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Stroke, Ischemic clinical trials

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NCT ID: NCT03764306 Terminated - Stroke, Ischemic Clinical Trials

New Ischemic Cerebral Lesions After Endarterectomy vs. Stenting for the Treatment of Symptomatic Carotid Stenosis

CARECarotid
Start date: May 1, 2015
Phase: N/A
Study type: Interventional

Background and purpose. Even if periprocedural cerebral microembolism associated with carotid endarterectomy or stenting usually does not manifest as clinically overt stroke, neuropsychological disturbances resulting from these events represent an important clinical and socioeconomic problem. Still, it remains unclear whether the use proximal protection can lower the incidence of cerebral embolism associated with the treatment of carotid stenosis. Materials and methods. This was a prospective randomised single-centre study, which was aimed at comparison of surgical eversion endarterectomy with stenting under proximal protection in symptomatic patients. The investigators evaluated the incidence of new ischaemic lesions revealed by the diffusion-weighted magnetic resonance imaging 2-4 days after the treatment and neurologic events.

NCT ID: NCT03753555 Not yet recruiting - Stroke, Ischemic Clinical Trials

The Effect of InTensive Statin in Ischemic Stroke With inTracranial Atherosclerotic Plaques

INSIST-HRMRI
Start date: December 1, 2018
Phase: Phase 4
Study type: Interventional

Intracranial atherosclerotic disease is the most common cause of ischemic stroke that is directly attributed to the progression or rupture of intracranial high-risk plaque in Asia. Many studies mainly from Euro-American population with a focus on extracranial carotid plaque have fully demonstrated the advantages of intensive statin therapy on stabilizing or reversing plaque burden, reversing plaque composition presenting that lipid-rich necrotic core (LRNC) is gradually replaced by fibrous tissue, and even reversing pattern of arterial remodeling to reduce the occurrence of cerebrovascular events. Yet, direct evidence of the effect of intensive statin therapy on intracranial atherosclerotic plaques is lacking and the effect of statin intensity and duration on intracranial plaque burden and composition is still unclear. High resolution magnetic resonance imaging (HRMRI) is a new and non-invasive technique that enable to assess the morphologic characteristics of vascular wall and plaque composition of intracranial artery. Based on above discussion, the investigators conduct this study to further determine the effect of intensive statin in ischemic stroke with intracranial atherosclerotic plaques.

NCT ID: NCT03733431 Not yet recruiting - Stroke Clinical Trials

Non-invasive TRanscutaneous Cervical Vagus Nerve Stimulation as a Treatment for Acute Stroke; Safety and Feasibility Study

TR-VENUS
Start date: December 2018
Phase: N/A
Study type: Interventional

This study aims to determine safety and feasibility of non-invasive transcutaneous cervical Vagus nerve stimulation (nVNS) when delivered promptly after clinical diagnosis of acute stroke. Vagus nerve stimulation will be performed via GammaCore® device. A total of 60 patients will be randomized to each of 3 different groups; 'standard dose' vagal stimulation, 'high dose' vagal stimulation, and 'sham stimulation' (1:1:1 ratio). Adverse device events, serious adverse device events, and feasibility of vagal nerve stimulation at the setting of acute stroke will be evaluated. The study will be performed in a multi-center fashion among stroke centers within TurkStrokeNet Network.

NCT ID: NCT03728153 Not yet recruiting - Acute Stroke Clinical Trials

Measuring Ambulation, Motor, and Behavioral Outcomes With Post-Stroke Fluoxetine in Tanzania

MAMBO
Start date: March 1, 2019
Phase: Phase 2
Study type: Interventional

This is a phase II, randomized study of 120 adults age 18 or above who will prescribed 20mg daily Fluoxetine for 90 days following acute, ischemic stroke.

