Journal of Investigative Medicine最新文献

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Rationale and design of ProUrokinase in Mild IsChemic strokE (PUMICE): a multicentre, prospective, randomised, open-label, blinded-endpoint controlled trial. 轻度缺血性脑卒中患者使用 ProUrokinase(PUMICE)的原理和设计:一项多中心、前瞻性、随机、开放标签、盲端点对照试验。
IF 2.6 1区 医学
Journal of Investigative Medicine Pub Date : 2024-12-30 DOI: 10.1136/svn-2023-002673
Yunyun Xiong, Manjun Hao, Yuesong Pan, Chunmiao Duan, Xueyan Feng, Hao Li, Na Wu, Liyuan Wang, Xia Meng, Xingquan Zhao, Yongjun Wang
{"title":"Rationale and design of ProUrokinase in Mild IsChemic strokE (PUMICE): a multicentre, prospective, randomised, open-label, blinded-endpoint controlled trial.","authors":"Yunyun Xiong, Manjun Hao, Yuesong Pan, Chunmiao Duan, Xueyan Feng, Hao Li, Na Wu, Liyuan Wang, Xia Meng, Xingquan Zhao, Yongjun Wang","doi":"10.1136/svn-2023-002673","DOIUrl":"10.1136/svn-2023-002673","url":null,"abstract":"<p><strong>Background and purpose: </strong>Recombinant human prourokinase (rhPro-UK) is a new generation of specific plasminogen activator, that is non-inferior to alteplase in acute ischemic stroke. We aimed to investigate the efficacy and safety of rhPro-UK compared with standard medical treatment in acute mild ischemic stroke within 4.5 hours of symptom onset.</p><p><strong>Methods and design: </strong>Prourokinase in mild ischemic stroke is a multicentre, prospective, randomised, open-label, blinded-endpoint controlled trial. Patients who had an acute ischemic stroke within 4.5 hours from symptom onset and with baseline National Institutes of Health Stroke Scale (NIHSS) score ≤ 5 will be recruited. Patients will be randomly assigned (1:1) to receive intravenous rhPro-UK (35 mg) or standard medical treatment. The follow-up duration will be 90 days. The calculated sample size is 1446.</p><p><strong>Study outcomes: </strong>Primary efficacy outcome is an excellent functional outcome, defined as a modified Rankin Scale (mRS) score ≤ 1 at 90 days. Secondary efficacy outcomes include ordinal distribution of mRS at 90 days, mRS score ≤ 2 at 90 days, early neurological improvement at 24 hours (a decrease of NIHSS score ≥ 4 points compared with baseline or NIHSS score ≤ 1 point), Barthel index of 75-100 points at 90 days, quality of life at 90 days, and activities of daily living at 90 days. Safety outcomes are symptomatic intracranial haemorrhage within 36 hours, mortality at 90 days, moderate and severe systematic bleeding at 90 days, and adverse events/serious adverse events within 90 days.</p><p><strong>Discussion: </strong>This large phase III randomised clinical trial will answer the question of whether thrombolysis is beneficial for acute mild ischemic stroke, and may provide evidence for rhPro-UK in patients had an acute mild ischemic stroke within 4.5 hours of symptom onset.</p><p><strong>Trial registration number: </strong>NCT05507645.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":"715-722"},"PeriodicalIF":2.6,"publicationDate":"2024-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11791633/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139724605","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}
引用次数: 0
Recurrent intracerebral haemorrhages as main manifestations in cerebral amyloid angiopathy-related inflammation. 复发性脑出血是脑淀粉样血管病相关炎症的主要表现。
IF 2.6 1区 医学
Journal of Investigative Medicine Pub Date : 2024-12-30 DOI: 10.1136/svn-2024-003100
Ya Su, Yi Dong, Xin Cheng
{"title":"Recurrent intracerebral haemorrhages as main manifestations in cerebral amyloid angiopathy-related inflammation.","authors":"Ya Su, Yi Dong, Xin Cheng","doi":"10.1136/svn-2024-003100","DOIUrl":"10.1136/svn-2024-003100","url":null,"abstract":"<p><p>Cerebral amyloid angiopathy-related inflammation (CAA-ri) is a relatively rare and treatable subtype of CAA. We have herein reported a case of CAA-ri with repeated recurrent lobar haemorrhages within a short time as the main manifestations and effectively treated with immunosuppressive therapy. Our case expanded the clinical spectrum of CAA-ri and indicated that leptomeningeal inflammation might be a trigger and bleeding source for recurrent haemorrhage in CAA.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":"738-740"},"PeriodicalIF":2.6,"publicationDate":"2024-12-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11791626/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"140327292","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}
