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Author: search.filters.author.Jiguang WangSubject: search.filters.subject.clinical trial

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    Clinical Prediction Algorithm (BRAIN) to Determine Risk of Hematoma Growth in Acute Intracerebral Hemorrhage
    (2015)
    Xia Wang
    ;
    Hisatomi Arima
    ;
    Rustam Al-Shahi Salman
    ;
    Mark Woodward
    ;
    Emma Heeley
    <jats:sec> <jats:title>Background and Purpose—</jats:title> <jats:p>We developed and validated a simple algorithm to predict the risk of hematoma growth in acute spontaneous intracerebral hemorrhage (ICH) to better inform clinicians and researchers in their efforts to improve outcomes for patients.</jats:p> </jats:sec> <jats:sec> <jats:title>Methods—</jats:title> <jats:p>We analyzed data from the computed tomography substudies of the pilot and main phases of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trials (INTERACT1 and 2, respectively). The study group was divided into a derivation cohort (INTERACT2, n=964) and a validation cohort (INTERACT1, n=346). Multivariable logistic regression was used to identify factors associated with clinically significant (≥6 mL) increase in hematoma volume at 24 hours after symptom onset. A parsimonious risk score was developed on the basis of regression coefficients derived from the logistic model.</jats:p> </jats:sec> <jats:sec> <jats:title>Results—</jats:title> <jats:p> A 24-point BRAIN score was derived from INTERACT2 (C-statistic, 0.73) based on baseline ICH volume (mL per score, ≤10=0, 10–20=5, &gt;20=7), recurrent ICH (yes=4), anticoagulation with warfarin at symptom onset (yes=6), intraventricular extension (yes=2), and number of hours to baseline computed tomography from symptom onset (≤1=5, 1–2=4, 2–3=3, 3–4=2, 4–5=1, &gt;5=0) predicted the probability of ICH growth (ranging from 3.4% for 0 point to 85.8% for 24 points) with good discrimination (C-statistic, 0.73) and calibration (Hosmer–Lemeshow <jats:italic>P</jats:italic> =0.82) in INTERACT1. </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>The simple BRAIN score predicts the probability of hematoma growth in ICH. This could be used to improve risk stratification for research and clinical practice.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial Registration—</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">http://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: NCT00226096 and NCT00716079. </jats:p> </jats:sec>
      3Scopus© Citations 117
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    Prognostic Significance of Hyperglycemia in Acute Intracerebral Hemorrhage The INTERACT2 Study
    (2016)
    Anubhav Saxena
    ;
    Craig S. Anderson
    ;
    Xia Wang
    ;
    Shoichiro Sato
    ;
    Hisatomi Arima
    <jats:sec> <jats:title>Background and Purpose—</jats:title> <jats:p>We aimed to determine associations of baseline blood glucose and diabetes mellitus with clinical outcomes in participants of the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT2).</jats:p> </jats:sec> <jats:sec> <jats:title>Methods—</jats:title> <jats:p>INTERACT2 was an international prospective, open, blinded end point, randomized controlled trial of 2839 patients with spontaneous intracerebral hemorrhage (&lt;6 hours) and elevated systolic blood pressure randomly assigned to intensive (target systolic blood pressure &lt;140 mm Hg) or guideline-based (systolic blood pressure &lt;180 mm Hg) BP management. Associations of hyperglycemia at presentation (&gt;6.5 mmol/L) and combined and separate poor outcomes of death and major disability (scores of 3–6, 3–5, and 6, respectively, on the modified Rankin scale) at 90 days were determined in logistic regression models.</jats:p> </jats:sec> <jats:sec> <jats:title>Results—</jats:title> <jats:p> In 2653 patients with available data, there were 1348 (61%) with hyperglycemia and 292 (11%) with diabetes mellitus. Associations of baseline blood glucose and poor outcome were strong and near continuous. After adjustment for baseline variables, the highest fourth (7.9–25.0 mmol/L) of blood glucose was significantly associated with combined poor outcome (adjusted odds ratio 1.35, 95% confidence interval 1.01–1.80; <jats:italic>P</jats:italic> trend 0.015). Diabetes mellitus also predicted poor outcome (adjusted odds ratio 1.46, 95% confidence interval 1.05–2.02; <jats:italic>P</jats:italic> =0.023), though more important for residual disability than death on separate analysis. </jats:p> </jats:sec> <jats:sec> <jats:title>Conclusions—</jats:title> <jats:p>Hyperglycemia and diabetes mellitus are independent predictors of poor outcome in patients with predominantly mild to moderate severity of intracerebral hemorrhage. These data support guideline recommendations for good glycemic control in patients with intracerebral hemorrhage.</jats:p> </jats:sec> <jats:sec> <jats:title>Clinical Trial Registration—</jats:title> <jats:p> URL: <jats:ext-link xmlns:xlink="http://www.w3.org/1999/xlink" ext-link-type="uri" xlink:href="http://www.clinicaltrials.gov">http://www.clinicaltrials.gov</jats:ext-link> . Unique identifier: NCT00716079. </jats:p> </jats:sec>
