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  • SAGE Publications  (11)
  • Alexandrov, Andrei V.  (11)
  • 1
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    Neurological manifestations and implications of COVID-19 pandemic
    SAGE Publications ; 2020
    In:  Therapeutic Advances in Neurological Disorders Vol. 13 ( 2020-01), p. 175628642093203-
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    In: Therapeutic Advances in Neurological Disorders, SAGE Publications, Vol. 13 ( 2020-01), p. 175628642093203-
    Abstract: The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) emerged in Wuhan, China and rapidly spread worldwide, with a vast majority of confirmed cases presenting with respiratory symptoms. Potential neurological manifestations and their pathophysiological mechanisms have not been thoroughly established. In this narrative review, we sought to present the neurological manifestations associated with coronavirus disease 2019 (COVID-19). Case reports, case series, editorials, reviews, case-control and cohort studies were evaluated, and relevant information was abstracted. Various reports of neurological manifestations of previous coronavirus epidemics provide a roadmap regarding potential neurological complications of COVID-19, due to many shared characteristics between these viruses and SARS-CoV-2. Studies from the current pandemic are accumulating and report COVID-19 patients presenting with dizziness, headache, myalgias, hypogeusia and hyposmia, but also with more serious manifestations including polyneuropathy, myositis, cerebrovascular diseases, encephalitis and encephalopathy. However, discrimination between causal relationship and incidental comorbidity is often difficult. Severe COVID-19 shares common risk factors with cerebrovascular diseases, and it is currently unclear whether the infection per se represents an independent stroke risk factor. Regardless of any direct or indirect neurological manifestations, the COVID-19 pandemic has a huge impact on the management of neurological patients, whether infected or not. In particular, the majority of stroke services worldwide have been negatively influenced in terms of care delivery and fear to access healthcare services. The effect on healthcare quality in the field of other neurological diseases is additionally evaluated.
    Type of Medium: Online Resource
    ISSN: 1756-2864 , 1756-2864
    URL: Article
    DOI: 10.1177/1756286420932036
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
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  • 2
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    Outcomes following Sonothrombolysis in Severe Acute Ischemic Stroke: Subgroup Analysis of the CLOTBUST Trial
    SAGE Publications ; 2014
    In:  International Journal of Stroke Vol. 9, No. 8 ( 2014-12), p. 1006-1010
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 9, No. 8 ( 2014-12), p. 1006-1010
    Abstract: Sonothrombolysis is safe and may increase the likelihood of early recanalization in acute ischemic stroke patients. Aims In preparation of a phase III clinical trial, we contrast the likelihood of achieving a sustained recanalization and functional independence in a post hoc subgroup analysis of patients randomized to transcranial Doppler monitoring plus intravenous tissue plasminogen activator (sonothrombolysis) compared with intravenous tissue plasminogen activator alone in the CLOTBUST trial. Methods We analyzed the data from all randomized acute ischemic stroke patients with pretreatment National Institutes of Health Stroke Scale scores ≥ 10 points and proximal intracranial occlusions in the CLOTBUST trial. We compared sustained complete recanalization rate (Thrombolysis in Brain Ischemia flow grades 4–5) and functional independence (modified Rankin Scale 0–1) at 90 days. Safety was evaluated by the rate of symptomatic intracranial hemorrhage within 72 h of stroke onset. Results Of 126 patients, a total of 85 acute ischemic stroke patients met our inclusion criteria: mean age 71 ± 11years, 56% men, median National Institutes of Health Stroke Scale 17 (interquartile range 14–20). Of these patients, 41 (48%) and 44 (52%) were randomized to intravenous tissue plasminogen activator alone and sonothrombolysis, respectively. More patients achieved sustained complete recanalization in the sonothrombolysis than in the intravenous tissue plasminogen activator alone group (38·6% vs. 17·1%; P = 0·032). Functional independence at 90 days was more frequently achieved in the sonothrombolysis than in the intravenous tissue plasminogen activator alone group (37·2% vs. 15·8%; P = 0·045). Symptomatic intracranial hemorrhage rate was similar in both groups (4·9% vs. 4·6%; P = 1·00). Conclusions Our results point to a signal of efficacy and provide information to guide the subsequent phase III randomized trial of sonothrombolysis in patients with severe ischemic strokes.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/ijs.12340