引用次数: 0
Development of a deep learning method to identify acute ischaemic stroke lesions on brain CT. 开发一种深度学习方法来识别脑 CT 上的急性缺血性中风病灶。
IF 2.6 1区 医学
Journal of Investigative Medicine Pub Date : 2024-12-25 DOI: 10.1136/svn-2024-003372
Alessandro Fontanella, Wenwen Li, Grant Mair, Antreas Antoniou, Eleanor Platt, Paul Armitage, Emanuele Trucco, Joanna M Wardlaw, Amos Storkey
{"title":"Development of a deep learning method to identify acute ischaemic stroke lesions on brain CT.","authors":"Alessandro Fontanella, Wenwen Li, Grant Mair, Antreas Antoniou, Eleanor Platt, Paul Armitage, Emanuele Trucco, Joanna M Wardlaw, Amos Storkey","doi":"10.1136/svn-2024-003372","DOIUrl":"10.1136/svn-2024-003372","url":null,"abstract":"<p><strong>Background: </strong>CT is commonly used to image patients with ischaemic stroke but radiologist interpretation may be delayed. Machine learning techniques can provide rapid automated CT assessment but are usually developed from annotated images which necessarily limits the size and representation of development data sets. We aimed to develop a deep learning (DL) method using CT brain scans that were labelled but not annotated for the presence of ischaemic lesions.</p><p><strong>Methods: </strong>We designed a convolutional neural network-based DL algorithm to detect ischaemic lesions on CT. Our algorithm was trained using routinely acquired CT brain scans collected for a large multicentre international trial. These scans had previously been labelled by experts for acute and chronic appearances. We explored the impact of ischaemic lesion features, background brain appearances and timing of CT (baseline or 24-48 hour follow-up) on DL performance.</p><p><strong>Results: </strong>From 5772 CT scans of 2347 patients (median age 82), 54% had visible ischaemic lesions according to experts. Our DL method achieved 72% accuracy in detecting ischaemic lesions. Detection was better for larger (80% accuracy) or multiple (87% accuracy for two, 100% for three or more) lesions and with follow-up scans (76% accuracy vs 67% at baseline). Chronic brain conditions reduced accuracy, particularly non-stroke lesions and old stroke lesions (32% and 31% error rates, respectively).</p><p><strong>Conclusion: </strong>DL methods can be designed for ischaemic lesion detection on CT using the vast quantities of routinely collected brain scans without the need for lesion annotation. Ultimately, this should lead to more robust and widely applicable methods.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-12-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689301","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}
引用次数: 0
Dual antiplatelet versus alteplase in anterior and posterior circulation minor stroke. 双重抗血小板与阿替普酶在轻度卒中前后循环中的作用。
IF 2.6 1区 医学
Journal of Investigative Medicine Pub Date : 2024-12-11 DOI: 10.1136/svn-2024-003705
Yu Cui, Hui-Sheng Chen
{"title":"Dual antiplatelet versus alteplase in anterior and posterior circulation minor stroke.","authors":"Yu Cui, Hui-Sheng Chen","doi":"10.1136/svn-2024-003705","DOIUrl":"10.1136/svn-2024-003705","url":null,"abstract":"<p><strong>Objective: </strong>The Antiplatelet versus R-tPA for Acute Mild Ischaemic Stroke trial has demonstrated the non-inferiority of dual antiplatelet therapy (DAPT) to alteplase in minor non-disabling stroke. This prespecified secondary analysis aimed to investigate whether the treatment effects were similar across stroke territories.