{"title":"Where are we going for the treatment in ischaemic stroke: a comprehensive study of investigator-sponsored randomised controlled trials, 1990-2024.","authors":"Xinya Li, Xue Xia, Meng Gao, Ruobing Tian, Xue Tian, Manqi Zheng, Anxin Wang","doi":"10.1136/svn-2025-004027","DOIUrl":"https://doi.org/10.1136/svn-2025-004027","url":null,"abstract":"<p><strong>Background: </strong>Until recently, a comprehensive understanding of the current development status and emerging trends of investigator-sponsored randomised controlled trials (RCTs) for the treatment of ischaemic stroke (IS) on a global scale remains elusive, making it unclear where the research and innovation in the field are going.</p><p><strong>Methods: </strong>Following the design, registration, enrolment and publication (DREP) cycle, we conducted an observational study of investigator-sponsored RCTs enrolling patients with IS for therapeutic purposes using the International Clinical Trial Registry Platform. We analysed cumulative publication rates since registration and enrolment and explored the association of potential factors with publication status.</p><p><strong>Results: </strong>A total of 1518 trials were included. The number of registered, enrolment-commenced, published RCTs increased from 1990 to 2024 (p<0.001, for all). Of these, 66.5% were registered prior to their enrolment with the first subject. Among 435 trials that ended and were registered 5 years ago, 189 (43.4%) have been published. Multivariable Cox regression analysis revealed that endovascular therapy or surgery as intervention (compared with traditional medicine) (HR (95% CI), 2.02 (1.06 to 3.87)) was associated with trial publication. Also, there existed a positive association between target sample size and publication, when the sample size surpassed 274. In addition, the most frequent cause of the termination and withdrawal in trials is the difficulty in enrolment.</p><p><strong>Conclusion: </strong>Since 1990 to the present, investigator-sponsored RCTs of IS treatment have seen a significant increase worldwide. Nevertheless, a multitude of impediments in the DREP cycle still persists that necessitate resolution and enhancement. There is a pressing need for addressing issues such as retrospective registration, premature termination of enrolment and suppression of study results, to further expand the reach of research improvements to a wider patient community.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144754935","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Rationale and design of Low-Frequency REpetitive TRanscranial Magnetic Stimulation Combined with Endovascular Treatment in ACute Ischaemic StrokE (RETRACE II): a randomised double-blind controlled multicentre phase II pilot study.","authors":"Lingling Ding, Wenjie Wang, Tingyu Yi, Gaocai Zhang, Xinsheng Han, Wenhuo Chen, Hao Wang, Yongjun Wang, Zixiao Li","doi":"10.1136/svn-2025-004331","DOIUrl":"https://doi.org/10.1136/svn-2025-004331","url":null,"abstract":"<p><strong>Background: </strong>While endovascular therapy (EVT) remains the primary treatment for acute ischaemic stroke (AIS) management, persistent functional deficits in patients with successful recanalisation underscore the necessity for complementary neuroprotective strategies.</p><p><strong>Aim: </strong>To investigate the safety and efficacy of low-frequency repetitive transcranial magnetic stimulation (LF-rTMS) as a potential adjunctive neuroprotective intervention following EVT in AIS patients.</p><p><strong>Design: </strong>The Low-Frequency REpetitive TRanscranial Magnetic Stimulation Combined with Endovascular Treatment in ACute Ischaemic StrokE (RETRACE-II) trial is a phase II, multicentre, prospective, randomised, double-blind, sham-controlled pilot study. 60 successfully recanalised AIS patients with anterior circulation occlusion were equally randomised (1:1) to active LF-rTMS or sham intervention. The intervention involved administration of 1200-pulse 1-Hz LF-rTMS sessions (two times per day for 3 consecutive days) targeting the ipsilesional primary motor cortex (M1), initiated within 24 hours of symptom onset. Sham procedures maintained equivalent positioning with deactivated magnetic output. Standardised protocol assessments were conducted at 3-day (postintervention), 7-day and 90-day follow-ups.