NCT ID: NCT03726814 Not yet recruiting - Stroke, Ischemic Clinical Trials

A Clinical Study of iEPC Intervent Subjects With Cerebral Hemorrhagic Stroke

Start date: December 2018
Phase: Early Phase 1
Study type: Interventional

This is a single centre、single arm、open-label,to investigate the safety and efficacy of EPC transplantation in the brain

NCT ID: NCT03725865 Not yet recruiting - Stroke, Ischemic Clinical Trials

A Clinical Study of iNSC Intervent Cerebral Hemorrhagic Stroke

Start date: March 2019
Phase: Early Phase 1
Study type: Interventional

This is a single centre、single arm、open-label,to investigate the safety and efficacy of induction of neural stem cells transplantation in the brain

NCT ID: NCT03725137 Not yet recruiting - Cognitive Decline Clinical Trials

Post-stroke Immunological Changes in Younger Stroke Patients

Start date: January 2019
Phase:
Study type: Observational

In the present study, the investigators aim to elucidate the role of T-cells on cognitive decline in younger stroke patients, using repeated cognitive testing, brain imaging, and immunological analyses in the first 9 month after stroke. The examiners will investigate (i) the extent and duration of stroke-induced changes in T cell function within the peripheral blood of patients; (ii) changes within the cytokine spectrum in cerebrospinal fluid, and (iii) post-stroke cognitive functions and functional neural networks. Finally, the plan is to analyse the interaction of patients' T cells co-cultured with a microglial cell line to elucidate central immune alterations.

NCT ID: NCT03724318 Not yet recruiting - Atrial Fibrillation Clinical Trials

Left Atrium Appendage Closure by Surgery-2

LAACS-2
Start date: November 1, 2018
Phase: N/A
Study type: Interventional

Atrial fibrillation is a heart rhythm disorder that often occurs after heart surgery. During atrial fibrillation blood cloths may form, predominantly in the left atrial appendage, a small sac in the wall of the left side of the heart. Some heart surgeons close this appendage to protect against stroke, particularly in patients with a history of atrial fibrillation, yet there is little evidence to support the efficacy and safety of this practice. We therefore conducted the Left Atrial Appendage Closure by Surgery (LAACS) study (2010-2016) were patients in whom the appendage was closed (by chance) suffered fewer brain damages that patients where it remained open. Although encouraging, these results were not only based on strokes, but also on scars without symptoms found in brain scans. The following LAACS-2 study will include a sufficient number of patients to determine whether future guidelines should advise to close systematically the left atrium appendage during a heart operation.

