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  • SAGE Publications  (10)
  • Churilov, Leonid  (10)
  • Yan, Bernard  (10)
  • 1
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    Smartphone electrographic monitoring for atrial fibrillation in acute ischemic stroke and transient ischemic attack
    SAGE Publications ; 2017
    In:  International Journal of Stroke Vol. 12, No. 7 ( 2017-10), p. 786-789
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 12, No. 7 ( 2017-10), p. 786-789
    Abstract: Paroxysmal atrial fibrillation is a common and preventable cause of devastating strokes. However, currently available monitoring methods, including Holter monitoring, cardiac telemetry and event loop recorders, have drawbacks that restrict their application in the general stroke population. AliveCor™ heart monitor, a novel device that embeds miniaturized electrocardiography (ECG) in a smartphone case coupled with an application to record and diagnose the ECG, has recently been shown to provide an accurate and sensitive single lead ECG diagnosis of atrial fibrillation. This device could be used by nurses to record a 30-s ECG instead of manual pulse taking and automatically provide a diagnosis of atrial fibrillation. Aims To compare the proportion of patients with paroxysmal atrial fibrillation detected by AliveCor™ ECG monitoring with current standard practice. Sample size 296 Patients. Design Consecutive ischemic stroke and transient ischemic attack patients presenting to participating stroke units without known atrial fibrillation will undergo intermittent AliveCor™ ECG monitoring administered by nursing staff at the same frequency as the vital observations of pulse and blood pressure until discharge, in addition to the standard testing paradigm of each participating stroke unit to detect paroxysmal atrial fibrillation. Study outcome Proportion of patients with paroxysmal atrial fibrillation detected by AliveCor™ ECG monitoring compared to 12-lead ECG, 24-h Holter monitoring and cardiac telemetry. Discussion Use of AliveCor™ heart monitor as part of routine stroke unit nursing observation has the potential to be an inexpensive non-invasive method to increase paroxysmal atrial fibrillation detection, leading to improvement in stroke secondary prevention.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493017696097
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2017
    detail.hit.zdb_id: 2211666-7
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  • 2
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    The Spot Sign and Tranexamic Acid on Preventing ICH Growth – AUStralasia Trial (STOP-AUST): Protocol of a Phase II Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial
    SAGE Publications ; 2014
    In:  International Journal of Stroke Vol. 9, No. 4 ( 2014-06), p. 519-524
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 9, No. 4 ( 2014-06), p. 519-524
    Abstract: No evidence-based acute therapies exist for intracerebral hemorrhage. Intracerebral hemorrhage growth is an important determinant of patient outcome. Tranexamic acid is known to reduce hemorrhage in other conditions. Aim The study aims to test the hypothesis that intracerebral hemorrhage patients selected with computed tomography angiography contrast extravasation ‘spot sign’ will have lower rates of hematoma growth when treated with intravenous tranexamic acid within 4·5-hours of stroke onset compared with placebo. Design The Spot sign and Tranexamic acid On Preventing ICH growth – AUStralasia Trial is a multicenter, prospective, 1:1 randomized, double-blind, placebo-controlled, investigator-initiated, academic Phase II trial. Intracerebral hemorrhage patients fulfilling clinical criteria (e.g. Glasgow Coma Scale 〉 7, intracerebral hemorrhage volume 〈 70 ml, no identified secondary cause of intracerebral hemorrhage, no thrombotic events within the previous 12 months, no planned surgery) and demonstrating contrast extravasation on computed tomography angiography will receive either intravenous tranexamic acid 1 g 10-min bolus followed by 1 g eight-hour infusion or placebo. A second computed tomography will be performed at 24 ± 3 hours to evaluate intracerebral hemorrhage growth and patients followed up for three-months. Study outcomes The primary outcome measure is presence of intracerebral hemorrhage growth by 24 ± 3 hours, defined as either 〉 33% or 〉 6 ml increase from baseline, and will be adjusted for baseline intracerebral hemorrhage volume. Secondary outcome measures include growth as a continuous measure, thromboembolic events, and the three-month modified Rankin Scale score. Discussion This is the first trial to evaluate the efficacy of tranexamic acid in intracerebral hemorrhage patients selected based on an imaging biomarker of high likelihood of hematoma growth. The trial is registered as NCT01702636.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/ijs.12132
