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  • Ebinger, Martin  (36)
  • Lemmens, Robin  (36)
  • Nighoghossian, Norbert  (36)
  • 1
    Online Resource
    Online Resource
    Intravenous alteplase for stroke with unknown time of onset guided by advanced imaging: systematic review and meta-analysis of individual patient data
    Elsevier BV ; 2020
    In:  The Lancet Vol. 396, No. 10262 ( 2020-11), p. 1574-1584
    Details
    In: The Lancet, Elsevier BV, Vol. 396, No. 10262 ( 2020-11), p. 1574-1584
    Type of Medium: Online Resource
    ISSN: 0140-6736
    URL: Article
    DOI: 10.1016/S0140-6736(20)32163-2
    RVK:
    XA 10000
    Language: English
    Publisher: Elsevier BV
    Publication Date: 2020
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    SSG: 5,21
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  • 2
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    Game-theoretical mapping of fundamental brain functions based on lesion deficits in acute stroke
    Oxford University Press (OUP) ; 2021
    In:  Brain Communications Vol. 3, No. 3 ( 2021-07-01)
    Details
    In: Brain Communications, Oxford University Press (OUP), Vol. 3, No. 3 ( 2021-07-01)
    Abstract: Lesion analysis is a fundamental and classical approach for inferring the causal contributions of brain regions to brain function. However, many studies have been limited by the shortcomings of methodology or clinical data. Aiming to overcome these limitations, we here use an objective multivariate approach based on game theory, Multi-perturbation Shapley value Analysis, in conjunction with data from a large cohort of 394 acute stroke patients, to derive causal contributions of brain regions to four principal functional components of the widely used National Institutes of Health Stroke Score measure. The analysis was based on a high-resolution parcellation of the brain into 294 grey and white matter regions. Through initial lesion symptom mapping for identifying all potential candidate regions and repeated iterations of the game-theoretical approach to remove non-significant contributions, the analysis derived the smallest sets of regions contributing to each of the four principal functional components as well as functional interactions among the regions. Specifically, the factor ‘language and consciousness’ was related to contributions of cortical regions in the left hemisphere, including the prefrontal gyrus, the middle frontal gyrus, the ventromedial putamen and the inferior frontal gyrus. Right and left motor functions were associated with contributions of the left and right dorsolateral putamen and the posterior limb of the internal capsule, correspondingly. Moreover, the superior corona radiata and the paracentral lobe of the right hemisphere as well as the right caudal area 23 of the cingulate gyrus were mainly related to left motor function, while the prefrontal gyrus, the external capsule and the sagittal stratum fasciculi of the left hemisphere contributed to right motor function. Our approach demonstrates a practically feasible strategy for applying an objective lesion inference method to a high-resolution map of the human brain and distilling a small, characteristic set of grey and white matter structures contributing to fundamental brain functions. In addition, we present novel findings of synergistic interactions between brain regions that provide insight into the functional organization of brain networks.
    Type of Medium: Online Resource
    ISSN: 2632-1297
    URL: Article
    DOI: 10.1093/braincomms/fcab204
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2021
    detail.hit.zdb_id: 3020013-1
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  • 3
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    Serious Adverse Events and Their Impact on Functional Outcome in Acute Ischemic Stroke in the WAKE-UP Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2021
    In:  Stroke Vol. 52, No. 12 ( 2021-12), p. 3768-3776
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 52, No. 12 ( 2021-12), p. 3768-3776
    Abstract: During the first days and weeks after an acute ischemic stroke, patients are prone to complications that can influence further treatment, recovery, and functional outcome. In clinical trials, severe complications are recorded as serious adverse events (SAE). We analyzed the effect of SAE on functional outcome and predictors of SAE in the randomized controlled WAKE-UP trial (Efficacy and Safety of MRI-Based Thrombolysis in Wake-Up Stroke). Methods: We performed a post hoc analysis of WAKE-UP, a multicenter, randomized, placebo-controlled clinical trial of magnetic resonance imaging-guided intravenous thrombolysis with alteplase in patients with acute ischemic stroke and unknown time of onset. Functional outcome was assessed by the modified Rankin Scale 90 days after the stroke. SAE were reported to a central safety