</p><p><strong>Study outcomes: </strong>The primary efficacy endpoint was the proportion of early neurological recovery (defined as a reduction of ≥4 points on the National Institutes of Health Stroke Scale (NIHSS) or achieving a score of 0-1) at 3 days. Secondary outcomes included ischaemic penumbral salvage volume ratio, final infarct volume measured by brain MRI at 7 days, and modified Rankin Scale score at 90 days. Safety outcomes encompassed symptomatic intracranial haemorrhage, neurological deterioration (≥4-point increase in NIHSS score) and all-cause mortality through 90-day follow-up.</p><p><strong>Discussion: </strong>RETRACE-II establishes methodological rigour for evaluating neuromodulation therapies during the hyperacute stroke phase, with findings expected to inform future trials and advance combination therapy paradigms in cerebrovascular neuroprotection.</p><p><strong>Trial registration number: </strong>NCT06064747.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":4.9,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144734443","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Functional outcomes of minimally invasive surgery treatment for patients with small supratentorial spontaneous intracerebral haematoma less than 30 mL: a propensity score matching study.","authors":"Hanyu Sun, Xinqun Luo, Zhang Guo, Lingyun Zhuo, Dekui Cheng, Zhuyu Gao, Qiu He, Zheng Yan, Dezhi Kang, Wenhua Fang, Fuxin Lin","doi":"10.1136/svn-2024-003893","DOIUrl":"10.1136/svn-2024-003893","url":null,"abstract":"<p><strong>Background: </strong>This study investigated the efficacy of frameless robot-assisted stereotactic aspiration coupled with catheter thrombolysis (SA-CT) in treating supratentorial spontaneous intracerebral haemorrhage (sICH) with small haematoma volumes (<30 mL).</p><p><strong>Methods: </strong>We analysed the clinical and long-term outcome data for patients who had haematoma volumes <30 mL and underwent SA-CT between August 2019 and June 2023. Then, we matched the patients receiving conservative treatment during the same period from a multicentre intracerebral haemorrhage database using propensity score matching. The outcomes included the restoration of independent standing ability and mortality within 1 year after onset.</p><p><strong>Results: </strong>340 patients were included in the final analysis. A greater proportion of patients in the surgery group regained the ability to stand independently within 1 year (89.1% vs 78.1%, p=0.049). The Kaplan-Meier curve showed that the cumulative standing rate in the surgery group was higher than that in the conservative group (90.4% vs 82.0%, p=0.007) within 1 year, and the median time to regain standing was shorter in the surgery group (30 days vs 34 days). The mortality rates were lower in the surgery group (p<0.05). Multivariate Cox regression analysis revealed that frameless robot-guided SA-CT (adjusted HR 1.80; 95% CI 1.37 to 2.38; p<0.001), age, haematoma volume, the severe Glasgow Coma Scale scores and pneumonia were independent factors associated with standing recovery within 1 year after onset.</p><p><strong>Conclusions: </strong>Frameless robot-guided SA-CT for small supratentorial haematoma with contralateral hemiplegia seems safe and potentially facilitates the recovery of independent standing ability and reduces the mortality rates.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-07-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144033077","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Yitong Jia, Fa Lin, Runting Li, Yi Yang, Xiaolin Chen, Shuo Wang