NCT ID: NCT03699397 Not yet recruiting - Stroke, Ischemic Clinical Trials

EEG Controlled Triage in the Ambulance for Acute Ischemic Stroke

ELECTRA-STROKE
Start date: October 2018
Phase: N/A
Study type: Interventional

RATIONALE Endovascular thrombectomy (EVT) is standard treatment for acute ischemic stroke (AIS) if there is a large vessel occlusion in the anterior circulation (LVO-a). Because of its complexity, EVT is performed in selected hospitals only. Currently, approximately half of EVT eligible patients are initially admitted to hospitals that do not provide this therapy. This delays initiation of treatment by approximately an hour, which decreases the chance of a good clinical outcome. Direct presentation of all patients with a suspected AIS in EVT capable hospitals is not feasible, since only approximately 7% of these patients are eligible for EVT. Therefore, an advanced triage method that reliably identifies patients with an LVO-a in the ambulance is necessary. Electroencephalography (EEG) may be suitable for this purpose, as preliminary studies suggest that slow EEG activity in the delta frequency range correlates with lesion location on cerebral imaging. Use of dry electrode EEG caps will enable relatively unexperienced paramedics to perform a reliable measurement without the EEG preparation time associated with 'wet' EEGs. Combined with algorithms for automated signal analysis, the investigators expect the time of EEG recording and analysis to eventually be below five minutes, which would make stroke triage in the ambulance by EEG logistically feasible. HYPOTHESIS The investigators hypothesize that dry electrode cap EEG can be used in patients with a suspected AIS to identify patients with an LVO-a in the ambulance. OBJECTIVE To develop and validate an algorithm based on dry electrode cap EEG data that accurately determines the likelihood of an LVO-a in patients with a suspected AIS in the ambulance. STUDY DESIGN This diagnostic study consists of four phases: Phase 1: Optimization of measurement time and software settings of the dry electrode cap EEG in a non-emergency setting in patients in whom a regular EEG is/will be performed for standard medical care. Phase 2: Optimization of measurement time and software settings of the dry electrode cap EEG in patients close to our target population in a non-emergency setting. Phase 3: Validation of several existing algorithms and development of one or more new algorithms; selection of algorithm with best diagnostic accuracy for validation in phase 4. Phase 4: Validation of the algorithm selected in phase 3 in patients with a suspected AIS in the ambulance, as well as assessment of technical and logistical feasibility of performing EEG with dry electrode caps in patients with a suspected AIS in the ambulance. This phase is the only multicenter phase of this study. STUDY POPULATION Phase 1: Patients in the outpatient clinic of the Clinical Neurophysiology department of the AMC, in whom a regular EEG has been/will be performed for standard medical care. Phase 2: Patients with an AIS admitted to the Neurology ward of the coordinating hospital with an LVO-a (after reperfusion therapy). Phase 3: Patients with a suspected AIS in the emergency room (ER) of the coordinating hospital (before reperfusion therapy). Phase 4: Patients with a suspected AIS in the ambulance. INTERVENTION Performing a dry electrode cap EEG (in phase 1 in the outpatient clinic, in phase 2 during hospital admission, in phase 3 in the ER and in phase 4 in the ambulance). MAIN END POINTS - Primary end point: specificity of dry electrode cap EEG for diagnosis of LVO-a in suspected AIS patients in the ambulance; - Secondary end points: - Developing an algorithm with optimal diagnostic accuracy for LVO-a detection with ambulant EEG; - Sensitivity, positive predictive value (PPV) and negative predictive value (NPV) of dry electrode cap EEG for diagnosis of LVO-a in suspected AIS patients in the ambulance; - Technical and logistical feasibility of performing dry electrode cap EEGs on patients with a suspected AIS in the ambulance; - Diagnostic accuracy of dry electrode cap EEG for diagnosis of LVO-a in the ambulance in an 'enriched' population (a population with a higher incidence of LVO-a compared to the primary target population because it includes, alongside patients with a suspected AIS, patients with a known LVO-a).

NCT ID: NCT03662750 Recruiting - Stroke, Acute Clinical Trials

TSPO PET as a Measure of Post-stroke Brain Inflammation: a Natural History Cohort

Start date: August 31, 2017
Phase: N/A
Study type: Interventional

DESIGN: exploratory, prospective, natural history, imaging cohort study BACKGROUND: Stroke causes a strong inflammatory response in the brain which is thought to contribute to permanent brain damage in stroke patients. To develop new therapies targeting inflammation we need to better understand how inflammation affects the injured brain tissue and how it relates to neurological deficits that directly affect the patients' quality of life. AIMS: To track the extent and location of inflammation in the brain after stroke over a period of 90 days. The study will explore whether the most inflamed areas in the brain undergo the most damage after stroke and correspond to the cognitive and neurological deficits experienced by stroke patients. METHODS: The study involves an initial screening visit and 2 study imaging visits at days 15 and 90 after the stroke episode. Patients will undergo: 1. Two 90-minute brain imaging sessions using Positron Emission Tomography (PET) (involves injection of safe radiotracers which attach to brain immune cell markers TSPOs and light up the inflamed areas in the brain), 2. Two 45-90 minute Magnetic Resonance Imaging (MRI) scanning sessions (include administration of safe chemical contrast agent Gadolinium), 3. Physical and neurological examinations (vital signs, assessments of mobility and cognitive functioning), 4. Blood testing (routine measurements, blood inflammation markers, and genetic testing for TSPO marker). Venous cannula will be inserted into the forearm for the duration of the scans. POPULATION: 15- 25 patients (recruitment will cease once 15 patients have completed the study) ELIGIBILITY: Male and female stroke patients, aged 18-85, with a recent (within last 10 days) ischemic stroke of moderate severity, able and willing to provide informed consent LOCATION: Patients will be recruited at the Charing Cross Hospital, Imperial College Healthcare NHS Trust, and study scans will be performed by Invicro Centre for Imaging Sciences, Hammersmith Hospital DURATION: 18 months FUNDED BY: Biogen Idec Ltd