</p><p><strong>Methods: </strong>Participants were divided according to stroke territory, which were subdivided into DAPT and alteplase. An excellent functional outcome at 90 days defined as modified Rankin Scale scoring 0-1 was primary outcome. National Institutes of Health Stroke Scale (NIHSS) score change and early neurological improvement measured by a 2-point decline in NIHSS score at 24 hours were secondary outcomes. Symptomatic intracerebral haemorrhage (sICH) and bleeding events were safety outcomes. Primary analyses adjusted unbalanced baseline characteristics between treatments by multivariate logistic regression.</p><p><strong>Results: </strong>A total of 719 patients were included: 566 in anterior circulation stroke (ACS) and 153 in posterior circulation stroke (PCS). Primary outcome was 94.1% in DAPT and 91.7% in alteplase among ACS patients (adjusted risk difference (RD) and 95% CI, 1.5% (-1.5% to 4.6%), p=0.32), while 91.2% in DAPT and 91.8% in alteplase among PCS patients (adjusted RD and 95% CI, -2.1% (-8.5% to 4.4%), p=0.53). Compared with alteplase, DAPT was associated with lower risk of sICH (p=0.03) and bleeding events (p<0.001) in ACS, but only lower risk of bleeding events (p=0.007) in PCS. Additionally, among ACS patients, the alteplase was superior to DAPT in terms of decrease in NIHSS score at 24 hours compared with admission (adjusted geometric mean ratio and 95% CI, -0.09 (-0.16 to -0.03), p=0.005) and early neurological improvement (adjusted RD and 95% CI, -7.2% (-11.6% to -2.7%), p=0.001).</p><p><strong>Conclusion: </strong>Among ischaemic stroke with minor non-disabling symptoms, DAPT was similar with intravenous alteplase regarding long-term functional outcome and better safety regardless of ACS or PCS. The potential benefit of intravenous alteplase regarding early neurological improvement in patients with ACS warrants further investigation.</p><p><strong>Trial registration number: </strong>NCT03661411.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-12-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142814606","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}
引用次数: 0
Baseline systolic blood pressure and efficacy of dual antiplatelet in acute ischaemic stroke. 急性缺血性脑卒中患者基线收缩压及双抗血小板的疗效。
IF 2.6 1区 医学
Journal of Investigative Medicine Pub Date : 2024-12-08 DOI: 10.1136/svn-2024-003615
Yu Cui, Yue Wang, Hui-Sheng Chen
{"title":"Baseline systolic blood pressure and efficacy of dual antiplatelet in acute ischaemic stroke.","authors":"Yu Cui, Yue Wang, Hui-Sheng Chen","doi":"10.1136/svn-2024-003615","DOIUrl":"10.1136/svn-2024-003615","url":null,"abstract":"<p><strong>Objective: </strong>Systolic blood pressure (SBP) affects the risk of early neurological deterioration (END). This subgroup analysis of Antiplatelet Therapy in Acute Mild to Moderate Ischemic Stroke (ATAMIS) trial aimed to explore whether SBP at admission affected the efficacy of different antiplatelet therapies in preventing END.</p><p><strong>Methods: </strong>Based on the modified intention-to-treat analysis set of the ATAMIS trial, patients were divided into two subgroups according to whether SBP at admission was equal to or higher than 140 mm Hg, which were further subdivided into clopidogrel plus aspirin and aspirin alone treatments according to the randomised assignment. We conducted multivariable regression analyses to detect relationship between SBP at admission and END, as well as efficacy of different antiplatelet therapies in each SBP subgroup. Primary endpoint was END defined as ≥2-point increase in 7-day National Institutes of Health Stroke Scale score. Safety endpoints included intracranial haemorrhage and bleeding events during the trial.</p><p><strong>Results: </strong>This study included 2915 patients. Risk of END raised by 16% as SBP at admission increased by every 10 mm Hg (p<0.001). Clopidogrel plus aspirin resulted in significantly lower risk of END than aspirin alone in patients with SBP≥140 mm Hg (5.5% vs 7.9%; adjusted risk difference (RD) and 95% CI -2.5% (-4.1% to -1.0%)), but not in those with SBP<140 mm Hg (3.4% vs 4.2%; adjusted RD and 95% CI -0.8% (-3.2% to 1.7%)). Efficacy of different antiplatelet therapies and SBP did not show significant interaction (p=0.50). Safety endpoints were similar between treatments in SBP subgroups.</p><p><strong>Conclusion: </strong>The risk of END increases with elevated SBP at admission among patients with acute mild-to-moderate ischaemic stroke who are not suitable for reperfusion treatments. Fewer END occurred following clopidogrel plus aspirin compared with aspirin alone across different SBP levels. The finding should be interpreted cautiously.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142796574","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}
