يعرض 1 - 10 نتائج من 122 نتيجة بحث عن '"Olvert A. Berkhemer"', وقت الاستعلام: 1.36s تنقيح النتائج
  1. 1
    دورية أكاديمية

    المصدر: Journal of Cardiovascular Development and Disease, Vol 10, Iss 6, p 239 (2023)

    الوصف: Computed tomography perfusion (CTP) is frequently used in the triage of ischemic stroke patients for endovascular thrombectomy (EVT). We aimed to quantify the volumetric and spatial agreement of the CTP ischemic core estimated with different thresholds and follow-up MRI infarct volume on diffusion-weighted imaging (DWI). Patients treated with EVT between November 2017 and September 2020 with available baseline CTP and follow-up DWI were included. Data were processed with Philips IntelliSpace Portal using four different thresholds. Follow-up infarct volume was segmented on DWI. In 55 patients, the median DWI volume was 10 mL, and median estimated CTP ischemic core volumes ranged from 10–42 mL. In patients with complete reperfusion, the intraclass correlation coefficient (ICC) showed moderate-good volumetric agreement (range 0.55–0.76). A poor agreement was found for all methods in patients with successful reperfusion (ICC range 0.36–0.45). Spatial agreement (median Dice) was low for all four methods (range 0.17–0.19). Severe core overestimation was most frequently (27%) seen in Method 3 and patients with carotid-T occlusion. Our study shows moderate–good volumetric agreement between ischemic core estimates for four different thresholds and subsequent infarct volume on DWI in EVT-treated patients with complete reperfusion. The spatial agreement was similar to other commercially available software packages.

    وصف الملف: electronic resource

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    دورية أكاديمية
  3. 3
    دورية أكاديمية

    المصدر: Neurointervention, Vol 15, Iss 3, Pp 126-132 (2020)

    الوصف: Purpose In acute middle cerebral artery (MCA) occlusion, collateral vessels provide retrograde supply to the occluded territory. We hypothesized that such collateral flow reduces perfusion of the non-occluded donor region (steal effect). Materials and Methods Patients with an MCA occlusion with opacification of both ipsi- and contralateral anterior cerebral arteries (ACA) on angiography prior to endovascular treatment were selected. Arteriovenous transit time (AVTT) for both ACA territories was compared for different grades of collateral supply to the MCA territory. In addition, the influence of diabetes and hypertension was analyzed. After successful revascularization, AVTT was re-assessed to determine reversibility. Results Forty-one patients were analyzed. An AVTT of 8.6 seconds (standard deviation [SD] 2.4 seconds) was seen in the ACA territory of the affected hemisphere in comparison to 6.6 seconds (SD 2.1 seconds) for the contralateral side (P