{"title":"Multiomics genetic insights into potential molecular targets for intracranial aneurysm.","authors":"Yitong Jia, Fa Lin, Runting Li, Yi Yang, Xiaolin Chen, Shuo Wang","doi":"10.1136/svn-2025-004175","DOIUrl":"https://doi.org/10.1136/svn-2025-004175","url":null,"abstract":"<p><strong>Background: </strong>This study aimed to identify multiomics therapeutic targets for aneurysmal subarachnoid haemorrhage (aSAH) and unruptured intracranial aneurysm (uIA) using Mendelian randomisation (MR), summary-data-based MR (SMR) and postanalysis methods.</p><p><strong>Methods: </strong>Significant genetic variables were extracted from multiple databases, including Expression Quantitative Trait Loci (eQTL) from eQTLGen and Genotype-Tissue Expression V.8, protein QTL from eight plasma studies and methylation QTL from the 2018 genome-wide methylation study<i>.</i> Key molecules linked to aSAH and uIA were identified through MR (SMR) and colocalisation analysis. Functional research and drug development relied on postanalysis approaches, including single-cell analysis, enrichment studies and molecular docking.</p><p><strong>Results: </strong>Nine genes and one protein associated with aSAH, along with two genes and one protein for uIA, were identified. DNA methylation variations significantly influenced outcomes. Colocalisation analysis showed most key molecules shared genetic variants with the diseases. The prioritised targets were PSMA4, PRCP, TNFSF12 and RELT. Enrichment and protein-protein interaction studies indicated these proteins acted mainly through the Phosphoinositide 3-kinase-Ak strain transformation (PI3K-Akt) pathway and cytokine interactions. Molecular docking confirmed stable binding of PRCP with benazepril. Single-cell analysis revealed high expression of prioritised targets in inflammatory cells. Phenome-Wide Association Study suggested potential pleiotropy of priority targets.</p><p><strong>Conclusions: </strong>The study identified key targets for aSAH and uIA, providing insights for developing preventive therapies and advancing research on intracranial aneurysm mechanisms.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-07-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144610055","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Vascular β-amyloid potentially colocalises with phosphorylated tau in cerebral amyloid angiopathy.","authors":"Hsin-Hsi Tsai, Bo-Ching Lee, Chia-Ju Liu, Pu-Tien Chiang, Ya-Chin Tsai, Li-Kai Tsai, Syu-Jyun Peng","doi":"10.1136/svn-2024-003774","DOIUrl":"10.1136/svn-2024-003774","url":null,"abstract":"<p><strong>Background: </strong>Tau pathology is observed in cerebral amyloid angiopathy (CAA) and is related to cognitive impairment and neurodegeneration. However, the relationship between tau pathology and amyloid accumulation in the vasculature is unknown. We aimed to assess if regional associations exist between vascular amyloid and tau protein in sporadic CAA.</p><p><strong>Method: </strong>We assessed cerebral amyloid and hyperphosphorylated tau in patients with probable CAA or Alzheimer's disease (AD) using <sup>11</sup>C-Pittsburgh compound B (PiB) and <sup>18</sup>F-T807 positron emission tomography (PET). PET data for each region of interest were extracted using an automated anatomical labelling atlas. We generated correlation matrices to investigate the regional correlations between PiB and T807 uptake, which were further adjusted for multiple comparisons. We evaluated if the severity of regional cortical superficial siderosis (cSS) mediates these associations.</p><p><strong>Results: </strong>67 patients with CAA (38 with intracerebral haemorrhage and 29 with cognitive impairment) and 21 patients with AD were included. Significant correlations between amyloid and tau PET uptake were observed in regions of interest for the temporal, parietal and occipital lobes in CAA (adjusted p<0.05); these correlations were not observed in AD. In CAA, the severity of regional cSS correlated positively with T807 uptake in the temporal (β=0.108, 95% CI 0.030 to 0.186, p=0.007) and occipital lobes (β=0.088, 95% CI 0.008 to 0.168, p=0.032). Regional cSS showed no mediating effect on the association between PiB and T807 in the occipital and temporal lobes.</p><p><strong>Conclusions: </strong>In CAA, tau pathology exhibits significant regional in situ correlations with amyloid deposition in the posterior brain, which suggests a distinct pathophysiology to AD.