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2014
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  • 3
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    International beliefs and head positioning practices in patients with spontaneous hyperacute intracerebral hemorrhage
    SAGE Publications ; 2023
    In:  Therapeutic Advances in Neurological Disorders Vol. 16 ( 2023-01), p. 175628642311611-
    Details
    In: Therapeutic Advances in Neurological Disorders, SAGE Publications, Vol. 16 ( 2023-01), p. 175628642311611-
    Abstract: Prior to the conduct of the Head Position in Stroke Trial (HeadPoST), an international survey ( n = 128) revealed equipoise for selection of head position in acute ischemic stroke. Objectives: We aimed to determine whether equipoise exists for head position in spontaneous hyperacute intracerebral hemorrhage (ICH) patients following HeadPoST. Design: This is an international, web-distributed survey focused on head positioning in hyperacute ICH patients. Methods: A survey was constructed to examine clinicians’ beliefs and practices associated with head positioning of hyperacute ICH patients. Survey items were developed with content experts, piloted, and then refined before distributing through stroke listservs, social media, and purposive snowball sampling. Data were analyzed using descriptive statistics and χ 2 test. Results: We received 181 responses representing 13 countries on four continents: 38% advanced practice providers, 32% bedside nurses, and 30% physicians; overall, participants had median 7 [interquartile range (IQR) = 3–12] years stroke experience with a median of 100 (IQR = 37.5–200) ICH admissions managed annually. Participants disagreed that HeadPoST provided ‘definitive evidence’ for head position in ICH and agreed that their ‘written admission orders include 30-degree head positioning’, with 54% citing hospital policies for this head position in hyperacute ICH. Participants were unsure whether head positioning alone could influence ICH longitudinal outcomes. Use of serial proximal clinical and technology measures during the head positioning intervention were identified by 82% as the most appropriate endpoints for future ICH head positioning trials. Conclusion: Interdisciplinary providers remain unconvinced by HeadPoST results that head position does not matter in hyperacute ICH. Future trials examining the proximal effects of head positioning on clinical stability in hyperacute ICH are warranted.
    Type of Medium: Online Resource
    ISSN: 1756-2864 , 1756-2864
    URL: Article
    DOI: 10.1177/17562864231161162
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
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  • 4
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    Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke
    SAGE Publications ; 2019
    In:  Therapeutic Advances in Neurological Disorders Vol. 12 ( 2019-01), p. 175628641986065-
    Details
    In: Therapeutic Advances in Neurological Disorders, SAGE Publications, Vol. 12 ( 2019-01), p. 175628641986065-
    Abstract: Results of our recently published phase III randomized clinical trial of ultrasound-enhanced thrombolysis (sonothrombolysis) using an operator-independent, high frequency ultrasound device revealed heterogeneity of patient recruitment among centers. Methods: We performed a post hoc analysis after excluding subjects that were recruited at centers reporting a decline in the balance of randomization between sonothrombolysis and concurrent endovascular trials. Results: From a total of 676 participants randomized in the CLOTBUST-ER trial we identified 52 patients from 7 centers with perceived equipoise shift in favor of endovascular treatment. Post hoc sensitivity analysis in the intention-to-treat population adjusted for age, National Institutes of Health Scale score at baseline, time from stroke onset to tPA bolus and baseline serum glucose showed a significant (p  〈  0.01) interaction of perceived endovascular equipoise shift on the association between sonothrombolysis and 3 month functional outcome [adjusted common odds ratio (cOR) in centers with perceived endovascular equipoise shift: 0.22, 95% CI 0.06–0.75; p = 0.02; adjusted cOR for centers without endovascular equipoise shift: 1.20, 95% CI 0.89–1.62; p = 0.24)]. After excluding centers with perceived endovascular equipoise shift, patients randomized to sonothrombolysis had higher odds of 3 month functional independence (mRS scores 0–2) compared with patients treated with tPA only (adjusted OR: 1.53; 95% CI 1.01–2.31; p = 0.04). Conclusion: Our experience in CLOTBUST-ER indicates that increasing implementation of endovascular therapies across major academic stroke centers raises significant challenges for clinical trials aiming to test noninterventional or adjuvant reperfusion strategies.