    وصف الملف: electronic resource

  4. 4
    دورية أكاديمية

    المؤلفون: Miou S. Koopman, Jan W. Hoving, Manon Kappelhof, Olvert A. Berkhemer, Ludo F. M. Beenen, Wim H. van Zwam, Hugo W. A. M. de Jong, Jan Willem Dankbaar, Diederik W. J. Dippel, Jonathan M. Coutinho, Henk A. Marquering, Bart J. Emmer, Charles B. L. M. Majoie, for the MR CLEAN Registry Investigators, Aad van der Lugt, Yvo B. W. E. M. Roos, Robert J. van Oostenbrugge, Jelis Boiten, Jan Albert Vos, Ivo G. H. Jansen, Maxim J. H. L. Mulder, Robert-Jan B. Goldhoorn, Kars C. J. Compagne, Josje Brouwer, Sanne J. den Hartog, Wouter H. Hinsenveld, Bob Roozenbeek, Adriaan C. G. M. van Es, Wouter J. Schonewille, Marieke J. H. Wermer, Marianne A. A. van Walderveen, Julie Staals, Jeannette Hofmeijer, Jasper M. Martens, Geert J. Lycklama à Nijeholt, Sebastiaan F. de Bruijn, Lukas C. van Dijk, H. Bart van der Worp, Rob H. Lo, Ewoud J. van Dijk, Hieronymus D. Boogaarts, J. de Vries, Paul L. M. de Kort, Julia van Tuijl, Jo P. Peluso, Puck Fransen, Jan S. P. van den Berg, Boudewijn A. A. M. van Hasselt, Leo A. M. Aerden, René J. Dallinga, Maarten Uyttenboogaart, Omid Eschgi, Reinoud P.H. Bokkers, Tobien H. C. M. L. Schreuder, Roel J. J. Heijboer, Koos Keizer, Lonneke S. F. Yo, Heleen M. den Hertog, Emiel J. C. Sturm, Paul J. A. M. Brouwers, Marieke E. S. Sprengers, Sjoerd F. M. Jenniskens, René van den Berg, Albert J. Yoo, Alida A. Postma, Stefan D. Roosendaal, Bas F. W. van der Kallen, Ido R. van den Wijngaard, Joost Bot, Pieter-Jan van Doormaal, Anton Meijer, Elyas Ghariq, Reinoud P. H. Bokkers, Marc P. van Proosdij, G. Menno Krietemeijer, Rob Lo, Dick Gerrits, Wouter Dinkelaar, Auke P. A. Appelman, Bas Hammer, Sjoert Pegge, Anouk van der Hoorn, Saman Vinke, H. Zwenneke Flach, Hester F. Lingsma, Naziha el Ghannouti, Martin Sterrenberg, Wilma Pellikaan, Rita Sprengers, Marjan Elfrink, Michelle Simons, Marjolein Vossers, Joke de Meris, Tamara Vermeulen, Annet Geerlings, Gina van Vemde, Tiny Simons, Gert Messchendorp, Nynke Nicolaij, Hester Bongenaar, Karin Bodde, Sandra Kleijn, Jasmijn Lodico, Hanneke Droste, Maureen Wollaert, Sabrina Verheesen, D. Jeurrissen, Erna Bos, Yvonne Drabbe, Michelle Sandiman, Nicoline Aaldering, Berber Zweedijk, Jocova Vervoort, Eva Ponjee, Sharon Romviel, Karin Kanselaar, Denn Barning, Esmee Venema, Vicky Chalos, Ralph R. Geuskens, Tim van Straaten, Saliha Ergezen, Roger R. M. Harmsma Daan Muijres, Anouk de Jong, Anna M. M. Boers, J. Huguet, P. F. C. Groot, Marieke A. Mens, Katinka R. van Kranendonk, Kilian M. Treurniet, Manon L. Tolhuisen, Heitor Alves, Annick J. Weterings, Eleonora L. F. Kirkels, Lieve M. Schupp, Eva J. H. F. Voogd, Sabine Collette, Adrien E. D. Groot, Natalie E. LeCouffe, Praneeta R. Konduri, Haryadi Prasetya, Nerea Arrarte- Terreros, Lucas A. Ramos

    المصدر: Frontiers in Neurology, Vol 12 (2022)

    الوصف: Background: A considerable proportion of acute ischemic stroke patients treated with endovascular thrombectomy (EVT) are dead or severely disabled at 3 months despite successful reperfusion. Ischemic core imaging biomarkers may help to identify patients who are more likely to have a poor outcome after endovascular thrombectomy (EVT) despite successful reperfusion. We studied the association of CT perfusion-(CTP), CT angiography-(CTA), and non-contrast CT-(NCCT) based imaging markers with poor outcome in patients who underwent EVT in daily clinical practice.Methods: We included EVT-treated patients (July 2016–November 2017) with an anterior circulation occlusion from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands (MR CLEAN) Registry with available baseline CTP, CTA, and NCCT. We used multivariable binary and ordinal logistic regression to analyze the association of CTP ischemic core volume, CTA-Collateral Score (CTA-CS), and Alberta Stroke Program Early CT Score (ASPECTS) with poor outcome (modified Rankin Scale score (mRS) 5-6) and likelihood of having a lower score on the mRS at 90 days.Results: In 201 patients, median core volume was 13 (IQR 5-41) mL. Median ASPECTS was 9 (IQR 8-10). Most patients had grade 2 (83/201; 42%) or grade 3 (28/201; 14%) collaterals. CTP ischemic core volume was associated with poor outcome [aOR per 10 mL 1.02 (95%CI 1.01–1.04)] and lower likelihood of having a lower score on the mRS at 90 days [aOR per 10 mL 0.85 (95% CI 0.78–0.93)]. In multivariable analysis, neither CTA-CS nor ASPECTS were significantly associated with poor outcome or the likelihood of having a lower mRS.Conclusion: In our population of patients treated with EVT in daily clinical practice, CTP ischemic core volume is associated with poor outcome and lower likelihood of shift toward better outcome in contrast to either CTA-CS or ASPECTS.

