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Stroke clinical trials

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https://www.readbyqxmd.com/read/28741665/remote-ischemic-preconditioning-and-clinical-outcomes-in-on-pump-coronary-artery-bypass-grafting-a-meta-analysis-of-14-randomized-controlled-trials
#1
Bin Yi, Jianhui Wang, Dingwu Yi, Yanling Zhu, Yumei Jiang, Yi Li, Shaoyan Mo, Yi Liu, Jian Rong
The purpose of this article is to perform the first pooled analysis on remote ischemic preconditioning (RIPC) used for the improvement of clinical outcomes of patients only undergoing on-pump coronary artery bypass grafting (CABG) in randomized controlled trials (RCTs). A systematic search was performed using PubMed, the Cochrane Library, and the Web of Science to identify studies that described the effect of RIPC on postoperative mortality in patients only undergoing on-pump CABG. The outcomes included postoperative mortality, postoperative morbidity (including incidence of myocardial infarction, atrial fibrillation, stroke, acute kidney injury, and renal replacement therapy), mechanical ventilation (MV), intensive care unit length of stay (ICU LOS), and hospital length of stay (HLOS)...
July 25, 2017: Artificial Organs
https://www.readbyqxmd.com/read/28741405/optimized-tpa-a-non-neurotoxic-fibrinolytic-agent-for-the-drainage-of-intracerebral-hemorrhages
#2
Romain Goulay, Mikaël Naveau, Thomas Gaberel, Denis Vivien, Jérôme Parcq
Intracerebral hemorrhage (ICH) is the most severe form of stroke. Catheter-delivered thrombolysis with recombinant tissue-type plasminogen activator (rtPA) for the drainage of ICH is currently under evaluation in a phase III clinical trial (MISTIE III). However, in a pig model of ICH, in situ fibrinolysis with rtPA was reported to increase peri-lesional edema by promoting N-methyl-D-aspartate (NMDA)-dependent excitotoxicity. In the present study, we engineered a non-neurotoxic tPA variant, OptPA, and investigated its safety and efficacy for in situ fibrinolysis in a rat model of ICH...
January 1, 2017: Journal of Cerebral Blood Flow and Metabolism
https://www.readbyqxmd.com/read/28739198/efficacy-and-safety-of-apixaban-versus-warfarin-in-patients-with-atrial-fibrillation-and-a-history-of-cancer-insights-from-the-aristotle-trial
#3
Chiara Melloni, Allison Dunning, Christopher B Granger, Laine Thomas, Michel G Khouri, David A Garcia, Elaine M Hylek, Michael Hanna, Lars Wallentin, Bernard J Gersh, Pamela S Douglas, John H Alexander, Renato D Lopes
BACKGROUND: Cancer is associated with a prothrombotic state and increases risk of thrombotic events in patients with atrial fibrillation. We described clinical characteristics and outcomes and assessed safety and efficacy of apixaban versus warfarin in patients with atrial fibrillation and cancer in ARISTOTLE. METHODS AND RESULTS: The association between cancer and clinical outcomes was assessed using Cox regression models. At baseline, 1236 (6.8%) patients had a history of cancer; 12...
July 21, 2017: American Journal of Medicine
https://www.readbyqxmd.com/read/28737102/comparative-effectiveness-of-rivaroxaban-in-the-treatment-of-nonvalvular-atrial-fibrillation
#4
Faye L Norby, Alvaro Alonso
Rivaroxaban is a direct oral anticoagulant (DOAC) approved for the prevention of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, a common arrhythmia. In this review, we summarize the effectiveness of rivaroxaban versus warfarin and the DOACs dabigatran, apixaban and edoxaban. The primary focus is on primary evidence from clinical trials, indirect comparison studies and real-world studies. While there are gaps in the literature, the evidence thus far indicates that rivaroxaban is superior to warfarin and similar to dabigatran, apixaban and edoxaban for the prevention of stroke or systemic embolism in patients with nonvalvular atrial fibrillation, although rivaroxaban may be associated with an elevated bleeding risk compared with other DOACs...
