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Item type:Publication, Safety and efficacy of low-intensity versus standard monitoring following intravenous thrombolytic treatment in patients with acute ischaemic stroke (OPTIMISTmain): an international, pragmatic, stepped-wedge, cluster-randomised, controlled non-inferiority trial(Elsevier BV, 2025-05) ;Craig S Anderson ;Debbie Summers ;Menglu Ouyang ;Yi SuiBrenda Johnson2Scopus© Citations 15 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Influence of renal function on blood pressure control and outcome in thrombolyzed patients after acute ischemic stroke: post-hoc analysis of the ENCHANTED trial(Frontiers Media SA, 2024-12-09) ;Xinwen Ren ;Chen Chen ;Xia Wang ;Qiang LiYang Zhao<jats:sec><jats:title>Background</jats:title><jats:p>The effect of renal impairment in patients who receive intravenous thrombolysis for acute ischemic stroke (AIS) is unclear. We aimed to determine the associations of renal impairment and clinical outcomes and any modification of the effect of intensive versus guideline-recommended blood pressure (BP) control in the BP arm of the International Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED).</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>We conducted a <jats:italic>post-hoc</jats:italic> analysis of the ENCHANTED BP arm, which involved 2,196 thrombolyzed AIS patients. Logistic regression models were used to define the association between eGFR and clinical outcomes of death, death or major disability [modified Rankin scale (mRS) scores 3–6], and major disability (mRS 3–5) at 90 days.</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of the 2,151 patients with available baseline renal function data (mean age 66.9 years; 38% women), 993 (46.2%), 822 (38.2%), and 336 (15.6%) had normal (eGFR ≥ 90 mL/min/1.73 m<jats:sup>2</jats:sup>), mildly (60–89), and moderate-to-severely impaired (&lt;60) renal function, respectively. Compared with patients with normal eGFR, mortality was higher in those with moderate-to-severe renal impairment (adjusted odds ratio 1.77, 95% confidence interval 1.05–2.99; <jats:italic>p</jats:italic> = 0.031 for trend). However, the difference in death or major disability (mRS 3–6) was not significant between groups. There was no heterogeneity in the effect of intensive versus guideline-recommended BP-lowering treatment on death by grades of renal function (<jats:italic>p</jats:italic> for interaction = 0.545).</jats:p></jats:sec><jats:sec><jats:title>Discussion</jats:title><jats:p>The presence of moderate-to-severe renal impairment is associated with increased mortality in thrombolyzed patients with AIS. Renal function does not modify the effect of early intensive BP-lowering treatment on death in this patient group.</jats:p></jats:sec>2 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, The third Intensive Care Bundle with Blood Pressure Reduction in Acute Cerebral Haemorrhage Trial (INTERACT3): an international, stepped wedge cluster randomised controlled trial(2023) ;Lu Ma ;Xin Hu ;Lili Song ;Xiaoying ChenMenglu OuyangScopus© Citations 221 1 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Prognostic significance of early urinary catheterization after acute stroke: Secondary analyses of the international HeadPoST trial(2020) ;Menglu Ouyang ;Laurent Billot ;Lili Song ;Xia WangChristine Roffe<jats:sec><jats:title>Background</jats:title><jats:p> An indwelling urinary catheter (IUC) is often inserted to manage bladder dysfunction, but its impact on prognosis is uncertain. We aimed to determine the association of IUC use on clinical outcomes after acute stroke in the international, multi-center, cluster crossover, Head Positioning in Acute Stroke Trial (HeadPoST). </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Data were analyzed on HeadPoST participants (n = 11,093) randomly allocated to the lying-flat or sitting-up head position. Binomial, logistic regression, hierarchical mixed models were used to determine associations of early insertion of IUC within seven days post-randomization and outcomes of death or disability (defined as “poor outcome,” scores 3–6 on the modified Rankin scale) and any urinary tract infection at 90 days with adjustment of baseline and post-randomization management covariates. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> Overall, 1167 (12%) patients had an IUC, but the frequency and duration of use varied widely across patients in different regions. IUC use was more frequent in older patients, and those with vascular comorbidity, greater initial neurological impairment (on the National Institutes of Health Stroke Scale), and intracerebral hemorrhage as the underlying stroke type. IUC use was independently associated with poor outcome (adjusted odds ratio (aOR): 1.40, 95% confidence interval (CI): 1.13–1.74), but not with urinary tract infection after adjustment for antibiotic treatment and stroke severity at hospital separation (aOR: 1.13, 95% CI: 0.59–2.18). The number exposed to IUC for poor outcome was 13. </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> IUC use is associated with a poor outcome after acute stroke. Further studies are required to inform appropriate use of IUC. </jats:p></jats:sec>Scopus© Citations 4 3 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Low blood pressure and adverse outcomes in acute stroke: HeadPoST study explanations(2020) ;Menglu Ouyang; ;Laurent Billot ;Xia WangLili SongScopus© Citations 12 1 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Smoking influences outcome in patients who had thrombolysed ischaemic stroke: the ENCHANTED study(2021) ;Lingli Sun ;Lili Song ;Jie Yang ;Richard I LindleyThompson Robinson<jats:sec><jats:title>Background and purpose</jats:title><jats:p>As studies vary in defining the prognostic significance of smoking in acute ischaemic stroke (AIS), we aimed to determine the relation of smoking and key outcomes in patient participants who had thrombolysed AIS of the international quasi-factorial randomised Enhanced Control of Hypertension and Thrombolysis Stroke Study (ENCHANTED).</jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p>Post-hoc analyses of ENCHANTED, an international quasi-factorial randomised evaluation of intravenous alteplase-dose comparison and levels of blood pressure control in patients who had thrombolysed AIS. Multivariable logistic regression models with inverse probability of treatment weighting (IPTW) propensity scores were used to determine associations of self-reported smoking status and clinical outcomes, according to 90-day modified Rankin Scale (mRS) scores and symptomatic intracerebral haemorrhage (sICH).</jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p>Of 4540 patients who had an AIS, there were 1008 (22.2%) current smokers who were younger and predominantly male, with more comorbidities of hypertension, coronary artery disease, atrial fibrillation and diabetes mellitus, and greater baseline neurological impairment, compared with non-smokers. In univariate analysis, current smokers had a higher likelihood of a favourable shift in mRS scores (OR 0.88, 95% CI 0.77 to 0.99; p=0.038) but this association reversed in a fully adjusted model with IPTW (adjusted OR 1.15, 95% CI 1.04 to 1.28; p=0.009). A similar trend was also apparent for dichotomised poor outcome (mRS scores 2–6: OR 1.18, 95% CI 1.05 to 1.33; p=0.007), but not with the risk of sICH across standard criteria.</jats:p></jats:sec><jats:sec><jats:title>Conclusion</jats:title><jats:p>Smoking predicts poor functional recovery in patients who had thrombolysed AIS.</jats:p></jats:sec><jats:sec><jats:title>Trial registration number</jats:title><jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="clintrialgov" xlink:href="NCT01422616">NCT01422616</jats:ext-link>.</jats:p></jats:sec>Scopus© Citations 8 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, INTEnsive care bundle with blood pressure reduction in acute cerebral hemorrhage trial (INTERACT3): study protocol for a pragmatic stepped-wedge cluster-randomized controlled trial(2021) ;Lili Song ;Xin Hu ;Lu Ma ;Xiaoying ChenMenglu Ouyang<jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>Early intensive blood pressure (BP) lowering remains the most promising treatment for acute intracerebral hemorrhage (ICH), despite discordant results between clinical trials and potential variation in the treatment effects by approach to control BP. As the third in a series of clinical trials on this topic, the INTEnsive care bundle with blood pressure Reduction in Acute Cerebral hemorrhage Trial (INTERACT3) aims to determine the effectiveness of a goal-directed care bundle protocol of early physiological control (intensive BP lowering, glycemic control, and pyrexia treatment) and reversal of anticoagulation, in acute ICH.