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144217311","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Predictors of futile recanalisation in patients with large infarct: a post-hoc analysis of the ANGEL-ASPECT trial.","authors":"Tingyu Yi, Xiaochuan Huo, Xiaohui Lin, Mengxing Wang, Yan-Min Wu, Zhinan Pan, Xiufen Zheng, Ding-Lai Lin, Yuesong Pan, Zhongrong Miao, Wenhuo Chen","doi":"10.1136/svn-2024-003382","DOIUrl":"https://doi.org/10.1136/svn-2024-003382","url":null,"abstract":"<p><strong>Background: </strong>Studies on futile recanalisation after endovascular therapy (EVT) for anterior circulation large vessel occlusion with large infarct were scarce. The present study aimed to explore the incidence and independent predictors of futile recanalisation in patients with large infarct.</p><p><strong>Methods: </strong>This is a post-hoc analysis of the ANGEL-Alberta Stroke Program Early CT (ASPECT) trial. A favourable outcome was defined as a 90-day modified Rankin Scale score of 0-3; successful reperfusion was defined as extended thrombolysis in cerebral infarction 2b, 2c and 3 on final angiogram; and futile recanalisation was defined as unfavourable outcome despite successful reperfusion. We performed multivariate analysis to identify the predictors of futile recanalisation after EVT in patients with large infarct.</p><p><strong>Results: </strong>A total of 183 patients were included: 91 (49.7%) patients had futile recanalisation and 92 (51.3%) had meaningful recanalisation. In multivariable logistic regression analysis, nonmodifiable factors included older age (age ≥68 years, OR=3.4, 95%CI 1.5 to 7.7, p= 0.003), female sex (OR=2.78, 95%CI 1.28 to 7.27, p=0.01), higher National Institutes of Health Stroke Scale score (NIHSS ≥16, OR=3.1, 95%CI 1.2 to 8.3, p=0.035), diabetes (OR=3.1, 95%CI 1.2 to 8.3, p=0.017) and symptomatic intracranial haemorrhage (sICH) (OR=9.1, 95%CI 1.0 to 80.7, p=0.049), and modifiable factors included larger final infarct volume (FIV ≥174.7, OR=6.2, 95%CI 2.5 to 15.7, p<0.001) and postoperative respiratory failure (OR=14.1, 95%CI 1.6 to 124.8, p=0.018), which were independent predictors of futile recanalisation.</p><p><strong>Conclusions: </strong>Futile recanalisation occurred in approximately half of patients who had an acute stroke with large infarct after EVT in the ANGEL-ASPECT trial. Nonmodifiable factors that included old age, high baseline NIHSS score, diabetes mellitus, sICH and large FIV, and modifiable factors that included respiratory failure were independent predictors of futile recanalisation after EVT for large ischaemic strokes. Stroke-related pneumonia control may improve prognosis.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144585316","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Mu-Rui Zheng, Pan Chen, Yuan Feng, Qinge Zhang, Zhaohui Su, Teris Cheung, Gabor S Ungvari, Chee H Ng, Yu-Tao Xiang
{"title":"Prevalence of depression and cognitive impairment and their inter-relationship and association with quality of life among older stroke survivors: the findings of a national survey in China.","authors":"Mu-Rui Zheng, Pan Chen, Yuan Feng, Qinge Zhang, Zhaohui Su, Teris Cheung, Gabor S Ungvari, Chee H Ng, Yu-Tao Xiang","doi":"10.1136/svn-2024-003623","DOIUrl":"https://doi.org/10.1136/svn-2024-003623","url":null,"abstract":"<p><strong>Background: </strong>Post-stroke depression (PSD) and post-stroke cognitive impairment (PSCI) are prevalent neuropsychiatric problems that are associated with high disability burden and low quality of life (QoL). This study explored the PSD-PSCI network, along with the interaction and association with QoL among Chinese older stroke survivors.</p><p><strong>Methods: </strong>Data from the 2017-2018 wave of the Chinese Longitudinal Healthy Longevity Survey were obtained to investigate the inter-relationship between PSD and PSCI among older stroke survivors. Central and bridge symptoms within the PSD-PSCI network and their association with QoL were explored. Depressive symptoms, cognitive impairment and QoL were measured using the 10-item Center for Epidemiologic Studies Depression Scale (CESD-10), Mini-Mental State Examination and the WHO QoL-brief version, respectively.