引用次数: 0
Association of APOE genotype with CT markers of cerebral amyloid angiopathy in spontaneous intracerebral haemorrhage. 自发性脑出血患者的 APOE 基因型与脑淀粉样血管病 CT 标记的关系
IF 2.6 1区 医学
Journal of Investigative Medicine Pub Date : 2024-12-08 DOI: 10.1136/svn-2024-003477
Qiong Yang, Xiangzhu Zeng, Lu Tang, Xiaolu Liu, Kailin Xia, Feng Gao, Xu Huang, Nan Li, Dongsheng Fan
{"title":"Association of <i>APOE</i> genotype with CT markers of cerebral amyloid angiopathy in spontaneous intracerebral haemorrhage.","authors":"Qiong Yang, Xiangzhu Zeng, Lu Tang, Xiaolu Liu, Kailin Xia, Feng Gao, Xu Huang, Nan Li, Dongsheng Fan","doi":"10.1136/svn-2024-003477","DOIUrl":"10.1136/svn-2024-003477","url":null,"abstract":"<p><strong>Background and objective: </strong>We investigated the association of <i>APOE</i> alleles with CT-based cerebral amyloid angiopathy (CAA) markers including subarachnoid extension (SAE) and finger-like projection (FLP).</p><p><strong>Methods: </strong>We included patients with acute primary supratentorial intracerebral haemorrhage (ICH) from a multicentre cohort in China. First, the association of <i>APOE</i> with ICH location (lobar vs non-lobar) was evaluated. Next, the relationships of <i>APOE</i> with SAE, FLP, and the coexistence of the two (SAE+FLP) were evaluated.</p><p><strong>Results: </strong>533 patients with supratentorial ICH were enrolled. Among them were 138 patients with lobar ICH and 395 with non-lobar ICH. Compared with the non-lobar group, <i>APOE</i> ε4 (OR 1.894, 95% CI 1.138 to 3.154, p=0.014) and ε2/ε4 (OR 6.098, 95% CI 1.414 to 26.293, p=0.015) were associated with lobar ICH. With regard to CAA markers, <i>APOE</i> ε2 was associated with SAE (OR 2.109, 95% CI 1.167 to 3.810, p=0.013), ε4 was associated with FLP and SAE+FLP (OR 3.026, 95% CI 1.353 to 6.767, p=0.007; OR 3.514, 95% CI 1.485 to 8.316, p=0.004, respectively) and ε2/ε4 was associated with all three factors (SAH: OR 7.599, 95% CI 1.764 to 32.734, p=0.006; FLP: OR 20.333, 95% CI 3.278 to 126.137, p=0.001; SAE+FLP: OR 30.568, 95% CI 4.460 to 209.503, p<0.001) after adjusting for age, and remained significant after adjusting for age and ICH volume.</p><p><strong>Conclusion: </strong>In patients with spontaneous supratentorial ICH, <i>APOE</i> ε2 and ε4 alleles were associated with SAE and FLP, respectively, suggesting <i>APOE</i> allele-specific effects on CT markers of CAA and their potential mechanisms.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-12-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142796573","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}
引用次数: 0
IRIS, a randomised, double-blind, placebo-controlled trial of interleukin-6 receptor inhibition undergoing endovascular treatment in acute anterior circulation ischaemic stroke: study rationale and design. IRIS是一项随机、双盲、安慰剂对照试验,研究急性前循环缺血性卒中患者血管内治疗白介素-6受体抑制:研究原理和设计。
IF 2.6 1区 医学
Journal of Investigative Medicine Pub Date : 2024-11-28 DOI: 10.1136/svn-2024-003574
Xuehong Chu, Zhengfei Ma, Yifeng Liu, Jun Sun, Ning Wang, Chaoqun Li, Xiangyang Feng, Jianqiao Li, Benxiao Wang, Chen Zhou, Chuanhui Li, Wenbo Zhao, Xunming Ji, Chuanjie Wu