    وصف الملف: electronic resource

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    دورية أكاديمية

    المصدر: Diagnostics, Vol 12, Iss 8, p 1786 (2022)

    الوصف: Infarct volume (FIV) on follow-up diffusion-weighted imaging (FU-DWI) is only moderately associated with functional outcome in acute ischemic stroke patients. However, FU-DWI may contain other imaging biomarkers that could aid in improving outcome prediction models for acute ischemic stroke. We included FU-DWI data from the HERMES, ISLES, and MR CLEAN-NO IV databases. Lesions were segmented using a deep learning model trained on the HERMES and ISLES datasets. We assessed the performance of three classifiers in predicting functional independence for the MR CLEAN-NO IV trial cohort based on: (1) FIV alone, (2) the most important features obtained from a trained convolutional autoencoder (CAE), and (3) radiomics. Furthermore, we investigated feature importance in the radiomic-feature-based model. For outcome prediction, we included 206 patients: 144 scans were included in the training set, 21 in the validation set, and 41 in the test set. The classifiers that included the CAE and the radiomic features showed AUC values of 0.88 and 0.81, respectively, while the model based on FIV had an AUC of 0.79. This difference was not found to be statistically significant. Feature importance results showed that lesion intensity heterogeneity received more weight than lesion volume in outcome prediction. This study suggests that predictions of functional outcome should not be based on FIV alone and that FU-DWI images capture additional prognostic information.

    وصف الملف: electronic resource

  6. 6
    دورية أكاديمية

    المصدر: Frontiers in Neurology, Vol 11 (2020)

    الوصف: Introduction and Aim: Hemorrhagic transformation (HT) frequently occurs after acute ischemic stroke and negatively influences the functional outcome. Usually, HT is classified by its radiological appearance. Discriminating between the subtypes can be complicated, and interobserver variation is considerable. Therefore, we aim to quantify rather than classify hemorrhage volumes and determine the association of hemorrhage volume with functional outcome in comparison with the European Cooperative Acute Stroke Study II classification.Patients and Methods: We included patients from the MR CLEAN trial with follow-up imaging. Hemorrhage volume was estimated by manual delineation of the lesion, and HT was classified according to the European Cooperative Acute Stroke Study II classification [petechial hemorrhagic infarction types 1 (HI1) and 2 (HI2) and parenchymal hematoma types 1 (PH1) and 2 (PH2)] on follow-up CT 24 h to 2 weeks after treatment. We assessed functional outcome using the modified Rankin Scale 90 days after stroke onset. Ordinal logistic regression with and without adjustment for potential confounders was used to describe the association of hemorrhage volume with functional outcome. We created regression models including and excluding total lesion volume as a confounder.Results: We included 478 patients. Of these patients, 222 had HT. Median hemorrhage volume was 3.37 ml (0.80–12.6) and per HT subgroup; HI1: 0.2 (0.0–1.7), HI2: 3.2 (1.7–6.1), PH1: 6.3 (4.2–13), and PH2: 47 (19–101). Hemorrhage volume was associated with functional outcome [adjusted common odds ratio (acOR): 0.83, 95% CI: 0.73–0.95] but not anymore after adjustment for total lesion volume (acOR: 0.99, 95% CI: 0.86–1.15, per 10 ml). Hemorrhage volume in patients with PH2 was significantly associated with functional outcome after adjusting total lesion volume (acOR: 0.70, 95% CI: 0.50–0.98).Conclusion: HT volume is associated with functional outcomes in patients with acute ischemic stroke but not independent of total lesion volume. The extent of a PH2 was associated with outcome, suggesting that measuring hemorrhage volume only provides an additional benefit in the prediction of the outcome when a PH2 is present.