      5Scopus© Citations 118
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    Rapid Blood Pressure Lowering According to Recovery at Different Time Intervals after Acute Intracerebral Hemorrhage: Pooled Analysis of the INTERACT Studies
    (2015)
    Xia Wang
    ;
    Hisatomi Arima
    ;
    Rustam Al-Shahi Salman
    ;
    Mark Woodward
    ;
    Emma Heeley
    <jats:p>&lt;b&gt;&lt;i&gt;Background and Purpose:&lt;/i&gt;&lt;/b&gt; Early intensive blood pressure (BP) lowering has been shown to improve functional outcome in acute intracerebral hemorrhage (ICH), but the treatment effect is modest and without a clearly defined underlying explanatory mechanism. We aimed at more reliably quantifying the benefits of this treatment according to different time periods in the recovery of participants in the Intensive Blood Pressure Reduction in Acute Cerebral Hemorrhage Trial (INTERACT) studies. &lt;b&gt;&lt;i&gt;Methods:&lt;/i&gt;&lt;/b&gt; Pooled analysis of the pilot INTERACT1 (n = 404) and main INTERACT2 (n = 2,839) involving patients with spontaneous ICH (&lt;6 h) and elevated systolic BP (SBP 150-220 mm Hg) who were randomized to intensive (target SBP &lt;140 mm Hg) or guideline-recommended (target SBP &lt;180 mm Hg) BP lowering treatment. Treatment effects were examined according to repeated measures analysis of an ordinal (‘shift') across all 7 levels of the modified Rankin Scale (mRS) assessed during follow-up at 7, 28, and 90 days, post-randomization. Clinical trial registration information: http://www.clinicaltrials.gov, NCT00226096 and NCT00716079. &lt;b&gt;&lt;i&gt;Results:&lt;/i&gt;&lt;/b&gt; Intensive BP lowering resulted in a significant favorable distribution of mRS scores for better functioning (odds ratio 1.13, 95% confidence interval 1.00-1.26; p = 0.042) over 7, 28 and 90 days, and the effect was consistency for early (7-28 days) and later (28-90 days) time periods (p homogeneity 0.353). Treatment effects were also consistent across several pre-specified patient characteristic subgroups, with trends favoring those randomized early, and with higher SBP and milder neurological severity at baseline. &lt;b&gt;&lt;i&gt;Conclusions:&lt;/i&gt;&lt;/b&gt; Intensive BP lowering provides beneficial effects on physical functioning that manifests consistently through the early and later phases of recovery from ICH.</jats:p>
    Scopus© Citations 23  1
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    Applicability of ENCHANTED trial results to current acute ischemic stroke patients eligible for intravenous thrombolysis in England and Wales: Comparison with the Sentinel Stroke National Audit Programme registry
    (2019)
    Thompson G Robinson
    ;
    Benjamin D Bray
    ;
    Lizz Paley
    ;
    Nikola Sprigg
    ;
    Xia Wang
    <jats:sec><jats:title>Background</jats:title><jats:p> Randomized controlled trials provide high-level evidence, but the necessity to include selected patients may limit the generalisability of their results. </jats:p></jats:sec><jats:sec><jats:title>Methods</jats:title><jats:p> Comparisons were made of baseline and outcome data between patients with acute ischemic stroke (AIS) recruited into the alteplase-dose arm of the international, multi-center, Enhanced Control of Hypertension and Thrombolysis Stroke study (ENCHANTED) in the United Kingdom (UK), and alteplase-treated AIS patients registered in the UK Sentinel Stroke National Audit Programme (SSNAP) registry, over the study period June 2012 to October 2015. </jats:p></jats:sec><jats:sec><jats:title>Results</jats:title><jats:p> There were 770 AIS patients (41.2% female; mean age 72 years) included in ENCHANTED at sites in England and Wales, which was 19.5% of alteplase-treated AIS patients registered in the SSNAP registry. Trial participants were significantly older, had lower baseline neurological severity, less likely Asian, and had more premorbid symptoms, hypertension and atrial fibrillation. Although ENCHANTED participants had higher rates of symptomatic intracerebral hemorrhage than those in SSNAP, there were no differences in onset-to-treatment time, levels of disability (assessed by the modified Rankin scale) at hospital discharge, and mortality over 90 days between groups. </jats:p></jats:sec><jats:sec><jats:title>Conclusions</jats:title><jats:p> Despite the high level of participation, equipoise over the dose of alteplase among UK clinician investigators favored the inclusion of older, frailer, milder AIS patients in the ENCHANTED trial. </jats:p></jats:sec><jats:sec><jats:title>Clinical trial registration</jats:title><jats:p> Clinical Trial Registration-URL: http://www.clinicaltrials.gov . Unique identifier: NCT01422616 </jats:p></jats:sec>
      5Scopus© Citations 1