    Type of Medium: Online Resource
    ISSN: 1756-2864 , 1756-2864
    URL: Article
    DOI: 10.1177/1756286419860652
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2019
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  • 5
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    Combined Lysis of Thrombus with Ultrasound and Systemic Tissue Plasminogen Activator for Emergent Revascularization in Acute Ischemic Stroke (Clotbust-ER): Design and Methodology of a Multinational Phase 3 Trial
    SAGE Publications ; 2015
    In:  International Journal of Stroke Vol. 10, No. 7 ( 2015-10), p. 1141-1148
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 10, No. 7 ( 2015-10), p. 1141-1148
    Abstract: We designed a Phase 3 clinical trial to determine the safety and efficacy of adding transcranial ultrasound using an operator-independent headframe to recombinant tissue-plasminogen-activator for the treatment of acute ischemic stroke. Methods Combined lysis of thrombus with ultrasound and systemic tissue-plasminogen-activator for emergent revascularization in acute ischemic stroke is a randomized, double-blind, placebo-controlled clinical trial that will enroll subjects with the following main inclusion criteria: less than 4·5 hours from symptom onset (three-hours in US and Canada), age 18–80 years, baseline National Institutes of Health Stroke Scale score ≥ 10, and premorbid modified-Rankin-score of 0–1, eligibility for full dose recombinant tissue-plasminogen-activator. Subjects will receive two-hours of 2-MHz pulsed wave transcranial ultrasound (target group) or sham ultrasound (control group). The projected sample size is approximately 824 subjects. Results The primary endpoint, based on intention-to-treat criteria of patients enrolled within three-hours of symptom onset is the comparison between target and control groups of modified-Rankin-score scores at day 90 poststroke assessed using the proportional odds method. The study will have two planned interim analyses after approximately one-third and two-thirds of subjects have reached the 90-day modified-Rankin-score evaluation. Safety outcomes are symptomatic intracranial hemorrhage within 24 h and an overall analysis of adverse events. Conclusions Since intravenous recombinant tissue-plasminogen-activator remains the only medical therapy to reverse ischemic stroke applicable in the emergency department, our trial will determine if the additional use of transcranial ultrasound improves functional outcomes in patients with severe acute ischemic stroke (NCT#01098981).
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/ijs.12536
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2015
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  • 6
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    Safety and Dose-Escalation Study Design of Transcranial Ultrasound in Clinical Sonolysis for Acute Ischemic Stroke: The TUCSON Trial
    SAGE Publications ; 2009
    In:  International Journal of Stroke Vol. 4, No. 1 ( 2009-02), p. 42-48
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 4, No. 1 ( 2009-02), p. 42-48
    Abstract: Transcranial Doppler (TCD) monitoring during intravenous tissue plasminogen activator (i.v.-tPA) infusion increases recanalization rates in acute ischemic stroke. Addition of perflutren-lipid microspheres MRX-801 (μS) may further enhance the process of recanalization. This article describes the design of the Transcranial Ultrasound in Clinical SONolysis (TUCSON) trial. Aims and Design TUCSON is a phase I-II, randomized, placebo-controlled, open-label, safety, dose-escalation clinical trial of μS+TCD ultrasound (sonolysis). Patients with acute ischemic stroke and arterial intracranial occlusions are enrolled within 3 h of symptom onset. All patients receive standard i.v.-tPA and will be randomized to 90 min of continuous 2-MHz TCD+μS or 90 min of saline+brief TCD vessel assessments. The safety profile of four escalating dose tiers will be assessed. Arterial occlusions and recanalization are defined with the Thrombolysis in Brain Ischemia flow grades. Study Outcomes Safety is determined by the rates of symptomatic intracerebral hemorrhage within 36 h. Neurological deficits and outcomes are measured with the National Institute of Health Stroke Scale and modified Rankin Scale (mRS). The signal-of-efficacy is determined by rates of recanalization, dramatic or early clinical recovery within 2 h, clinical recovery at 24–36 h and independent outcome (mRS 0–2) at 90 days.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/j.1747-4949.2009.00252.x
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2009
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  • 7
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    Reperfusion and Outcomes in Penumbra Vs. Systemic Tissue Plasminogen Activator Clinical Trials
    SAGE Publications ; 2011
    In:  International Journal of Stroke Vol. 6, No. 2 ( 2011-04), p. 118-122
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 6, No. 2 ( 2011-04), p. 118-122