    وصف الملف: electronic resource

  7. 7
    دورية أكاديمية

    المصدر: Applied Sciences, Vol 10, Iss 14, p 4861 (2020)

    الوصف: The aim of this study was to develop a convolutional neural network (CNN) that automatically detects and segments intra-arterial thrombi on baseline non-contrast computed tomography (NCCT) scans. We retrospectively collected computed tomography (CT)-scans of patients with an anterior circulation large vessel occlusion (LVO) from the Multicenter Randomized Clinical Trial of Endovascular Treatment for Acute Ischemic Stroke in the Netherlands trial, both for training (n = 86) and validation (n = 43). For testing we included patients with (n = 58) and without (n = 45) an LVO from our comprehensive stroke center. Ground truth was established by consensus between two experts using both CT angiography and NCCT. We evaluated the CNN for correct identification of a thrombus, its location and thrombus segmentation and compared these with the results of a neurologist in training and expert neuroradiologist. Sensitivity of the CNN thrombus detection was 0.86, vs. 0.95 and 0.79 for the neuroradiologists. Specificity was 0.65 for the network vs. 0.58 and 0.82 for the neuroradiologists. The CNN correctly identified the location of the thrombus in 79% of the cases, compared to 81% and 77% for the neuroradiologists. The sensitivity and specificity for thrombus identification and the rate for correct thrombus location assessment by the CNN were similar to those of expert neuroradiologists.

    وصف الملف: electronic resource

  8. 8
    دورية أكاديمية

    المصدر: PLoS ONE, Vol 17, Iss 8, p e0272276 (2022)

    مصطلحات موضوعية: Medicine, Science

    الوصف: Background and objective Computed tomography perfusion (CTP) is widely used in the evaluation of acute ischemic stroke patients for endovascular thrombectomy (EVT). The stability of CTP core estimation is suboptimal and varies between software packages. We aimed to quantify the volumetric and spatial agreement between the CTP ischemic core and follow-up infarct for four ischemic core estimation approaches using syngo.via. Methods We included successfully reperfused, EVT-treated patients with baseline CTP and 24h follow-up diffusion weighted magnetic resonance imaging (DWI) (November 2017-September 2020). Data were processed with syngo.via VB40 using four core estimation approaches based on: cerebral blood volume (CBV)<1.2mL/100mL with and without smoothing filter, relative cerebral blood flow (rCBF)<30%, and rCBF<20%. The follow-up infarct was segmented on DWI. Results In 59 patients, median estimated CTP core volumes for four core estimation approaches ranged from 12-39 mL. Median 24h follow-up DWI infarct volume was 11 mL. The intraclass correlation coefficient (ICC) showed moderate-good volumetric agreement for all approaches (range 0.61-0.76). Median Dice was low for all approaches (range 0.16-0.21). CTP core overestimation >10mL occurred least frequent (14/59 [24%] patients) using the CBV-based core estimation approach with smoothing filter. Conclusions In successfully reperfused patients who underwent EVT, syngo.via CTP ischemic core estimation showed moderate volumetric and spatial agreement with the follow-up infarct on DWI. In patients with complete reperfusion after EVT, the volumetric agreement was excellent. A CTP core estimation approach based on CBV<1.2 mL/100mL with smoothing filter least often overestimated the follow-up infarct volume and is therefore preferred for clinical decision making using syngo.via.

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    المساهمون: Pediatrics, Radiology and nuclear medicine, ACS - Atherosclerosis & ischemic syndromes, Neurology, Public Health, Radiology & Nuclear Medicine, Neurosurgery, Erasmus MC other, General Practice, Radiology and Nuclear Medicine, ANS - Cellular & Molecular Mechanisms, Biomedical Engineering and Physics, Graduate School, ANS - Brain Imaging, ANS - Neurovascular Disorders, ACS - Microcirculation, ​Basic and Translational Research and Imaging Methodology Development in Groningen (BRIDGE), Damage and Repair in Cancer Development and Cancer Treatment (DARE), MUMC+: MA AIOS Neurologie (9), RS: Carim - B06 Imaging, RS: Carim - B05 Cerebral small vessel disease, MUMC+: MA Niet Med Staf Neurologie (9), Beeldvorming, MUMC+: DA BV Research (9), MUMC+: DA BV AIOS Radiologie (8), MUMC+: DA BV AIOS Nucleaire Geneeskunde (8), MUMC+: DA BV Medisch Specialisten Radiologie (9), RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, MUMC+: MA Med Staf Spec Neurologie (9), MUMC+: MA Neurologie (3), MUMC+: Hersen en Zenuw Centrum (3)