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>INTERACT3 is a pragmatic, international, multicenter, stepped-wedge (4 phases/3 steps), cluster-randomized controlled trial to determine the effectiveness of a multifaceted care package in adult (age ≥ 18 years) patients (target 8360) with acute ICH (< 6 h of onset) recruited from 110 hospitals (average of 19 consecutive patients per phase) in low- and middle-income countries. After a control phase, each hospital implements the intervention (intensive BP lowering, target systolic < 140 mmHg; glucose control, target 6.1–7.8 mmol/L and 7.8–10.0 mmol/L in those without and with diabetes mellitus, respectively; anti-pyrexia treatment to target body temperature ≤ 37.5 °C; and reversal of anticoagulation, target international normalized ratio < 1.5 within 1 h). Information will be obtained on demographic and baseline clinical characteristics, in-hospital management, and 7-day outcomes. Central trained blinded assessors will conduct telephone interviews to assess physical function and health-related quality of life at 6 months. The primary outcome is the modified Rankin scale (mRS) at 6 months analyzed using ordinal logistic regression. The sample size of 8360 subjects provides 90% power (<jats:italic>α</jats:italic> = 0.05) to detect a 5.6% absolute improvement (shift) in the primary outcome of the intervention versus control standard care, with various assumptions.</jats:p> </jats:sec><jats:sec> <jats:title>Discussion</jats:title> <jats:p>As the largest clinical trial in acute ICH, INTERACT3 is on schedule to provide an assessment of the effectiveness of a widely applicable goal-directed care bundle for a serious condition in which a clearly proven treatment has yet to be established.</jats:p> </jats:sec><jats:sec> <jats:title>Trial registration</jats:title> <jats:p><jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://clinicaltrials.gov">ClinicalTrials.gov</jats:ext-link> NCT03209258. Registered on 1 July 2017. Chinese Trial Registry ChiCTR-IOC-17011787. Registered on 28 June 2017</jats:p> </jats:sec>Scopus© Citations 15 1 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Effects of intensive blood pressure lowering on cerebral ischaemia in thrombolysed patients: insights from the ENCHANTED trial(2023) ;Chen Chen ;Menglu Ouyang ;Sheila Ong ;Luyun ZhangGuobin ZhangScopus© Citations 5 5 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Comparative effects of intensive-blood pressure versus standard-blood pressure-lowering treatment in patients with severe ischemic stroke in the ENCHANTED trial(2020) ;Jatinder S. Minhas ;Xia Wang ;Richard I. Lindley ;Candice DelcourtLili Song9Scopus© Citations 16 - Some of the metrics are blocked by yourconsent settings
Item type:Publication, Stroke care and collaborative academic research in Latin America(2022); ; ;Francisca Urrutia; <jats:p>Objective. A narrative overview of regional academic research collaborations to address the increasing burden and gaps in care for patients at risk of, and who suffer from, stroke in Latin America (LA). Materials and methods. A summary of experiences and knowledge of the local situation is presented. No systematic literature review was performed. Results. The rapidly increasing burden of stroke poses immense challenges in LA, where prevention and management strategies are highly uneven and inadequate. Clinical research is increasing through various academic consortia and networks formed to overcome structural, funding and skill barriers. However, strengthening the ability to generate, analyze and interpret randomized evidence is central to further develop effective therapies and healthcare systems in LA. Conclusions. Regional networks foster the conduct of multicenter studies –particularly randomized controlled trials–, even in resource-poor regions. They also contribute to the external validity of international studies and strengthen systems of care, clinical skills, critical thinking, and international knowledge exchange.</jats:p>10 1Scopus© Citations 5