    Abstract: An uncontrolled clinical study of the Penumbra ™ system showed high rates of recanalisation and relatively poor functional outcomes that were inadequately compared with historic controls. We aimed to compare the findings in Penumbra with intravenous tissue plasminogen activator trials that determined recanalisation (Combined Lysis Of Thrombus in Brain ischaemia using transcranial Ultrasound and Systemic tissue plasminogen activator and Transcranial Ultrasound in Clinical Sonothrombolysis). Methods Control patients treated with intravenous tissue plasminogen activator and intermittent ultrasound surveillance had National Institutes of Health Stroke Scale scores 〉 7. The Penumbra trial definition of symptomatic intracranial haemorrhage was used. Revascularisation was defined using thrombolysis in brain ischaemia scores predictive of thrombolysis in myocardial infarction flow grades and compared with thrombolysis in myocardial infarction data from Penumbra. Favourable functional outcomes was defined as a modified Rankin Scale of 0–2. Results Pretreatment stroke severity (National Institutes of Health Stroke Scale score) was 17·6 ± 5·2 points in Penumbra patients ( n=125) and 16·3 ± 5·3 in controls ( n=68; P=0·101). The control group was older compared with Penumbra (68·8 ± 13·4 vs. 63·5 ± 13·5-years; P=0·010). Time-to-treatment initiation was on average 2 h later (2·3 ± 0·6 vs. 4·3 ± 1·5 h; P 〈 0·001) in Penumbra. The rate of any revascularisation after treatment with Penumbra was higher than that following intravenous thrombolysis: 82% (54% thrombolysis in myocardial infarction II and 27% thrombolysis in myocardial infarction III) vs. 40% (25% partial, 15% complete revascularisation), P 〈 0·001. Symptomatic intracranial haemorrhage tended to be higher with Penumbra (11·2% vs. 4·4%; P=0·182, Fisher's exact test). At three-months, mortality with Penumbra was higher (32·8%) than controls (14·1%; P=0·006). Favourable functional outcomes were higher in historic controls (39% vs. 25%; P=0·046). Conclusions Despite lower revascularisation rates, patients treated with systemic thrombolysis achieved better functional outcomes likely due to earlier treatment initiation. These data indicate that it is unrealistic to expect primary intraarterial revascularisation to be any better than systemic plasminogen activator within the 3-h time window. Improvements in the speed of delivery and performance of intraarterial reperfusion are needed.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/j.1747-4949.2010.00559.x
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2011
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  • 8
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    Embolic strokes of undetermined source: theoretical construct or useful clinical tool?
    SAGE Publications ; 2019
    In:  Therapeutic Advances in Neurological Disorders Vol. 12 ( 2019-01), p. 175628641985138-
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    In: Therapeutic Advances in Neurological Disorders, SAGE Publications, Vol. 12 ( 2019-01), p. 175628641985138-
    Abstract: In 2014, the definition of embolic strokes of undetermined source (ESUS) emerged as a new clinical construct to characterize cryptogenic stroke (CS) patients with complete vascular workup to determine nonlacunar, nonatherosclerotic strokes of presumable embolic origin. NAVIGATE ESUS, the first phase III randomized-controlled, clinical trial (RCT) comparing rivaroxaban (15 mg daily) with aspirin (100 mg daily), was prematurely terminated for lack of efficacy after enrollment of 7213 patients. Except for the lack of efficacy in the primary outcome, rivaroxaban was associated with increased risk of major bleeding and hemorrhagic stroke compared with aspirin. RE-SPECT ESUS was the second phase III RCT that compared the efficacy and safety of dabigatran (110 or 150 mg, twice daily) to aspirin (100 mg daily). The results of this trial have been recently presented and showed similar efficacy and safety outcomes between dabigatran and aspirin. Indirect analyses of these trials suggest similar efficacy on the risk of ischemic stroke (IS) prevention, but higher intracranial hemorrhage risk in ESUS patients receiving rivaroxaban compared to those receiving dabigatran (indirect HR = 6.63, 95% CI: 1.38–31.76). ESUS constitute a heterogeneous group of patients with embolic cerebral infarction. Occult AF represents the underlying mechanism of cerebral ischemia in the minority of ESUS patients. Other embolic mechanisms (paradoxical embolism via patent foramen ovale, aortic plaque, nonstenosing unstable carotid plaque, etc.) may represent alternative mechanisms of cerebral embolism in ESUS, and may mandate different management than oral anticoagulation. The potential clinical utility of ESUS may be challenged since the concept failed to identify patients who would benefit from anticoagulation therapy. Compared with the former diagnosis of CS, ESUS patients required thorough investigations; more comprehensive diagnostic work-up than is requested in current ESUS diagnostic criteria may assist clinicians in uncovering the source of brain embolism in CS patients and individualize treatment approaches.