    المصدر: The Lancet (London), 401, 10385, pp. 1371-1380
    The Lancet, 401(10385), 1371-1380. Elsevier Limited
    The Lancet, 401(10385), 1371-1380. Elsevier Ltd.
    The Lancet, 401(10385), 1371-1380. ELSEVIER SCIENCE INC
    The Lancet (London), 401, 1371-1380
    MR CLEAN-LATE investigators 2023, ' Endovascular treatment versus no endovascular treatment after 6–24 h in patients with ischaemic stroke and collateral flow on CT angiography (MR CLEAN-LATE) in the Netherlands : a multicentre, open-label, blinded-endpoint, randomised, controlled, phase 3 trial ', The Lancet, vol. 401, no. 10385, pp. 1371-1380 . https://doi.org/10.1016/S0140-6736Test(23)00575-5
    Lancet, 401(10385), 1371-1380. Elsevier Science

    الوصف: BACKGROUND: Endovascular treatment for anterior circulation ischaemic stroke is effective and safe within a 6 h window. MR CLEAN-LATE aimed to assess efficacy and safety of endovascular treatment for patients treated in the late window (6-24 h from symptom onset or last seen well) selected on the basis of the presence of collateral flow on CT angiography (CTA).METHODS: MR CLEAN-LATE was a multicentre, open-label, blinded-endpoint, randomised, controlled, phase 3 trial done in 18 stroke intervention centres in the Netherlands. Patients aged 18 years or older with ischaemic stroke, presenting in the late window with an anterior circulation large-vessel occlusion and collateral flow on CTA, and a neurological deficit score of at least 2 on the National Institutes of Health Stroke Scale were included. Patients who were eligible for late-window endovascular treatment were treated according to national guidelines (based on clinical and perfusion imaging criteria derived from the DAWN and DEFUSE-3 trials) and excluded from MR CLEAN-LATE enrolment. Patients were randomly assigned (1:1) to receive endovascular treatment or no endovascular treatment (control), in addition to best medical treatment. Randomisation was web based, with block sizes ranging from eight to 20, and stratified by centre. The primary outcome was the modified Rankin Scale (mRS) score at 90 days after randomisation. Safety outcomes included all-cause mortality at 90 days after randomisation and symptomatic intracranial haemorrhage. All randomly assigned patients who provided deferred consent or died before consent could be obtained comprised the modified intention-to-treat population, in which the primary and safety outcomes were assessed. Analyses were adjusted for predefined confounders. Treatment effect was estimated with ordinal logistic regression and reported as an adjusted common odds ratio (OR) with a 95% CI. This trial was registered with the ISRCTN, ISRCTN19922220.FINDINGS: Between Feb 2, 2018, and Jan 27, 2022, 535 patients were randomly assigned, and 502 (94%) patients provided deferred consent or died before consent was obtained (255 in the endovascular treatment group and 247 in the control group; 261 [52%] females). The median mRS score at 90 days was lower in the endovascular treatment group than in the control group (3 [IQR 2-5] vs 4 [2-6]), and we observed a shift towards better outcomes on the mRS for the endovascular treatment group (adjusted common OR 1·67 [95% CI 1·20-2·32]). All-cause mortality did not differ significantly between groups (62 [24%] of 255 patients vs 74 [30%] of 247 patients; adjusted OR 0·72 [95% CI 0·44-1·18]). Symptomatic intracranial haemorrhage occurred more often in the endovascular treatment group than in the control group (17 [7%] vs four [2%]; adjusted OR 4·59 [95% CI 1·49-14·10]).INTERPRETATION: In this study, endovascular treatment was efficacious and safe for patients with ischaemic stroke caused by an anterior circulation large-vessel occlusion who presented 6-24 h from onset or last seen well, and who were selected on the basis of the presence of collateral flow on CTA. Selection of patients for endovascular treatment in the late window could be primarily based on the presence of collateral flow.FUNDING: Collaboration for New Treatments of Acute Stroke consortium, Dutch Heart Foundation, Stryker, Medtronic, Cerenovus, Top Sector Life Sciences & Health, and the Netherlands Brain Foundation.