</p><p><strong>Results: </strong>The prevalence of PSD and PSCI among older stroke survivors was 31.5% and 22.1%, respectively. In the PSD-PSCI network, 'feeling blue/depressed' (CESD3, strength: 1.117) and 'Attention and calculation' (At_C, strength: 0.972) were the most influential symptoms, while 'Naming' (Nam, bridge strength: 0.175) was the most significant bridge symptom. Notably, 'Sleep disturbances' (CESD10) had the strongest association with lower QoL.</p><p><strong>Conclusion: </strong>This study revealed that both PSD and PSCI were prevalent among older stroke survivors. The key central and bridge symptoms in the PSD-PSCI network, along with those symptoms that negatively impact on QoL, should be prioritised in targeted interventions to enhance treatment outcomes in this population.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2025-07-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144585317","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Angela C C Jochems, Susana Muñoz Maniega, Una Clancy, Carmen Arteaga Reyes, Daniela Jaime Garcia, Maria Del C Valdés Hernández, Francesca M Chappell, Gayle Barclay, Charlotte Jardine, Donna McIntyre, Iona Gerrish, Stewart Wiseman, Michael S Stringer, Michael J Thrippleton, Fergus Doubal, Joanna M Wardlaw
{"title":"Definitions of white matter hyperintensity change: impact on estimates of progression and regression.","authors":"Angela C C Jochems, Susana Muñoz Maniega, Una Clancy, Carmen Arteaga Reyes, Daniela Jaime Garcia, Maria Del C Valdés Hernández, Francesca M Chappell, Gayle Barclay, Charlotte Jardine, Donna McIntyre, Iona Gerrish, Stewart Wiseman, Michael S Stringer, Michael J Thrippleton, Fergus Doubal, Joanna M Wardlaw","doi":"10.1136/svn-2024-003300","DOIUrl":"10.1136/svn-2024-003300","url":null,"abstract":"<p><strong>Background: </strong>White matter hyperintensity (WMH) progression is well documented; WMH regression is more contentious, which might reflect differences in defining WMH change. We compared four existing WMH change definitions in one population to determine the effect of definition on WMH regression.</p><p><strong>Methods: </strong>We recruited patients with minor non-disabling ischaemic stroke who underwent MRI 1-3 months after stroke and 1 year later. We assessed WMH volume (in absolute mL and % intracranial volume) and applied four different definitions, including two thresholds (based on SD or mL), percentile and quintile approaches.</p><p><strong>Results: </strong>In 198 participants, mean age 65.5 (SD=11.13), baseline WMH volume was 15.46 mL (SD=19.2), the mean net WMH volume change was 0.98 mL (SD=2.84), range -7.98 to +12.84 mL. Proportion regressing/stable/progressing WMH were threshold 1 (SD), 29.8%/55.6%/14.6%; threshold 2(mL), 29.8%/16.7%/53.5%; percentile approach, 28.3%/21.2%/50.5%. The quintile approach includes five groups with quintile 3 reflecting no change (N=40), quintiles 1 and 2 any WMH decrease (N=80) and quintiles 4 and 5 any WMH increase (N=78).</p><p><strong>Conclusions: </strong>Different WMH change definitions cause big differences in how participants are categorised; additionally, non-normal WMH distribution precludes use of some definitions. Consistent use of an appropriate definition would facilitate data comparisons, particularly in clinical trials of potential WMH treatments.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":"411-414"},"PeriodicalIF":2.6,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12230215/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142367094","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Enayatullah Baki, Lea Baumgart, Victoria Kehl, Felix Hess, Andreas Wolfgang Wolff, Arthur Wagner, Moritz Roman Hernandez Petzsche, Tobias Boeckh-Behrens, Bernhard Hemmer, Bernhard Meyer, Jens Gempt, Silke Wunderlich