July 24, 2017: Journal of Comparative Effectiveness Research
https://www.readbyqxmd.com/read/28736561/recent-advances-in-stroke-prevention-in-patients-with-atrial-fibrillation-and-end-stage-renal-disease
#5
REVIEW
Federico Ronco, Patrizio Mazzone, Leila Hosseinian, Simonetta Genovesi
BACKGROUND: Chronic kidney disease (CKD) is associated with a high prevalence of atrial fibrillation (AF), but in this population the risk/benefit ratio of anticoagulant therapy with vitamin K antagonists (VKA) for thromboprophylaxis is uncertain. SUMMARY: In end-stage renal disease (ESRD) patients undergoing hemodialysis, VKA seem less effective in stroke prevention than in the general population, with an increased risk of major bleeding. Recently, novel oral anticoagulant agents (NOACs) have proven to be effective for stroke prevention in AF and have demonstrated an improved safety profile compared to VKA...
June 2017: Cardiorenal Medicine
https://www.readbyqxmd.com/read/28735873/the-therapeutic-potential-of-purinergic-signalling
#6
REVIEW
Geoffrey Burnstock
This review is focused on the pathophysiology and therapeutic potential of purinergic signalling. A wide range of diseases are considered, including those of the central nervous system, skin, kidney, musculoskeletal, liver gut, lower urinary tract, cardiovascular, airways and reproductive systems, the special senses, infection, diabetes and obesity. Several purinergic drugs are already on the market, including P2Y12 receptor antagonists for stroke and thrombosis, P2Y2 receptor agonists for dry eye, A1 receptor agonists for supraventricular tachycardia...
July 20, 2017: Biochemical Pharmacology
https://www.readbyqxmd.com/read/28733782/catheter-ablation-of-atrial-fibrillation-an-overview-for-clinicians
#7
REVIEW
Nebojša Mujović, Milan Marinković, Radoslaw Lenarczyk, Roland Tilz, Tatjana S Potpara
Catheter ablation (CA) of atrial fibrillation (AF) is currently one of the most commonly performed electrophysiology procedures. Ablation of paroxysmal AF is based on the elimination of triggers by pulmonary vein isolation (PVI), while different strategies for additional AF substrate modification on top of PVI have been proposed for ablation of persistent AF. Nowadays, various technologies for AF ablation are available. The radiofrequency point-by-point ablation navigated by electro-anatomical mapping system and cryo-balloon technology are comparable in terms of the efficacy and safety of the PVI procedure...
July 21, 2017: Advances in Therapy
https://www.readbyqxmd.com/read/28733071/long-term-stroke-and-bleeding-risk-in-patients-with-atrial-fibrillation-treated-with-oral-anticoagulants-in-contemporary-practice-providing-evidence-for-shared-decision-making
#8
Peter A Noseworthy, Xiaoxi Yao, Bernard J Gersh, Ian Hargraves, Nilay D Shah, Victor M Montori
BACKGROUND: Oral anticoagulation is recommended as a lifelong therapy for most patients with atrial fibrillation (AF). However, data on long-term outcomes in clinical practice on these drugs are scarce, particularly for the recently approved agents. We aimed to describe differences in characteristics between patients in everyday practice and those enrolled in the pivotal trials, and to report long-term outcomes on oral anticoagulation in practice. METHODS: We performed a retrospective cohort analysis using a large U...
July 14, 2017: International Journal of Cardiology
https://www.readbyqxmd.com/read/28731036/stroke-in-women-from-evidence-to-inequalities
#9
REVIEW
Charlotte Cordonnier, Nikola Sprigg, Else Charlotte Sandset, Aleksandra Pavlovic, Katharina S Sunnerhagen, Valeria Caso, Hanne Christensen
Stroke is the second largest cause of disability-adjusted life-years lost worldwide. The prevalence of stroke in women is predicted to rise rapidly, owing to the increasing average age of the global female population. Vascular risk factors differ between women and men in terms of prevalence, and evidence increasingly supports the clinical importance of sex differences in stroke. The influence of some risk factors for stroke - including diabetes mellitus and atrial fibrillation - are stronger in women, and hypertensive disorders of pregnancy also affect the risk of stroke decades after pregnancy...