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2014
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  • 3
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    Cost-effectiveness of tenecteplase versus alteplase for stroke thrombolysis evaluation trial in the ambulance
    SAGE Publications ; 2023
    In:  European Stroke Journal Vol. 8, No. 2 ( 2023-06), p. 448-455
    Details
    In: European Stroke Journal, SAGE Publications, Vol. 8, No. 2 ( 2023-06), p. 448-455
    Abstract: Tenecteplase administered to patients with ischaemic stroke in a mobile stroke unit (MSU) has been shown to reduce the perfusion lesion volumes and result in ultra-early recovery. We now seek to assess the cost-effectiveness of tenecteplase in the MSU. Methods: A within-trial (TASTE-A) economic analysis and a model-based long-term cost-effectiveness analysis were performed. This post hoc within-trial economic analysis utilised the patient-level data (intention to treat, ITT) prospectively collected over the trial to calculate the difference in both healthcare costs and quality-adjusted life years (QALYs, estimated from modified Rankin scale score). A Markov microsimulation model was developed to simulate the long-term costs and benefits. Results: In total, there were 104 patients with ischaemic stroke randomised to tenecteplase ( n = 55) or alteplase ( n = 49) treatment groups, respectively in the TASTE-A trial. The ITT-based analysis showed that treatment with tenecteplase was associated with non-signficantly lower costs (A$28,903 vs A$40,150 ( p = 0.056)) and greater benefits (0.171 vs 0.158 ( p = 0.457)) than that for the alteplase group over the first 90 days post the index stroke. The long-term model showed that tenecteplase led to greater savings in costs (−A$18,610) and more health benefits (0.47 QALY or 0.31 LY gains). Tenecteplase-treated patients had reduced costs for rehospitalisation (−A$1464), nursing home care (−A$16,767) and nonmedical care (−A$620) per patient. Conclusions: Treatment of ischaemic stroke patients with tenecteplase appeared to be cost-effective and improve QALYs in the MSU setting based on Phase II data. The reduced total cost from tenecteplase was driven by savings from acute hospitalisation and reduce need for nursing home care.
    Type of Medium: Online Resource
    ISSN: 2396-9873 , 2396-9881
    URL: Article
    DOI: 10.1177/23969873231165086
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
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  • 4
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    Tenecteplase versus alteplase before endovascular thrombectomy (EXTEND-IA TNK): A multicenter, randomized, controlled study
    SAGE Publications ; 2018
    In:  International Journal of Stroke Vol. 13, No. 3 ( 2018-04), p. 328-334
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 13, No. 3 ( 2018-04), p. 328-334
    Abstract: Intravenous thrombolysis with alteplase remains standard care prior to thrombectomy for eligible patients within 4.5 h of ischemic stroke onset. However, alteplase only succeeds in reperfusing large vessel arterial occlusion prior to thrombectomy in a minority of patients. We hypothesized that tenecteplase is non-inferior to alteplase in achieving reperfusion at initial angiogram, when administered within 4.5 h of ischemic stroke onset, in patients planned to undergo endovascular therapy. Study design EXTEND-IA TNK is an investigator-initiated, phase II, multicenter, prospective, randomized, open-label, blinded-endpoint non-inferiority study. Eligibility requires a diagnosis of ischemic stroke within 4.5 h of stroke onset, pre-stroke modified Rankin Scale≤3 (no upper age limit), large vessel occlusion (internal carotid, basilar, or middle cerebral artery) on multimodal computed tomography and absence of contraindications to intravenous thrombolysis. Patients are randomized to either IV alteplase (0.9 mg/kg, max 90 mg) or tenecteplase (0.25 mg/kg, max 25 mg) prior to thrombectomy. Study outcomes The primary outcome measure is reperfusion on the initial catheter angiogram, assessed as modified treatment in cerebral infarction 2 b/3 or the absence of retrievable thrombus. Secondary outcomes include modified Rankin Scale at day 90 and favorable clinical response (reduction in National Institutes of Health Stroke Scale by ≥8 points or reaching 0–1) at day 3. Safety outcomes are death and symptomatic intracerebral hemorrhage. Trial registration ClinicalTrials.gov NCT02388061