desk and recorded and categorized by organ system using Medical Dictionary for Regulatory Activities terminology. We used logistic regression analysis to determine the effect of SAE on functional outcome and linear multiple regression analysis to identify baseline predictors of SAE. Results: Among 503 patients randomized, 199 SAE were reported for n=110 (22%) patients. Of those patients who did suffer a SAE, 20 (10%) had a fatal outcome. Patients suffering from at least one SAE had a lower odds of reaching a favorable outcome (modified Rankin Scale score of 0–1) at 90 days (adjusted odds ratio, 0.36 [95% CI, 0.21–0.61], P 〈 0.001). Higher age ( P =0.04) and male sex ( P =0.01) were predictors for the occurrence of SAE. Conclusions: SAEs were observed in about one in 5 patients, were more frequent in elderly and male patients and were associated with worse functional outcome. These results may help to assess the risk of SAE in future stroke trials and create awareness for severe complications after stroke in clinical practice. Registration: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01525290. URL: https://eudract.ema.europa.eu ; Unique identifier: 2011-005906-32.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.120.033425
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2021
    detail.hit.zdb_id: 80381-9
    detail.hit.zdb_id: 1467823-8
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  • 4
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    Abstract WP86: MRI-Guided Mismatch Imaging to Identify Patients for Thrombolysis in the Unknown Time Window: Insights From the WAKE-UP Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2020
    In:  Stroke Vol. 51, No. Suppl_1 ( 2020-02)
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 51, No. Suppl_1 ( 2020-02)
    Abstract: Background: Two imaging paradigms, the diffusion-weighted imaging (DWI) - fluid attenuated inversion recovery (FLAIR) and perfusion-weighted imaging (PWI) - DWI mismatch, used in the Efficacy and Safety of MRI-Based Thrombolysis in Wake-Up Stroke (WAKE-UP) and Extending the Time for Thrombolysis in Emergency Neurological Deficits (EXTEND) trial respectively, can identify patients eligible for thrombolysis if stroke onset time is unknown. Objectives: We explored presence and influence of the PWI-DWI mismatch on outcome in WAKE-UP. Methods: We included patients screened for DWI-FLAIR mismatch in WAKE-UP who also underwent PWI. We defined PWI-DWI mismatch according to EXTEND as core 〈 70 ml, mismatch ratio 〉 1.2 and mismatch volume 〉 10 ml. Primary efficacy end point was favorable outcome defined as modified Rankin Scale score of 0-1, adjusted for age and symptom severity. Results: The analysis included 343 screened patients of which 162 were randomized and treated. Of 343 screened patients, 162 had a DWI-FLAIR mismatch, 80 had a PWI-DWI mismatch and of those, 36 had both mismatches. Proportions of PWI-DWI mismatch did not differ in those with (22%, 36/162) vs without (24%, 44/181) DWI-FLAIR mismatch (p=0.74). PWI-DWI mismatch status did not modify treatment effect of thrombolysis (p for interaction=.68). In patients with both DWI-FLAIR and PWI-DWI mismatch, favorable outcome was present in 52% of those treated with alteplase (11/21) vs 38% (5/13) in those receiving placebo (adjusted OR 2.02; 95% CI 0.44-9.24, p=0.36). Selection based on the presence of the DWI-FLAIR mismatch identified more thrombolysis eligible patients (47%; 95% CI 42%-53%) compared to the PWI-DWI mismatch (23%; 95% CI 19%-28%, p 〈 .0001). Screening for either one of the mismatch profiles resulted in a yield of 60% (95% CI 55%-65%) candidates for thrombolysis. Conclusion: We did not identify an association between the DWI-FLAIR and PWI-DWI mismatch. PWI-DWI mismatch status did not modify treatment effect in patients with DWI-FLAIR mismatch, but the analysis was underpowered. Screening for the presence of either one of the mismatch profiles with MRI seems the most inclusive approach to identify patients who can still benefit from thrombolysis in the unknown time window after stroke onset.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/str.51.suppl_1.WP86
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2020
    detail.hit.zdb_id: 80381-9
    detail.hit.zdb_id: 1467823-8
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  • 5
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    Data_Sheet_1.DOCX
    Frontiers Media SA ; 2022
    In:  Frontiers in Neurology Vol. 13 ( 2022-6-13)
    Details
    In: Frontiers in Neurology, Frontiers Media SA, Vol. 13 ( 2022-6-13)