July 21, 2017: Nature Reviews. Neurology
https://www.readbyqxmd.com/read/28730951/penumbra-and-re-canalization-acute-computed-tomography-in-ischemic-stroke-evaluation-practise-study-protocol
#10
Salwa El-Tawil, Joanna Wardlaw, Ian Ford, Grant Mair, Tom Robinson, Lalit Kalra, Keith W Muir
Rationale Multimodal imaging, including computed tomography angiography and computed tomography perfusion imaging, yields additional information on intracranial vessels and brain perfusion and can differentiate between ischemic core and penumbra which may affect patient selection for intravenous thrombolysis. Hypothesis The use of multimodal imaging will increase the number of patients receiving intravenous thrombolysis and lead to better treatment outcomes. Sample size 400 patients. Methods and design PRACTISE is a prospective, multicenter, randomized, controlled trial in which patients presenting within 4...
August 2017: International Journal of Stroke: Official Journal of the International Stroke Society
https://www.readbyqxmd.com/read/28730950/statistical-analysis-plan-for-the-head-position-in-stroke-trial-headpost-an-international-cluster-cross-over-randomized-trial
#11
Laurent Billot, Mark Woodward, Hisatomi Arima, Maree L Hackett, Paula Muñoz Venturelli, Pablo M Lavados, Alejandro Brunser, Bin Peng, Liying Cui, Lily Song, Stephane Heritier, Stephen Jan, Sandy Middleton, Verónica V Olavarría, Joyce Lim, Thompson Robinson, Octavio Pontes-Neto, Caroline Watkins, Craig S Anderson
Background There is evidence to indicate that the lying flat head position increases cerebral blood flow and oxygenation in patients with acute ischemic stroke, but how these physiological effects translate into clinical outcomes is uncertain. The Head Position in Stroke Trial aims to determine the comparative effectiveness of lying flat (0°) compared to sitting up (≥30°) head positioning, initiated within 24 h of hospital admission for patients with acute stroke. Design An international, pragmatic, cluster-randomized, crossover, open, blinded outcome assessed clinical trial...
August 2017: International Journal of Stroke: Official Journal of the International Stroke Society
https://www.readbyqxmd.com/read/28730949/eric-acute-stroke-recanalization-a-study-using-predictive-analytics-to-assess-a-new-device-for-mechanical-thrombectomy
#12
Susanne Siemonsen, Nils D Forkert, Martina Bernhardt, Götz Thomalla, Martin Bendszus, Jens Fiehler
Aim and hypothesis Using a new study design, we investigate whether next-generation mechanical thrombectomy devices improve clinical outcomes in ischemic stroke patients. We hypothesize that this new methodology is superior to intravenous tissue plasminogen activator therapy alone. Methods and design ERic Acute StrokE Recanalization is an investigator-initiated prospective single-arm, multicenter, controlled, open label study to compare the safety and effectiveness of a new recanalization device and distal access catheter in acute ischemic stroke patients with symptoms attributable to acute ischemic stroke and vessel occlusion of the internal cerebral artery or middle cerebral artery...
August 2017: International Journal of Stroke: Official Journal of the International Stroke Society
https://www.readbyqxmd.com/read/28730849/treadmill-training-to-improve-mobility-for-people-with-sub-acute-stroke-a-phase-ii-feasibility-randomized-controlled-trial
#13
Gillian D Baer, Lisa G Salisbury, Mark T Smith, Jane Pitman, Martin Dennis
OBJECTIVE: This phase II study investigated the feasibility and potential effectiveness of treadmill training versus normal gait re-education for ambulant and non-ambulant people with sub-acute stroke delivered as part of normal clinical practice. DESIGN: A single-blind, feasibility randomized controlled trial. SETTING: Four hospital-based stroke units. SUBJECTS: Participants within three months of stroke onset. INTERVENTIONS: Participants were randomized to treadmill training (minimum twice weekly) plus normal gait re-education or normal gait re-education only (control) for up to eight weeks...