{"title":"IRIS, a randomised, double-blind, placebo-controlled trial of interleukin-6 receptor inhibition undergoing endovascular treatment in acute anterior circulation ischaemic stroke: study rationale and design.","authors":"Xuehong Chu, Zhengfei Ma, Yifeng Liu, Jun Sun, Ning Wang, Chaoqun Li, Xiangyang Feng, Jianqiao Li, Benxiao Wang, Chen Zhou, Chuanhui Li, Wenbo Zhao, Xunming Ji, Chuanjie Wu","doi":"10.1136/svn-2024-003574","DOIUrl":"https://doi.org/10.1136/svn-2024-003574","url":null,"abstract":"<p><strong>Rationale: </strong>Neuroprotective strategies based on reperfusion therapy hold substantial promise for acute ischaemic stroke (AIS). Preclinical research indicates that tocilizumab, an interleukin-6 receptor antagonist, can attenuate ischaemia-reperfusion damage by exerting anti-inflammatory and neuroprotective effects.</p><p><strong>Aim: </strong>To determine tocilizumab's efficacy and safety when combined with endovascular thrombectomy (EVT) in patients with acute anterior circulation large vessel occlusion (LVO).</p><p><strong>Sample size estimates: </strong>To determine a 30% decrease in average infarct core volume comparing the intervention and historical control groups (mean increase of 18.7 mL (SD=9.7 mL) post-thrombectomy) via a two-sided test (alpha=0.05, power=80%), accounting for a 10% drop-out rate, we plan to recruit 108 participants.</p><p><strong>Methods and design: </strong>This trial is designed as a randomised, multicentre, double-blind, placebo-controlled trial. Patients will be randomly and evenly allocated to the tocilizumab or placebo groups.</p><p><strong>Study outcomes: </strong>The primary endpoint is the change in infarct core volume between baseline and 72 hours post-treatment. Secondary outcomes include the 90-day modified Rankin scale score (0-2, indicating functional independence). The key safety endpoints include 90-day mortality and symptomatic intracerebral haemorrhage within 72 hours after EVT.</p><p><strong>Discussion: </strong>Administering tocilizumab within 24 hours of stroke as an adjunct to EVT may effectively reduce the infarct core volume for patients experiencing AIS with anterior circulation LVO, potentially improving functional outcomes in these patients.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142751872","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}
引用次数: 0
Improved functional outcome for stroke patients with low ASPECTS score large core infarctions: 1-year follow-up of three randomised trials. 低ASPECTS评分大核心梗死的脑卒中患者功能预后改善:3项随机试验的1年随访。
IF 2.6 1区 医学
Journal of Investigative Medicine Pub Date : 2024-11-28 DOI: 10.1136/svn-2024-003868
Yang Zhang, David Wang, Yi Sui
{"title":"Improved functional outcome for stroke patients with low ASPECTS score large core infarctions: 1-year follow-up of three randomised trials.","authors":"Yang Zhang, David Wang, Yi Sui","doi":"10.1136/svn-2024-003868","DOIUrl":"https://doi.org/10.1136/svn-2024-003868","url":null,"abstract":"","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142755629","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}
引用次数: 0
Intra-arterial tenecteplase after successful endovascular therapy (ANGEL-TNK): protocol of a multicentre, open-label, blinded end-point, prospective, randomised trial. 血管内治疗成功后的动脉内替尼西普酶(ANGEL-TNK):一项多中心、开放标签、终点盲法、前瞻性、随机试验的方案。
IF 2.6 1区 医学
Journal of Investigative Medicine Pub Date : 2024-11-21 DOI: 10.1136/svn-2024-003318
Xiaochuan Huo, Gang Luo, Dapeng Sun, Thanh Nguyen, Mohamad Abdalkader, Wenhuo Chen, Xiaoxi Yao, Guangxiong Yuan, Tingyu Yi, Hongxin Han, Yuesong Pan, Tudor G Jovin, David S Liebeskind, Liping Liu, Xingquan Zhao, Zeguang Ren, Yilong Wang, Yongjun Wang, Bernard Yan, Zhongrong Miao
{"title":"Intra-arterial tenecteplase after successful endovascular therapy (ANGEL-TNK): protocol of a multicentre, open-label, blinded end-point, prospective, randomised trial.","authors":"Xiaochuan Huo, Gang Luo, Dapeng Sun, Thanh Nguyen, Mohamad Abdalkader, Wenhuo Chen, Xiaoxi Yao, Guangxiong Yuan, Tingyu Yi, Hongxin Han, Yuesong Pan, Tudor G Jovin, David S Liebeskind, Liping Liu, Xingquan Zhao, Zeguang Ren, Yilong Wang, Yongjun Wang, Bernard Yan, Zhongrong Miao","doi":"10.1136/svn-2024-003318","DOIUrl":"10.1136/svn-2024-003318","url":null,"abstract":"<p><strong>Background: </strong>Despite successful reperfusion after thrombectomy for large vessel occlusion (LVO) stroke, up to half of patients are dependent or dead at 3-month follow-up.The aim of the current study is to demonstrate safety and efficacy of administering adjunct intra-arterial (IA) tenecteplase in anterior circulation LVO patients who have achieved successful reperfusion defined as eTICI 2b50 to 3.