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Stroke, Ischemic clinical trials

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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

NCT ID: NCT03655964 Recruiting - Stroke, Ischemic Clinical Trials

Effect of Olmesartan and Nebivolol on Ambulatory Blood Pressure and Arterial Stiffness in Acute Stage of Ischemic Stroke

Start date: August 20, 2018
Phase: Phase 2
Study type: Interventional

Single-blind, randomized, active-treatment controlled clinical study evaluating the effect of omesartan and nebivolol versus no treatment on 24-hour brachial and central aortic blood pressure in hypertensive patients with acute ischemic stroke

NCT ID: NCT03649711 Recruiting - Clinical trials for Chronic Kidney Diseases

Chronic Kidney Disease (CKD) Platelet Study

Start date: September 1, 2018
Phase: Phase 3
Study type: Interventional

This study evaluates how aspirin, clopidogrel and ticagrelor work in people with chronic kidney disease (CKD) compared to people with normal kidneys. In the first part of the study, half of CKD participants will be randomly assigned to ticagrelor and aspirin, while the other half will be assigned to clopidogrel and aspirin in a blinded fashion. The treatment duration will be two weeks. After recruiting CKD participants the investigator will recruit controls with normal kidney function that will receive only ticagrelor and aspirin for two weeks.

NCT ID: NCT03649295 Recruiting - Stroke, Ischemic Clinical Trials

Combined Conventional Speech Therapy and Functional Electrical Stimulation in Dysphagia Following Stroke

Start date: February 20, 2018
Phase: N/A
Study type: Interventional

This study will evaluate the effectiveness of conventional speech therapy associated with functional electrical stimulation in patients with dysphagia after ischemic stroke. Included patients will be divided into two groups, where in the intervention group the speech therapy is associated to functional electrical stimulation, and in the control group, the patients will receive the conventional speech therapy with electrical stimulation Placebo with intensity 0hz.

NCT ID: NCT03648957 Not yet recruiting - Clinical trials for Transient Ischemic Attack

Lifestyle Counselling as Secondary Prevention in Patients With Minor Stroke and Transient Ischemic Attack

Start date: September 1, 2018
Phase: N/A
Study type: Interventional

Interventions to improve health behaviour in patients with resent acute stroke are not well established. This study will evaluate the feasibility and effect of an early initiated counselling intervention targeting smoking, physical activity, and adherence to preventive medication, with regular follow-up sessions, in patients with acute minor stroke or transient ischemic attack who are discharged home.

NCT ID: NCT03621917 Recruiting - Acute Stroke Clinical Trials

Evaluation of tPA Efficacy in Acute Stroke Patients With NIRS (Near-infrared Spectroscopy)

E-NESE
Start date: November 1, 2017
Phase:
Study type: Observational

Investigators aim to study efficiency of systemic thrombolytic therapy on acute ischemic stroke patients with near infrared spectroscopy.

NCT ID: NCT03621826 Enrolling by invitation - Sickle Cell Disease Clinical Trials

Evaluating Barriers to Stroke Screening and Prevention in Children With Sickle Cell Disease

DISPLACE
Start date: February 12, 2018
Phase:
Study type: Observational

DISPLACE is a three part, multi-center U.S. based study to evaluate the barriers to stroke screening and prevention in children with sickle cell anemia (SCA). In the United States, TCD (Transcranial Doppler ultrasound) is a proven method of screening children with SCA for stroke. However, many children are not getting the screening they need. This study will examine the issues that hinder and help children get the screening at 28 different hospitals and sickle cell centers to improve care for all children with sickle cell anemia. The investigators will then plan a study (part 3) aimed to improve stroke screening and prevention in sickle cell anemia.

NCT ID: NCT03609385 Recruiting - Clinical trials for Acute Coronary Syndrome

PRediction of Acute Coronary Syndrome in Acute Ischemic StrokE

PRAISE
Start date: August 1, 2018
Phase:
Study type: Observational

The primary goal of the PRAISE study is to develop a diagnostic algorithm that allows the prediction of acute coronary syndrome in stroke patients with elevated levels of cardiac troponin.

NCT ID: NCT03605381 Not yet recruiting - Depression Clinical Trials

MORbidity PRevalence Estimate In StrokE

MORe PREcISE
Start date: August 31, 2018
Phase:
Study type: Observational

Information regarding the likely progress of post-stroke symptoms is vitally important to stroke survivors to allow them to plan for the future and to adjust to life after stroke. Moreover, the prevalence of morbidity secondary to stroke is of central importance to Health Professionals to understand the prognosis of the disease in the patients under their care. Additionally, it will also allow commissioners of care, planners and third sector organisations to adapt to and answer the needs of a post-stroke population. Currently, the data collected by national audit programmes are concentrated on what can be termed 'process or process of care' data. The utility of these data are in the ability to audit the care received by stroke survivors on stroke units against evidenced standards for care, thus ensuring evidence based practice. Nevertheless, process of care is only one form of measuring stroke unit care and the audit programmes collect some limited functional status data, data relating to risk-factor co-morbidities and treatment received data. Therefore, the scope of this study is to build on the minimum data set currently collected and to collect post-stroke data in domains not currently collected. The International Consortium for Health Outcomes Measurement (ICHOM) takes important steps to collect data outside of process of care data such as a Patient Reported outcome data in their minimum outcome data set for stroke [currently under review].. Nevertheless, the ICHOM doesn't currently advocate the specific collection of data relating to cognitive impairment or emotional problems secondary to stroke. It is in these important aspects that this study will augment the data set currently advocated by ICHOM to collect data in the areas of cognitive impairment and emotional problems secondary to stroke. Therefore, the aim of this study is to quantify the prevalence of morbidity at six months post-stroke.