July 1, 2017: Clinical Rehabilitation
https://www.readbyqxmd.com/read/28730267/phantom-based-standardization-of-ct-angiography-images-for-spot-sign-detection
#14
Andrea Morotti, Javier M Romero, Michael J Jessel, Andrew M Hernandez, Anastasia Vashkevich, Kristin Schwab, Joseph D Burns, Qaisar A Shah, Thomas A Bergman, M Fareed K Suri, Mustapha Ezzeddine, Jawad F Kirmani, Sachin Agarwal, Angela Hays Shapshak, Steven R Messe, Chitra Venkatasubramanian, Katherine Palmieri, Christopher Lewandowski, Tiffany R Chang, Ira Chang, David Z Rose, Wade Smith, Chung Y Hsu, Chun-Lin Liu, Li-Ming Lien, Chen-Yu Hsiao, Toru Iwama, Mohammad Rauf Afzal, Christy Cassarly, Steven M Greenberg, Renee' Hebert Martin, Adnan I Qureshi, Jonathan Rosand, John M Boone, Joshua N Goldstein
PURPOSE: The CT angiography (CTA) spot sign is a strong predictor of hematoma expansion in intracerebral hemorrhage (ICH). However, CTA parameters vary widely across centers and may negatively impact spot sign accuracy in predicting ICH expansion. We developed a CT iodine calibration phantom that was scanned at different institutions in a large multicenter ICH clinical trial to determine the effect of image standardization on spot sign detection and performance. METHODS: A custom phantom containing known concentrations of iodine was designed and scanned using the stroke CT protocol at each institution...
July 20, 2017: Neuroradiology
https://www.readbyqxmd.com/read/28729407/long-term-stroke-risk-prediction-in-patients-with-atrial-fibrillation-comparison-of-the-abc-stroke-and-cha2ds2-vasc-scores
#15
José Miguel Rivera-Caravaca, Vanessa Roldán, María Asunción Esteve-Pastor, Mariano Valdés, Vicente Vicente, Gregory Y H Lip, Francisco Marín
BACKGROUND: The ABC-stroke score (age, biomarkers [N-terminal fragment B-type natriuretic peptide, high-sensitivity troponin], and clinical history [prior stroke/transient ischemic attack]) was proposed to predict stroke in atrial fibrillation (AF). This score was derived/validated in 2 clinical trial cohorts in which patients with AF were highly selected and carefully followed-up. However, the median follow-up was 1.9 years in the trial cohort; therefore, its long-term predictive performance remains uncertain...
July 20, 2017: Journal of the American Heart Association
https://www.readbyqxmd.com/read/28729311/a-review-of-rate-control-in-atrial-fibrillation-and-the-rationale-and-protocol-for-the-rate-af-trial
#16
Dipak Kotecha, Melanie Calvert, Jonathan J Deeks, Michael Griffith, Paulus Kirchhof, Gregory Yh Lip, Samir Mehta, Gemma Slinn, Mary Stanbury, Richard P Steeds, Jonathan N Townend
BACKGROUND AND OBJECTIVE: Atrial fibrillation (AF) is common and causes impaired quality of life, an increased risk of stroke and death as well as frequent hospital admissions. The majority of patients with AF require control of heart rate. In this article , we summarise the limited evidence from clinical trials that guides prescription, and present the rationale and protocol for a new randomised trial. As rate control has not yet been shown to reduce mortality, there is a clear need to compare the impact of therapy on quality of life, cardiac function and exercise capacity...