    Abstract: Higher white blood cell (WBC) count is associated with poor functional outcome in acute ischemic stroke (AIS). However, little is known about whether the association is modified by treatment with intravenous alteplase. Methods WAKE-UP was a randomized controlled trial of the efficacy and safety of magnetic resonance imaging [MRI]-based thrombolysis in unknown onset stroke. WBC count was measured on admission and again at 22–36 h after randomization to treatment (follow-up). Favorable outcome was defined by a score of 0 or 1 on the modified Rankin scale (mRS) 90 days after stroke. Further outcome were stroke volume and any hemorrhagic transformation (HT) that were assessed on follow-up CT or MRI. Multiple logistic regression analysis was used to assess the association between outcome and WBC count and treatment group. Results Of 503 randomized patients, WBC count and baseline parameters were available in 437 patients (μ = 64.7 years, 35.2% women) on admission and 355 patients (μ = 65.1 years, 34.1% women) on follow-up. Median WBC count on admission was 7.6 × 10 9 /L (interquartile range, IQR, 6.1–9.4 × 10 9 /L) and 8.2 × 10 9 /L (IQR, 6.7–9.7 × 10 9 /L) on follow-up. Higher WBC count both on admission and follow-up was associated with lower odds of favorable outcome, adjusted for age, National Institutes of Health (NIH) Stroke Scale Score, temperature, and treatment (alteplase vs. placebo, adjusted odds ratio, aOR 0.85, 95% confidence interval [CI] 0.78–0.94 and aOR 0.88, 95% CI 0.79–0.97). No interaction between WBC count and treatment group was observed ( p = 0.11). Furthermore, WBC count on admission and follow-up was significantly associated with HT (aOR 1.14, 95% CI 1.05–1.24 and aOR 1.13, 95% CI 1.00–1.26). Finally, WBC count on follow-up was associated with larger stroke volume (aOR 2.57, 95% CI 1.08–6.07). Conclusion Higher WBC count is associated with unfavorable outcome, an increased risk of HT, and larger stroke volume, independent of treatment with alteplase. Whether immunomodulatory manipulation of WBC count improves stroke outcome needs to be tested. Trial Registration ClinicalTrials.gov Identifier: NCT01525290.
    Type of Medium: Online Resource
    ISSN: 1664-2295
    URL: Article
    URL: Article
    DOI: 10.3389/fneur.2022.877367
    DOI: 10.3389/fneur.2022.877367.s001
    Language: Unknown
    Publisher: Frontiers Media SA
    Publication Date: 2022
    detail.hit.zdb_id: 2564214-5
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  • 6
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    Clinical Characteristics and Outcome of Patients with Lacunar Infarcts and Concurrent Embolic Ischemic Lesions
    Springer Science and Business Media LLC ; 2020
    In:  Clinical Neuroradiology Vol. 30, No. 3 ( 2020-09), p. 511-516
    Details
    In: Clinical Neuroradiology, Springer Science and Business Media LLC, Vol. 30, No. 3 ( 2020-09), p. 511-516
    Type of Medium: Online Resource
    ISSN: 1869-1439 , 1869-1447
    URL: Article
    DOI: 10.1007/s00062-019-00800-5
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2020
    detail.hit.zdb_id: 2234662-4
    detail.hit.zdb_id: 2232347-8
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  • 7
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    Sex differences in imaging and clinical characteristics of patients from the WAKE‐UP trial
    Wiley ; 2023
    In:  European Journal of Neurology Vol. 30, No. 3 ( 2023-03), p. 641-647
    Details
    In: European Journal of Neurology, Wiley, Vol. 30, No. 3 ( 2023-03), p. 641-647
    Abstract: Sex‐based differences in acute ischemic stroke are a well‐known phenomenon. We aimed to explore these differences between women and men in the Efficacy and Safety of MRI‐Based Thrombolysis in Wake‐Up Stroke (WAKE‐UP) trial. Methods We compared baseline demographic and imaging characteristics (visual fluid‐attenuated inversion recovery [FLAIR] positivity, relative FLAIR signal intensity, collateral status) between women and men in all screened patients. In randomized patients (i.e., those with diffusion‐weighted imaging (DWI)–FLAIR mismatch), we evaluated a modifying role of sex on the treatment effect of alteplase in multivariable logistic regression, with treatment adjusted for National Institute of Health Stroke Scale (NIHSS) score and age. Dependent variables were modified Rankin Scale (mRS) score of 0–1 at 90 days and distribution of mRS scores at 90 days. Results Of 1362 screened patients, 529 (38.8%) were women. Women were older than men, had higher baseline NIHSS scores and smoked less frequently. FLAIR positivity of the DWI lesion was equally present in women (174/529, 33.1%) and men (273/833, 33.3%; p  = 1.00) and other imaging variables also did not differ between the sexes. In a total of 503 randomized patients, of whom 178 were women (35.4%), sex did not modify the treatment effect of alteplase on mRS score 0–1 or on the total distribution of mRS scores. Conclusion As in many other stroke trials, more men than women were included in the WAKE‐UP trial, but the presence of a visual DWI–FLAIR mismatch and the relative FLAIR signal intensity did not differ between the sexes. The treatment effect of alteplase was not modified by sex.