{"title":"Predictors of malignant swelling in space-occupying cerebellar infarction.","authors":"Enayatullah Baki, Lea Baumgart, Victoria Kehl, Felix Hess, Andreas Wolfgang Wolff, Arthur Wagner, Moritz Roman Hernandez Petzsche, Tobias Boeckh-Behrens, Bernhard Hemmer, Bernhard Meyer, Jens Gempt, Silke Wunderlich","doi":"10.1136/svn-2024-003360","DOIUrl":"10.1136/svn-2024-003360","url":null,"abstract":"<p><strong>Background: </strong>Malignant swelling is a fatal complication that can occur abruptly in space-occupying cerebellar infarction. We aimed to establish markers that predict malignant swelling in cerebellar infarction.</p><p><strong>Methods: </strong>We retrospectively analysed data of stroke patients who were treated in our hospital between 2014 and 2020. Malignant swelling was defined as a mass effect in the posterior cranial fossa, accompanied by a decrease in consciousness due to compression of the brainstem and/or the development of obstructive hydrocephalus. Statistical analyses were performed on multiple variables to identify predictors of malignant swelling.</p><p><strong>Results: </strong>Among 7284 stroke patients, we identified 487 patients with an infarct in the cerebellum. 93 patients were suitable for analysis having space-occupying cerebellar infarction. 33 of 93 (35.5%) patients developed malignant swelling. Multivariable analysis revealed infarct volume as the main predictor being independently associated with the development of malignant swelling with a cut-off infarct volume of 38 cm<sup>3</sup> being associated with a swelling rate of >50% (OR 32.0, p<0.001). Higher NIHSS (National Institutes of Health Stroke Scale) score on admission (median NIHSS 12 vs 4, OR 1.078; p=0.008) and the presence of additional brainstem infarction (51.5% vs 16.7%, OR 5.312; p=0.013) were associated with the development of malignant swelling in univariate analyses. 13 of 33 (39.4%) cases of malignant swellings occurred after more than 3 days.</p><p><strong>Conclusions: </strong>Infarct volume was the key significant predictor of malignant swelling in space-occupying cerebellar infarction. With many cases of malignant swelling occurring after more than 72 hours, we advocate prolonged neurological monitoring.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":"323-329"},"PeriodicalIF":2.6,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12230214/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142113761","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Angioplasty and/or stenting following successful mechanical thrombectomy for intracranial atherosclerosis-related emergent large vessel occlusive stroke (ASSET): protocol of a multicentre randomised trial.","authors":"Geng Liao, Hongyu Qiao, Chengbo Dai, Weiwen Yi, Liang Zhang, Zai Liang, Li Li, Yuemei He, Zhenyu Zhang, Zhong Ji, Li'an Huang","doi":"10.1136/svn-2024-003435","DOIUrl":"10.1136/svn-2024-003435","url":null,"abstract":"<p><strong>Rationale: </strong>The management of residual stenosis after mechanical thrombectomy in patients with intracranial atherosclerotic stenosis-related emerge large vessel occlusive (ICAS-LVO) stroke is still unclear question in clinical practice.</p><p><strong>Aim: </strong>To demonstrate the design of a clinical trial on emergency balloon angioplasty and/or stenting (BAS) combined with standard medical treatment (SMT) for residual stenosis of ICAS-LVO stroke patients with successful recanalisation.</p><p><strong>Design: </strong>ASSET is a multicentre, prospective, randomised, open-label, blinded end-point, controlled clinical trial designed (PROBE) by investigators. This trial evaluates the effectiveness and the safety of emergency BAS in combination with SMT compared with SMT alone in ICAS-LVO stroke patients with successful recanalisation (defined as expanded treatment in cerebral ischaemia grade of 2b50-3 and maintained for more than 20 min) and residual stenosis (defined as ≥50%) up to 24 hours after the onset of symptoms or the last known well.</p><p><strong>Outcome: </strong>The primary outcome assessed at 90 (±7) days after randomisation is the incidence of ischaemic stroke in the responsible vessel. Symptomatic intracranial haemorrhage within 24 (±3) hours is the primary safety outcome.</p><p><strong>Discussion: </strong>The ASSET trial is designed to provide strong evidence on the effectiveness and safety of emergency BAS to treat residual stenosis after successful recanalisation in patients with ICAS-LVO stroke.</p><p><strong>Trial registration number: </strong>ChiCTR2300079069.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":"379-385"},"PeriodicalIF":2.6,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12230212/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142356519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}