July 20, 2017: BMJ Open
https://www.readbyqxmd.com/read/28728960/effect-of-high-intensity-home-based-respiratory-muscle-training-on-strength-of-respiratory-muscles-following-a-stroke-a-protocol-for-a-randomized-controlled-trial
#17
Kênia Kiefer Parreiras De Menezes, Lucas Rodrigues Nascimento, Janaine Cunha Polese, Louise Ada, Luci Fuscaldi Teixeira-Salmela
BACKGROUND: Respiratory muscle training has shown to increase strength of the respiratory muscles following a stroke. However, low duration and/or intensity of training may be responsible for the small effect size seen and/or absence of carry-over effects to an activity, e.g., walking. Therefore, an investigation of the effects of long-duration, high-intensity respiratory muscle training is warranted. OBJECTIVE: This proposed protocol for a randomized clinical trial will examine the efficacy of high-intensity respiratory muscle training to increase strength and improve activity following a stroke...
July 3, 2017: Brazilian Journal of Physical Therapy
https://www.readbyqxmd.com/read/28728688/transcatheter-versus-surgical-aortic%C3%A2-valve%C3%A2-replacement-propensity-matched-comparison
#18
J Matthew Brennan, Laine Thomas, David J Cohen, David Shahian, Alice Wang, Michael J Mack, David R Holmes, Fred H Edwards, Naftali Z Frankel, Suzanne J Baron, John Carroll, Vinod Thourani, E Murat Tuzcu, Suzanne V Arnold, Roberta Cohn, Todd Maser, Brenda Schawe, Susan Strong, Allen Stickfort, Elizabeth Patrick-Lake, Felicia L Graham, Dadi Dai, Fan Li, Roland A Matsouaka, Sean O'Brien, Fan Li, Michael J Pencina, Eric D Peterson
BACKGROUND: Randomized trials support the use of transcatheter aortic valve replacement (TAVR) for the treatment of aortic stenosis in high- and intermediate-risk patients, but the generalizability of those results in clinical practice has been challenged. OBJECTIVES: The aim of this study was to determine the safety and effectiveness of TAVR versus surgical aortic valve replacement (SAVR), particularly in intermediate- and high-risk patients, in a nationally representative real-world cohort...
July 25, 2017: Journal of the American College of Cardiology
https://www.readbyqxmd.com/read/28728602/robot-assisted-training-for-the-upper-limb-after-stroke-ratuls-study-protocol-for-a-randomised-controlled-trial
#19
Helen Rodgers, Lisa Shaw, Helen Bosomworth, Lydia Aird, Natasha Alvarado, Sreeman Andole, David L Cohen, Jesse Dawson, Janet Eyre, Tracy Finch, Gary A Ford, Jennifer Hislop, Steven Hogg, Denise Howel, Niall Hughes, Hermano Igo Krebs, Christopher Price, Lynn Rochester, Elaine Stamp, Laura Ternent, Duncan Turner, Luke Vale, Elizabeth Warburton, Frederike van Wijck, Scott Wilkes
BACKGROUND: Loss of arm function is a common and distressing consequence of stroke. We describe the protocol for a pragmatic, multicentre randomised controlled trial to determine whether robot-assisted training improves upper limb function following stroke. METHODS/DESIGN: Study design: a pragmatic, three-arm, multicentre randomised controlled trial, economic analysis and process evaluation. SETTING: NHS stroke services. PARTICIPANTS: adults with acute or chronic first-ever stroke (1 week to 5 years post stroke) causing moderate to severe upper limb functional limitation...
July 20, 2017: Trials
https://www.readbyqxmd.com/read/28728489/idarucizumab-for-the-treatment-of-hemorrhage-and-dabigatran-reversal-in-patients-requiring-urgent-surgery-or-procedures
#20
Ovidiu Vornicu, Anne-Sophie Larock, Anne-Sophie Dincq, Jonathan Douxfils, Jean-Michel Dogné, François Mullier, Sarah Lessire
Idarucizumab is a specific antagonist for dabigatran etexilate (DE). The recent market authorization of idarucizumab in Europe and the USA may reassure prescribers of DE, as it can increase the safety of the emergency management of patients taking this anticoagulant. However, idarucizumab use should be limited to specific indications to avoid unnecessary risks to patients and costs to healthcare systems. Areas covered: The authors provide an overview of idarucizumab development and its pharmacokinetic and pharmacodynamic properties...
July 20, 2017: Expert Opinion on Biological Therapy
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