation

VALISS
Start date: September 2016
Phase:
Study type: Observational

Valtari Bio has early proof of concept clinical data of a multi-omic peripheral blood biomarker profile that can be used to determine stroke from no stroke in the emergency setting. The objective of this observational cohort clinical study is to determine the clinical utility of this multi-omic biomarker profile. Primary Study Aims: 1. The diagnostic tests characteristics of a multi-omic biomarker diagnostic for stroke (ischemic stroke, transient ischemic attack (TIA) and hemorrhagic stroke) versus no stroke (stroke mimic). 2. The ability of a multi-omic biomarker profile to differentiate ischemic stroke from hemorrhagic stroke and TIA.

NCT ID: NCT02743416 Active, not recruiting - Stroke Clinical Trials

Systematic NT-proBNP and ECG Screening for Atrial Fibrillation Among 75 Year Old Subjects in the Region of Stockholm, Sweden - STROKESTOP II

STROKESTOP II
Start date: April 2016
Phase:
Study type: Observational [Patient Registry]

STROKESTOP II will study if the biomarker NT-proBNP together with single-lead ECG can be used as a primary population screening tool for silent atrial fibrillation, and builds on previous results from the STROKESTOP study.

NCT ID: NCT02737189 Active, not recruiting - Ischemic Stroke Clinical Trials

Basilar Artery Occlusion Chinese Endovascular Trial

Start date: July 2016
Phase: N/A
Study type: Interventional

Endovascular treatment of acute ischemic stroke has shown strong benefit in several prospective randomized trials in the anterior circulation and endovascular therapy for basilar artery occlusion has shown promising results in several single-arm studies. This has led to a broad adoption of these techniques which are now considered standard of care in many institutions despite the lack of adequate evidence to prove their benefit. Indeed, the rates of symptomatic intracerebral hemorrhage in these studies have consistently been around 5% which raises the question as to whether patients could actually be harmed as opposed to helped by these procedures. This is a prospective, multi-center, randomized, controlled, open, blinded-endpoint trial, with the aim to evaluate the hypothesis that mechanical embolectomy with the Solitaire device is superior to medical management alone in achieving better outcomes in subjects presenting with an acute ischemic stroke caused by occlusion of the basilar artery within 6-24 hours from symptom onset.

NCT ID: NCT02736747 Active, not recruiting - Stroke Clinical Trials

Effects of Cryotherapy on Ankle Movements and Gait of Spastic Hemiparetic Subjects

Start date: April 2016
Phase: N/A
Study type: Interventional

The stroke has been described as the third cause of death and main cause of disability in the worldwide population. About 60% of the survivors are able to walk following the rehabilitation process, however deficits on lower limbs functions often persists in most cases, affecting the gait and functional mobility. In this sense, several interventions are applied in the clinical practice to optimize the functional performance. Cryotherapy is one of the most used techniques aiming to reduce spasticity temporarily, allowing the training of functional tasks, such as walking. The aim of the present study is to evaluate the immediate effects of cryotherapy (ice pack) on neuromuscular performance, proprioception, passive resistance of dorsiflexors and plantarflexors muscles, and also on gait performance in chronic post-stroke subjects. Eighteen chronic hemiparetic subjects will participate in this crossover placebo-controlled trial. The order of intervention (cryotherapy or placebo) will be randomized. Fifteen days of washout period will be considered. The cryotherapy/placebo will be applied on the posterior area of the leg for 20 minutes. Initially Fugl Meyer will be applied. All other assessments will be performed before and after intervention: spasticity level, classified according to Modified Ashworth Scale; temporo-spatial and angular parameters for trunk, hip, knee and ankle during gait, using a motion analysis system (Qualysis AB, Gothenburg, Sweden); the proprioception (joint position sense), passive resistance to stretching, isometric and isokinetic torques during contractions of plantarflexors and dorsiflexors of the ankle, evaluated through isokinetic dynamometer. Concomitantly, bilateral activation of soleus, gastrocnemius, tibialis anterior and peroneus will be assessed by electromyography during isokinetic dynamometer assessment and gait. The following electromyographic variables will be analyzed: maximum activation amplitude, muscle onset, coactivation index between agonists and antagonists. For statistical analysis, normality (Shapiro Wilk) and homogeneity (Levene) tests will be applied. If the variables have a distribution considered normal and homogeneous, Two-way ANOVA with repeated measures will be applied. Otherwise, non-parametric statistics (Friedman test) will be applied. A significance level of 0.05 will be considered for all statistical tests.

NCT ID: NCT02731235 Active, not recruiting - Stroke, Lacunar Clinical Trials

The Effect of Aerobic Exercise in Patients With Lacunar Stroke

HITPALS
Start date: January 2016
Phase: N/A
Study type: Interventional

In a randomized-controlled study the effect of high-intensity training, 5 days a week at home for 12 weeks is tested in patients with lacunar stroke.