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    المؤلفون: Sophie A van den Berg, Simone M Uniken Venema, Hendrik Reinink, Jeannette Hofmeijer, Wouter J Schonewille, Irene Miedema, Puck S S Fransen, D Martijn O Pruissen, Theodora W M Raaijmakers, Gert W van Dijk, Frank-Erik de Leeuw, Jorine A van Vliet, Vincent I H Kwa, Henk Kerkhoff, Alex van 't Net, Rene Boomars, Arjen Siegers, Tycho Lok, Klaartje Caminada, Laura M Esteve Cuevas, Marieke C Visser, Casper P Zwetsloot, Jooske M F Boomsma, Mirjam H Schipper, Roeland P J van Eijkelenburg, Olvert A Berkhemer, Daan Nieboer, Hester F Lingsma, Bart J Emmer, Robert J van Oostenbrugge, Aad van der Lugt, Yvo B W E M Roos, Charles B L M Majoie, Diederik W J Dippel, Paul J Nederkoorn, H Bart van der Worp, Ayla van Ahee, Frank Visseren, Patricia Halkes, Ruben van Eijk, Michelle Simons, Wilma Pellikaan, Wilma Van Wijngaarden, Eva Ponjee, Petra Geijtenbeek, Ton Arts, Elles Zock, Wilma Oudshoorn, Frans Steenwinkel, Hamdia Samim, Mark van Zandwijk, Lisette Vrielink, Peter Jan Mulder, Aico Gerritsen, Jim Ijzermans, Marjan Kooijman, Oscar Francissen, Rick van Nuland, Wim van Zwam, Linda Jacobi, Rene van den Berg, Ludo Beenen, Adriaan van Es, Pieter-Jan van Doormaal, Geert Lycklama a Nijeholt, Ido van den Wijngaard, Albert Yoo, Lonneke Yo, Jasper Martens, Bas Hammer, Stefan Roosendaal, Anton Meijer, Menno Krietemeijer, Reinoud Bokkers, Anouk van der Hoorn, Dick Gerrits, Jonathan Coutinho, Ben Jansen, Sanne Manschot, Peter Koudstaal, Koos Keizer, Vicky Chalos, Adriaan Versteeg, Lennard Wolff, Henk van Voorst, Matthijs van der Sluijs, Arnolt-Jan Hoving, Kilian Treurniet, Natalie LeCouffe, Rob van de Graaf, Robert-Jan Goldhoorn, Wouter Hinseveld, Anne Pirson, Lotte Sondag, Manon Kappelhof, Manon Tolhuisen, Josje Brouwer, Wouter van der Steen, Leon Rinkel, Agnetha Bruggeman, Rita Sprengers, Martin Sterrenberg, Sabrina Verheesen, Leontien Heiligers, Yvonne Martens, Naziha El Ghannouti, Miranda Slotboom

    المساهمون: MUMC+: MA Neurologie (3), MUMC+: Hersen en Zenuw Centrum (3), Klinische Neurowetenschappen, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, RS: Carim - B05 Cerebral small vessel disease, Graduate School, ACS - Atherosclerosis & ischemic syndromes, ANS - Neurovascular Disorders, Neurology, Radiology and Nuclear Medicine, ANS - Cellular & Molecular Mechanisms, ACS - Microcirculation, ACS - Pulmonary hypertension & thrombosis, Biomedical Engineering and Physics, ANS - Brain Imaging, ANS - Compulsivity, Impulsivity & Attention, Radiology & Nuclear Medicine, Public Health, Radiology and nuclear medicine, Pediatrics, ​Basic and Translational Research and Imaging Methodology Development in Groningen (BRIDGE), Damage and Repair in Cancer Development and Cancer Treatment (DARE), TechMed Centre, Clinical Neurophysiology

    المصدر: Lancet Neurology, 21(11), 971-981. Elsevier Science
    MR ASAP Investigators 2022, ' Prehospital transdermal glyceryl trinitrate in patients with presumed acute stroke (MR ASAP) : an ambulance-based, multicentre, randomised, open-label, blinded endpoint, phase 3 trial ', The Lancet Neurology, vol. 21, no. 11, pp. 971-981 . https://doi.org/10.1016/S1474-4422Test(22)00333-7
    The Lancet Neurology, 21(11), 971-981. Lancet Publishing Group
    Lancet Neurology, 21, 971-981
    Lancet Neurology, 21, 11, pp. 971-981
    Lancet Neurology, 21(11), 971-981. ELSEVIER SCIENCE INC