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493017733935
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2018
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  • 5
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    Determining the optimal dose of tenecteplase before endovascular therapy for ischemic stroke (EXTEND-IA TNK Part 2): A multicenter, randomized, controlled study
    SAGE Publications ; 2020
    In:  International Journal of Stroke Vol. 15, No. 5 ( 2020-07), p. 567-572
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 15, No. 5 ( 2020-07), p. 567-572
    Abstract: Intravenous thrombolysis with tenecteplase is more effective than alteplase in achieving substantial reperfusion at initial angiographic assessment and improves functional outcome. However, the optimal dose of tenecteplase remains uncertain. We hypothesized that 0.40 mg/kg tenecteplase is superior to 0.25 mg/kg tenecteplase in achieving reperfusion at initial angiogram, when administered within 4.5 h of ischemic stroke onset, in patients planned to undergo endovascular therapy. Study design EXTEND-IA TNK part 2 is an investigator-initiated, phase II, multicenter, prospective, randomized, open-label, blinded-endpoint (PROBE) study. Eligibility requires a diagnosis of ischemic stroke within 4.5 h of stroke onset, pre-stroke modified Rankin Scale (mRS)≤3 (no upper age limit), absence of contraindications to intravenous thrombolysis, and large vessel occlusion (internal carotid, basilar, or middle cerebral artery) on multimodal CT. Patients are randomized to IV tenecteplase at either 0.40 mg/kg (max 40 mg) or 0.25 mg/kg (max 25 mg) prior to thrombectomy. Study outcomes The primary outcome measure is reperfusion on the initial catheter angiogram, assessed as modified Treatment In Cerebral Infarction (mTICI) 2b/3, or the absence of retrievable intracranial thrombus. Secondary outcomes include mRS at day 90 and early neurological improvement (reduction in National Institutes of Health Stroke Scale (NIHSS) by ≥8 points or reaching 0–1) at day 3. Safety outcomes are death and symptomatic intracerebral hemorrhage. Trial registration: ClinicalTrials.gov NCT03340493
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493019879652
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
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  • 6
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    A Multicentre, Randomized, Double-Blinded, Placebo-Controlled Phase III Study to Investigate Extending the Time for Thrombolysis in Emergency Neurological Deficits (EXTEND)
    SAGE Publications ; 2012
    In:  International Journal of Stroke Vol. 7, No. 1 ( 2012-01), p. 74-80
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 7, No. 1 ( 2012-01), p. 74-80
    Abstract: Thrombolytic therapy with tissue plasminogen activator is effective for acute ischaemic stroke within 4·5 h of onset. Patients who wake up with stroke are generally ineligible for stroke thrombolysis. We hypothesized that ischaemic stroke patients with significant penumbral mismatch on either magnetic resonance imaging or computer tomography at three- (or 4·5 depending on local guidelines) to nine-hours from stroke onset, or patients with wake-up stroke within nine-hours from midpoint of sleep duration, would have improved clinical outcomes when given tissue plasminogen activator compared to placebo. Study design EXtending the time for Thrombolysis in Emergency Neurological Deficits is an investigator-driven, Phase III, randomized, multicentre, double-blind, placebo-controlled study. Ischaemic stroke patients presenting after the three- or 4·5-h treatment window for tissue plasminogen activator and within nine-hours of stroke onset or with wake-up stroke within nine-hours from the midpoint of sleep duration, who fulfil clinical (National Institutes of Health Stroke Score ≥4–26 and prestroke modified Rankin Scale 〈 2) will undergo magnetic resonance imaging or computer tomography. Patients who also meet imaging criteria (infarct core volume 〈 70 ml, perfusion lesion : infarct core mismatch ratio 〉 1·2, and absolute mismatch 〉 10 ml) will be randomized to either tissue plasminogen activator or placebo. Study outcome The primary outcome measure will be modified Rankin Scale 0–1 at day 90. Clinical secondary outcomes include categorical shift in modified Rankin Scale at 90 days, reduction in the National Institutes of Health Stroke Score by 8 or more points or reaching 0–1 at day 90, recurrent stroke, or death. Imaging secondary outcomes will include symptomatic intracranial haemorrhage, reperfusion and or recanalization at 24 h and infarct growth at day 90.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/j.1747-4949.2011.00730.x