    Type of Medium: Online Resource
    ISSN: 1351-5101 , 1468-1331
    URL: Issue
    URL: Article
    DOI: 10.1111/ene.v30.3
    DOI: 10.1111/ene.15629
    Language: English
    Publisher: Wiley
    Publication Date: 2023
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    detail.hit.zdb_id: 1280785-0
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  • 8
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    Intravenous Thrombolysis in Patients With White Matter Hyperintensities in the WAKE-UP Trial
    Ovid Technologies (Wolters Kluwer Health) ; 2023
    In:  Stroke Vol. 54, No. 7 ( 2023-07), p. 1718-1725
    Details
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 54, No. 7 ( 2023-07), p. 1718-1725
    Abstract: White matter hyperintensities of presumed vascular origin (WMH) are the most prominent imaging feature of cerebral small vessel disease (cSVD). Previous studies suggest a link between cSVD burden and intracerebral hemorrhage and worse functional outcome after thrombolysis in acute ischemic stroke. We aimed to determine the impact of WMH burden on efficacy and safety of thrombolysis in the MRI-based randomized controlled WAKE-UP trial of intravenous alteplase in unknown onset stroke. METHODS: The design of this post hoc study was an observational cohort design of a secondary analysis of a randomized trial. WMH volume was quantified on baseline fluid-attenuated inversion recovery images of patients randomized to either alteplase or placebo in the WAKE-UP trial. Excellent outcome was defined as score of 0-1 on the modified Rankin Scale after 90 days. Hemorrhagic transformation was assessed on follow-up imaging 24-36 hours after randomization. Treatment effect and safety were analyzed by fitting multivariable logistic regression models. RESULTS: Quality of scans was sufficient in 441 of 503 randomized patients to delineate WMH. Median age was 68 years, 151 patients were female, and 222 patients were assigned to receive alteplase. Median WMH volume was 11.4 mL. Independent from treatment, WMH burden was statistically significantly associated with worse functional outcome (odds ratio, 0.72 [95% CI, 0.57–0.92] ), but not with higher chances of any hemorrhagic transformation (odds ratio, 0.78 [95% CI, 0.60–1.01]). There was no interaction of WMH burden and treatment group for the likelihood of excellent outcome ( P =0.443) or any hemorrhagic transformation ( P =0.151). In a subgroup of 166 patients with severe WMH, intravenous thrombolysis was associated with higher odds of excellent outcome (odds ratio, 2.40 [95% CI, 1.19–4.84]) with no significant increase in the rate of hemorrhagic transformation (odds ratio, 1.96 [95% CI, 0.80–4.81] ). CONCLUSIONS: Although WMH burden is associated with worse functional outcome, there is no association with treatment effect or safety of intravenous thrombolysis in patients with ischemic stroke of unknown onset. REGISTRATION: URL: https://www.clinicaltrials.gov ; Unique identifier: NCT01525290.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    URL: Article
    DOI: 10.1161/STROKEAHA.122.040247
    RVK:
    XA 10000
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
    detail.hit.zdb_id: 80381-9
    detail.hit.zdb_id: 1467823-8
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  • 9
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    Clinical characteristics of unknown symptom onset stroke patients with and without diffusion-weighted imaging and fluid-attenuated inversion recovery mismatch
    SAGE Publications ; 2018
    In:  International Journal of Stroke Vol. 13, No. 1 ( 2018-01), p. 66-73
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 13, No. 1 ( 2018-01), p. 66-73