    Type of Medium: Online Resource
    ISSN: 1756-2864 , 1756-2864
    URL: Article
    DOI: 10.1177/1756286419851381
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2019
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  • 9
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    Off-label use of intravenous thrombolysis for acute ischemic stroke: a critical appraisal of randomized and real-world evidence
    SAGE Publications ; 2021
    In:  Therapeutic Advances in Neurological Disorders Vol. 14 ( 2021-01), p. 175628642199736-
    Details
    In: Therapeutic Advances in Neurological Disorders, SAGE Publications, Vol. 14 ( 2021-01), p. 175628642199736-
    Abstract: Intravenous thrombolysis (IVT) represents the only systemic reperfusion therapy able to reverse neurological deficit in patients with acute ischemic stroke (AIS). Despite its effectiveness in patients with or without large vessel occlusion, it can be offered only to a minority of them, because of the short therapeutic window and additional contraindications derived from stringent but arbitrary inclusion and exclusion criteria used in landmark randomized controlled clinical trials. Many absolute or relative contraindications lead to disparities between the official drug label and guidelines or expert recommendations. Based on recent advances in neuroimaging and evidence from cohort studies, off-label use of IVT is increasingly incorporated into the daily practice of many stroke centers. They relate to extension of therapeutic time windows, and expansion of indications in co-existing conditions originally listed in exclusion criteria, such as use of alternative thrombolytic agents, pre-treatment with antiplatelets, anticoagulants or low molecular weight heparins. In this narrative review, we summarize recent randomized and real-world data on the safety and efficacy of off-label use of IVT for AIS. We also make some practical recommendations to stroke physicians regarding the off-label use of thrombolytic agents in complex and uncommon presentations of AIS or other conditions mimicking acute cerebral ischemia. Finally, we provide guidance on the risks and benefits of IVT in numerous AIS subgroups, where equipoise exists and guidelines and treatment practices vary.
    Type of Medium: Online Resource
    ISSN: 1756-2864 , 1756-2864
    URL: Article
    DOI: 10.1177/1756286421997368
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2021
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  • 10
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    Design of a Prospective Multi-National CLOTBUST Collaboration on Reperfusion Therapies for Stroke
    SAGE Publications ; 2008
    In:  International Journal of Stroke Vol. 3, No. 1 ( 2008-02), p. 66-72
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 3, No. 1 ( 2008-02), p. 66-72
    Abstract: The benefit of intravenous (i.v.) tissue plasminogen activator (tPA) in acute ischemic stroke (IS) is attributable to lysis of thrombus and restoration of perfusion to ischemic but not yet infarcted brain. Aims Our multicentre collaborative group prospectively implemented a protocol for transcranial Doppler assessment of intracranial recanalization with tPA treatment based on the CLOTBUST clinical trial (CLOTBUST-PRO). We aim to determine whether early recanalization (within 1 h from tPA bolus) is independently associated with better 3-month outcome in patients with intracranial arterial occlusions and correlates to a shorter time interval elapsed from symptom onset to tPA bolus. Subjects and methods Consecutive patients with acute IS due to intracranial arterial occlusions will be treated with standard i.v.-tPA and continuously monitored with 2 MHz Transcranial Doppler for arterial recanalization. Early recanalization will be determined with the previously validated Thrombolysis in Brain Ischemia flow-grading system within 60 min after tPA bolus. Power calculations are based on the assumption of α = 0·05 (two-sided test) and probabilities of functional independence at 3 months of 0·50 and 0·35 in patients with early complete recanalization and persisting occlusion, respectively. Detection of a 15% difference with a power of 0·824 requires an estimated sample of 480 patients of whom 25% are expected to achieve early recanalization while 75% will have persisting occlusion at 1 h after tPA bolus. We also plan to test prespecified secondary hypotheses within the projected study sample. Conclusions CLOTBUST-PRO is designed to determine if the timing (within 1 h from tPA bolus) of tPA-induced arterial recanalization is an independent determinant of 3-month functional recovery. We also seek to demonstrate that the sooner the tPA is given to stroke patients, the earlier the recanalization occurs and the greater is the likelihood of functional independence at 3 months. Introduction Intravenous (i.v.) tissue plasminogen activator (tPA) remains the only approved therapy for acute ischemic stroke (IS) with faster time to treatment being associated with better outcomes at 3 months ( 1 ). Although the benefit of tPA is attributable to lysis of thrombus and restoration of perfusion to ischemic but not yet infarcted brain ( 2 ), recanalization was not documented in pivotal tPA trials. This hypothesis is supported by both animal and smaller human studies showing that the duration of impaired perfusion is associated with final infarct volume and that early recanalization correlates with smaller infarct size ( 3 – 5 ).
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/j.1747-4949.2008.00167.x
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2008
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