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2012
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  • 7
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    Every 15-Min Delay in Recanalization by Intra-Arterial Therapy in Acute Ischemic Stroke Increases Risk of Poor Outcome
    SAGE Publications ; 2015
    In:  International Journal of Stroke Vol. 10, No. 7 ( 2015-10), p. 1062-1067
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 10, No. 7 ( 2015-10), p. 1062-1067
    Abstract: Intra-arterial therapy has improved recanalization rates compared with intravenous thrombolysis for acute ischemic stroke; however, superior clinical efficacy has not been convincingly demonstrated. Time to recanalization is postulated as a mechanism hindering the efficacy of intra-arterial therapy. Aim To investigate the effects of time to recanalization on clinical outcome postintra-arterial therapy for acute ischemic stroke. Methods Clinical data were collected prospectively for consecutive patients undergoing intra-arterial therapy for acute ischemic stroke at a single center between 2009 and 2013. Ninety-day functional outcome was assessed by the modified Rankin scale. Univariate analyses identified candidate clinical variables for inclusion in the multivariable model; multivariable logistic regression analyses identified variables independently associated with good outcome, defined as modified Rankin scale 0–2. Results One hundred and seven patients were included in the analysis. Median (interquartile range) age was 67 (54–77) years, 41 (38%) were female, and median (interquartile range) baseline National Institute of Health Stroke Severity score was 18 (13–22). Median time from symptom onset to recanalization was 330 min (interquartile range 277–397). Fifty-four (50%) patients achieved a favorable modified Rankin scale at 90 days. Age, successful recanalization, and time to recanalization were independently associated with good outcome at 90 days in multivariable logistic regression analysis. For every 15 min delay in recanalization, the odds of good outcome decreased by 10%. Conclusions Longer time to recanalization was associated with poorer functional outcome post intra-arterial therapy. We recommend that a systematic approach to minimize time delay to treatment is warranted in intra-arterial therapy for acute ischemic stroke.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/ijs.12495
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2015
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  • 8
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    Association between pre-treatment perfusion profile and cerebral edema after reperfusion therapies in ischemic stroke
    SAGE Publications ; 2021
    In:  Journal of Cerebral Blood Flow & Metabolism Vol. 41, No. 11 ( 2021-11), p. 2887-2896
    Details
    In: Journal of Cerebral Blood Flow & Metabolism, SAGE Publications, Vol. 41, No. 11 ( 2021-11), p. 2887-2896
    Abstract: The relationship between reperfusion and edema is unclear, with experimental and clinical data yielding conflicting results. We investigated whether the extent of salvageable and irreversibly-injured tissue at baseline influenced the effect of therapeutic reperfusion on cerebral edema. In a pooled analysis of 415 patients with anterior circulation large vessel occlusion from the Tenecteplase-versus-Alteplase-before-Endovascular-Therapy-for-Ischemic-Stroke (EXTEND-IA TNK) part 1 and 2 trials, associations between core and mismatch volume on pre-treatment CT-Perfusion with cerebral edema at 24-hours, and their interactions with reperfusion were tested. Core volume was associated with increased edema (p  〈  0.001) with no significant interaction with reperfusion (p = 0.82). In comparison, a significant interaction between reperfusion and mismatch volume (p = 0.03) was observed: Mismatch volume was associated with increased edema in the absence of reperfusion (p = 0.009) but not with reperfusion (p = 0.27). When mismatch volume was dichotomized at the median (102 ml), reperfusion was associated with reduced edema in patients with large mismatch volume (p  〈  0.001) but not with smaller mismatch volume (p = 0.35). The effect of reperfusion on edema may be variable and dependent on the physiological state of the cerebral tissue. In patients with small to moderate ischemic core volume, the benefit of reperfusion in reducing edema is related to penumbral salvage.