    Abstract: Diffusion-weighted imaging (DWI) and fluid-attenuated inversion recovery (FLAIR) mismatch was suggested to identify stroke patients with unknown time of symptom onset likely to be within the time window for thrombolysis. Aims We aimed to study clinical characteristics associated with DWI-FLAIR mismatch in patients with unknown onset stroke. Methods We analyzed baseline MRI and clinical data from patients with acute ischemic stroke proven by DWI from WAKE-UP, an investigator-initiated, randomized, placebo-controlled trial of MRI-based thrombolysis in stroke patients with unknown time of symptom onset. Clinical characteristics were compared between patients with and without DWI-FLAIR mismatch. Results Of 699 patients included, 418 (59.8%) presented with DWI-FLAIR mismatch. A shorter delay between last seen well and symptom recognition (p = 0.0063), a shorter delay between symptom recognition and arrival at hospital (p = 0.0025), and history of atrial fibrillation (p = 0.19) were predictors of DWI-FLAIR mismatch in multivariate analysis. All other characteristics were comparable between groups. Conclusions There are only minor differences in measured clinical characteristics between unknown symptom onset stroke patients with and without DWI-FLAIR mismatch. DWI-FLAIR mismatch as an indicator of stroke onset within 4.5 h shows no relevant association with commonly collected clinical characteristics of stroke patients. Clinical Trial Registration URL: http://www.clinicaltrials.gov . Unique identifier: NCT01525290; URL: https://www.clinicaltrialsregister.eu . Unique identifier: 2011-005906-32.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493017706245
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2018
    detail.hit.zdb_id: 2303728-3
    detail.hit.zdb_id: 2211666-7
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  • 10
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    24-hour blood pressure variability and treatment effect of intravenous alteplase in acute ischaemic stroke
    SAGE Publications ; 2021
    In:  European Stroke Journal Vol. 6, No. 2 ( 2021-06), p. 168-175
    Details
    In: European Stroke Journal, SAGE Publications, Vol. 6, No. 2 ( 2021-06), p. 168-175
    Abstract: To assess the association between 24 h blood pressure variability (BPV) on functional outcome and treatment effect of intravenous alteplase in acute ischaemic stroke. Patients and methods In all patients with acute ischaemic stroke of unknown onset randomised in the WAKE-UP (Efficacy and Safety of magnetic resonance imaging [MRI]-based Thrombolysis in Wake-Up Stroke) trial, bloo d pressure (BP) was measured before randomisation and after initiation of treatment at regular intervals up to 24 hours. Individual BPV was measured by coefficient of variation (CV) of all BP values. Primary outcome measure was favourable outcome defined by a modified Rankin Scale (mRS) score 0 or 1 at 90 days after stroke. Results BP measurements were available for 498 of 503 patients randomised (177 women [35.5%], mean age [SD] of 65.2 [11.5] years). Systolic BPV was not associated with the treatment effect of thrombolysis (test for interaction, p = 0.46). The adjusted odds ratio (aOR) for favourable outcome with alteplase, adjusted for age, stroke severity and baseline BP on admission, did not show an association across the quintiles of increasing systolic BPV with an aOR 1.89 (95% confidence interval [CI] , 0.76–4.70) in the lowest quintile to aOR 1.05 (95% CI, 0.43–2.56) in the highest quintile. Higher mean systolic BP was associated with a smaller treatment effect of thrombolysis with a significant interaction (p = 0.033). The aOR for favourable outcome with alteplase decreased with quintiles of increasing mean systolic BP from aOR 3.16 (95% CI, 1.26–7.93) in the lowest quintile to aOR 0.84 (95% CI, 0.34–2.10) in in the highest quintile. Conclusions There was a significant interaction between mean systolic BP and treatment effect of thrombolysis with higher mean systolic BP being associated with poorer outcome. BPV was not associated with outcome after thrombolysis. ClinicalTrials.gov identifier NCT01525290.
    Type of Medium: Online Resource
    ISSN: 2396-9873 , 2396-9881
    URL: Article
    DOI: 10.1177/23969873211014758
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2021
    detail.hit.zdb_id: 2851287-X
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