    الوصف: Contains fulltext : 287508.pdf (Publisher’s version ) (Closed access) BACKGROUND: Pooled analyses of previous randomised studies have suggested that very early treatment with glyceryl trinitrate (also known as nitroglycerin) improves functional outcome in patients with acute ischaemic stroke or intracerebral haemorrhage, but this finding was not confirmed in a more recent trial (RIGHT-2). We aimed to assess whether patients with presumed acute stroke benefit from glyceryl tr initrate started within 3 h after symptom onset. METHODS: MR ASAP was a phase 3, randomised, open-label, blinded endpoint trial done at six ambulance services serving 18 hospitals in the Netherlands. Eligible participants (aged ≥18 years) had a probable diagnosis of acute stroke (as assessed by a paramedic), a face-arm-speech-time test score of 2 or 3, systolic blood pressure of at least 140 mm Hg, and could start treatment within 3 h of symptom onset. Participants were randomly assigned (1:1) by ambulance personnel, using a secure web-based electronic application with random block sizes stratified by ambulance service, to receive either transdermal glyceryl trinitrate 5 mg/day for 24 h plus standard care (glyceryl trinitrate group) or to standard care alone (control group) in the prehospital setting. Informed consent was deferred until after arrival at the hospital. The primary outcome was functional outcome assessed with the modified Rankin Scale (mRS) at 90 days. Safety outcomes included death within 7 days, death within 90 days, and serious adverse events. Analyses were based on modified intention to treat, and treatment effects were expressed as odds ratios (ORs) or common ORs, with adjustment for baseline prognostic factors. We separately analysed the total population and the target population (ie, patients with intracerebral haemorrhage, ischaemic stroke, or transient ischaemic attack). The target sample size was 1400 patients. The trial is registered as ISRCTN99503308. FINDINGS: On June 24, 2021, the MR ASAP trial was prematurely terminated on the advice of the data and safety monitoring board, with recruitment stopped because of safety concerns in patients with intracerebral haemorrhage. Between April 4, 2018, and Feb 12, 2021, 380 patients were randomly allocated to a study group. 325 provided informed consent or died before consent could be obtained, of whom 170 were assigned to the glyceryl trinitrate group and 155 to the control group. These patients were included in the total population. 201 patients (62%) had ischaemic stroke, 34 (10%) transient ischaemic attack, 56 (17%) intracerebral haemorrhage, and 34 (10%) a stroke-mimicking condition. In the total population (n=325), the median mRS score at 90 days was 2 (IQR 1-4) in both the glyceryl trinitrate and control groups (adjusted common OR 0·97 [95% CI 0·65-1·47]). In the target population (n=291), the 90-day mRS score was 2 (2-4) in the glyceryl trinitrate group and 3 (1-4) in the control group (0·92 [0·59-1·43]). In the total population, there were no differences between the two study groups with respect to death within 90 days (adjusted OR 1·07 [0·53-2·14]) or serious adverse events (unadjusted OR 1·23 [0·76-1·99]). In patients with intracerebral haemorrhage, 12 (34%) of 35 patients allocated to glyceryl trinitrate versus two (10%) of 21 allocated to the control group died within 7 days (adjusted OR 5·91 [0·78-44·81]); death within 90 days occurred in 16 (46%) of 35 in the glyceryl trinitrate group and 11 (55%) of 20 in the control group (adjusted OR 0·87 [0·18-4·17]). INTERPRETATION: We found no sign of benefit of transdermal glyceryl trinitrate started within 3 h of symptom onset in the prehospital setting in patients with presumed acute stroke. The signal of potential early harm of glyceryl trinitrate in patients with intracerebral haemorrhage suggests that glyceryl trinitrate should be avoided in this setting. FUNDING: The Collaboration for New Treatments of Acute Stroke consortium, the Brain Foundation Netherlands, the Ministry of Economic Affairs, Stryker, Medtronic, Cerenovus, and the Dutch Heart Foundation.

    وصف الملف: application/pdf