    Type of Medium: Online Resource
    ISSN: 0271-678X , 1559-7016
    URL: Article
    DOI: 10.1177/0271678X211017696
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2021
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  • 9
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    STroke imAging pRevention and Treatment (START): A Longitudinal Stroke Cohort Study: Clinical Trials Protocol
    SAGE Publications ; 2015
    In:  International Journal of Stroke Vol. 10, No. 4 ( 2015-06), p. 636-644
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 10, No. 4 ( 2015-06), p. 636-644
    Abstract: Stroke and poststroke depression are common and have a profound and ongoing impact on an individual's quality of life. However, reliable biological correlates of poststroke depression and functional outcome have not been well established in humans. Aims Our aim is to identify biological factors, molecular and imaging, associated with poststroke depression and recovery that may be used to guide more targeted interventions. Design In a longitudinal cohort study of 200 stroke survivors, the START – STroke imAging pRevention and Treatment cohort, we will examine the relationship between gene expression, regulator proteins, depression, and functional outcome. Stroke survivors will be investigated at baseline, 24 h, three-days, three-months, and 12 months poststroke for blood-based biological associates and at days 3–7, three-months, and 12 months for depression and functional outcomes. A sub-group ( n = 100), the PrePARE: Prediction and Prevention to Achieve optimal Recovery Endpoints after stroke cohort, will also be investigated for functional and structural changes in putative depression-related brain networks and for additional cognition and activity participation outcomes. Stroke severity, diet, and lifestyle factors that may influence depression will be monitored. The impact of depression on stroke outcomes and participation in previous life activities will be quantified. Study Outcomes Clinical significance lies in the identification of biological factors associated with functional outcome to guide prevention and inform personalized and targeted treatments. Evidence of associations between depression, gene expression and regulator proteins, functional and structural brain changes, lifestyle and functional outcome will provide new insights for mechanism-based models of poststroke depression.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/ijs.12190
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2015
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  • 10
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    A Multicenter, Randomized, Controlled Study to Investigate Extending the Time for Thrombolysis in Emergency Neurological Deficits with Intra-Arterial Therapy (EXTEND-IA)
    SAGE Publications ; 2014
    In:  International Journal of Stroke Vol. 9, No. 1 ( 2014-01), p. 126-132
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 9, No. 1 ( 2014-01), p. 126-132
    Abstract: Thrombolysis with tissue plasminogen activator is proven to reduce disability when given within 4.5 h of ischemic stroke onset. However, tissue plasminogen activator only succeeds in recanalizing large vessel arterial occlusion in a minority of patients. We hypothesized that anterior circulation ischemic stroke patients, selected with ‘dual target’ vessel occlusion and evidence of salvageable brain using computed tomography or magnetic resonance imaging ‘mismatch’ within 4.5 h of onset, would have improved reperfusion and early neurological improvement when treated with intra-arterial clot retrieval after intravenous tissue plasminogen activator compared with intravenous tissue plasminogen activator alone. Study Design EXTEND-IA is an investigator-initiated, phase II, multicenter prospective, randomized, open-label, blinded-endpoint study. Ischemic stroke patients receiving standard 0.9 mg/kg intravenous tissue plasminogen activator within 4.5 h of stroke onset who have good prestroke functional status (modified Rankin Scale 〈 2, no upper age limit) will undergo multimodal computed tomography or magnetic resonance imaging. Patients who also meet dual target imaging criteria: vessel occlusion (internal carotid or middle cerebral artery) and mismatch (perfusion lesion: ischemic core mismatch ratio 〉 1.2, absolute mismatch 〉 10 ml, ischemic core volume 〈 70 ml) will be randomized to either clot retrieval with the Solitaire FR device after full dose intravenous tissue plasminogen activator, or tissue plasminogen activator alone. Study Outcomes The coprimary outcome measure will be reperfusion at 24 h and favorable clinical response (reduction in National Institutes of Health Stroke Scale by ≥8 points or reaching 0–1) at day 3. Secondary outcomes include modified Rankin Scale at day 90, death, and symptomatic intracranial hemorrhage.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/ijs.12206
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2014
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