</p><p><strong>Methods: </strong>ANGEL-TNK is a multicentre, open-label, assessor-blinded endpoint, prospective randomised, controlled trial that will enrol up to 256 patients. Patients who meet inclusion criteria with anterior circulation LVO stroke and successful reperfusion will be randomised to receive IA tenecteplase or best medical management at 1:1 ratio.</p><p><strong>Results: </strong>The primary endpoint is a 90-day excellent outcome defined as modified Rankin Scale (mRS) 0-1. The primary safety endpoint is symptomatic intracranial haemorrhage within 48 hours from randomisation. Secondary endpoints include 90-day ordinal mRS, mRS 0-2, mRS 0-3, all-cause mortality and any intracranial haemorrhage.</p><p><strong>Conclusion: </strong>In patients with anterior circulation LVO stroke, the ANGEL-TNK trial will inform whether adjunct IA tenecteplase administered after successful thrombectomy reperfusion improves patient outcomes.</p><p><strong>Trial registration number: </strong>NCT05624190.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-11-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142367097","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}
引用次数: 0
Clinical outcomes of endovascular interventions for cerebral venous thrombosis in Japan: a nationwide retrospective study. 日本脑静脉血栓的血管内介入治疗临床结果:一项全国性回顾研究。
IF 2.6 1区 医学
Journal of Investigative Medicine Pub Date : 2024-11-20 DOI: 10.1136/svn-2024-003639
Atsushi Senda, Hiroshi Suginaka, Koji Morishita, Kiyohide Fushimi
{"title":"Clinical outcomes of endovascular interventions for cerebral venous thrombosis in Japan: a nationwide retrospective study.","authors":"Atsushi Senda, Hiroshi Suginaka, Koji Morishita, Kiyohide Fushimi","doi":"10.1136/svn-2024-003639","DOIUrl":"https://doi.org/10.1136/svn-2024-003639","url":null,"abstract":"<p><strong>Introduction: </strong>Cerebral venous thrombosis (CVT) is a rare but serious disease. Despite anticoagulation being the cornerstone therapy, some patients experience worsening disease, necessitating alternative treatment. Endovascular treatment is an anticipated option with an uncertain clinical relevance. The aim of this study was to assess the clinical effects and efficacy of endovascular therapy and identify patient populations that may benefit from treatment.</p><p><strong>Patients and methods: </strong>This retrospective study examined patient data from April 2014 to March 2022 that were extracted from a nationwide Japanese Diagnosis Procedure Combination database. The primary outcome was in-hospital mortality. The secondary outcomes included modified Rankin Scale (mRS) scores and post-hospitalisation complications of cerebral infarction and intracranial haemorrhage. Severity was adjusted using a generalised linear mixed model, and propensity-score matching was employed to compare outcomes between treatment groups.</p><p><strong>Results: </strong>The study included 2901 patients; 240 patients in the endovascular treatment group were matched with 240 patients in the standard treatment group. After adjusting for background factors, endovascular treatment did not improve in-hospital mortality (adjusted OR 1.45; 95% CI 0.74 to 2.16) or the mRS score (adjusted OR 0.89, 95% CI 0.56 to 1.23). No subpopulations that could benefit from endovascular treatment were identified. Post-hospitalisation cerebral infarction and intracranial haemorrhage did not increase with endovascular treatment (0.8% in the endovascular treatment group vs 1.2% in the standard treatment group).</p><p><strong>Conclusion: </strong>Endovascular treatment showed no significant benefit for patients with CVT, indicating that treatment guidelines need to be refined. Our findings can guide clinical decisions and suggest the necessity of further research on potential benefits in specific subpopulations.</p>","PeriodicalId":48733,"journal":{"name":"Journal of Investigative Medicine","volume":" ","pages":""},"PeriodicalIF":2.6,"publicationDate":"2024-11-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142689299","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}
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