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Unwitnessed stroke: impact of different onset times on eligibility into stroke trials.

ABSTRACT: Patients with unwitnessed stroke represent >25% of all strokes. Clinical trials enrolling patients with unwitnessed stroke onset have conservatively used last known normal (LKN) as the time of stroke onset. We explored the impact of alternative methods of selecting onset time in unwitnessed strokes on eligibility into an acute stroke therapeutic trial using a representative sample of acute stroke subjects.We analyzed data on 641 consecutive patients with suspected stroke presenting to our hospital between January 2007 and July 2008. Time of onset was calculated by 3 methods: (1) LKN, (2) first known abnormal (FKA), and (3) midpoint between LKN and FKA. Subjects with incomplete data or a final diagnosis of nonischemic stroke were excluded. Rates of trial eligibility based on different onset times were compared for several inclusion time windows.Onset time was known in 440 subjects (69%). Of the remaining 201 patients with unwitnessed onset, 114 (57%) were "wake-up" strokes. Among unwitnessed stroke subjects, eligibility increased from 18% using LKN to 57% using FKA at 4.5 hours and 42% to 81% at 9 hours (P < .001), respectively. Overall enrollment eligibility for the full cohort increased from 36% to 48% at 4.5 hours and 61% to 73% at 9 hours (P < .001), respectively.Given potential advantages in safety evaluation and the historical inadequate enrollment rates in acute stroke trials, alternative onset time definitions, perhaps in combination with advanced neuroimaging methods (e.g., fluid-attenuated inversion recovery-diffusion-weighted imaging mismatch), should be considered for early-phase trials.

SUBMITTER: Maas MB

PROVIDER: S-EPMC3718254 | biostudies-other | 2013 Apr

REPOSITORIES: biostudies-other

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Unwitnessed stroke: impact of different onset times on eligibility into stroke trials.

Maas Matthew B MB Singhal Aneesh B AB

Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association 20110913 3

<h4>Background</h4>Patients with unwitnessed stroke represent >25% of all strokes. Clinical trials enrolling patients with unwitnessed stroke onset have conservatively used last known normal (LKN) as the time of stroke onset. We explored the impact of alternative methods of selecting onset time in unwitnessed strokes on eligibility into an acute stroke therapeutic trial using a representative sample of acute stroke subjects.<h4>Methods</h4>We analyzed data on 641 consecutive patients with suspec ...[more]

PMID: 21917477

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Project description:BackgroundThe clinical characteristics and imaging findings of acute pancreatitis (AP) are different across the various etiologies, the results are conflicting, and their time from symptom onset to imaging varies. The imaging findings of different etiologies at different onset times are unclear. This study aimed to investigate the computed tomography (CT) characteristics of AP based on different etiologies at different onset times.MethodsPatients who underwent plain and contrast-enhanced computed tomography (CECT) for the first attack of AP in 3 hospitals (Affiliated Hospital of North Sichuan Medical College, Chinese People's Liberation Army Western Theater General Hospital, and Suining Central Hospital) from 2015 to 2019 were recruited. According to the different etiologies of AP, the patients were divided into 5 subgroups: biliary AP (n=591), alcoholic AP (n=267), hypertriglyceridemic AP (n=258), mixed causes subgroups (n=199), and "other/idiopathic" AP (n=545). According to the time from onset to CT examination (e.g., 1-3, 4-7, 8-14, 15-28, and >28 days), the onset time was divided into 5 respective phases (I-V). The CT characteristics and clinical and laboratory features were retrospectively reviewed and compared among the different etiology subgroups and onset time.ResultsThe positive rate of CT findings in AP diagnosis based on CECT was 96.7% (1,860/1,924). Necrotizing pancreatitis (NP) occurred in 33.2% (617/1,860) of AP patients with positive CECT findings. Among patients with NP, local complications and severe AP of the modified CT severity index (MCTSI) increased over time in those with biliary AP from 17.1%, 25.2%, and 20.0% in Phase I to 42.9%, 44.0%, and 39.7% in Phase IV [all P<0.05, 95% confidence interval (CI): 0.15 to 0.52, 0.28 to 0.63, and 0.18 to 0.82, respectively]. In contrast, NP, local complications and severe AP of MCTSI in those with hypertriglyceridemic AP decreased over time from 24.3%, 22.5%, and 22.7% in Phase I to 1.3%, 1.2%, and 1.9% in Phase V (all P<0.05, 95% CI: 3.20 to 181.74, 3.31 to 175.74, and 2.00 to 120.78, respectively).ConclusionsThe proportion of NP was 33.2% of positive CECT findings. There may be differences in the CT and clinical manifestations of the different etiologies, and those differences may be related to the onset time.

Project description:BackgroundThe optimal dose of tenecteplase vs. alteplase for acute ischemic stroke (AIS) has yet to be established. Therefore, we included the latest randomized controlled trials (RCT) to assess the efficacy and safety of different doses of tenecteplase vs. alteplase for AIS within 4.5 hours of symptom onset.MethodsLiterature was searched in PubMed, Cochrane Library, Embase, Web of Science, and clinical trial registries until February 12, 2023. Odds ratios (OR) with 95% credible intervals (CrI) were estimated using Bayesian network meta-analysis (NMA). Treatments were ranked based on efficacy and safety using the surface under the cumulative ranking curve (SUCRA).ResultsEleven RCTs with 5,475 patients were included. Tenecteplase 0.25 mg/kg and alteplase 0.9 mg/kg had significantly higher rates of excellent functional outcome (tenecteplase: OR, 1.85; 95% CrI, 1.44-2.37; alteplase: OR, 1.60; 95% CrI, 1.29-1.97) and good functional outcome (tenecteplase: OR, 1.54; 95% CrI, 1.19-1.98; alteplase: OR, 1.40; 95% CrI, 1.14-1.74) than placebo, despite an increased risk of symptomatic intracranial hemorrhage. Furthermore, the NMA (OR, 1.16; 95% CrI, 1.01-1.33) and the pairwise meta-analysis (OR, 1.16; 95% CI, 1.02-1.33; P = 0.03) indicated that tenecteplase 0.25 mg/kg was superior to alteplase 0.9 mg/kg in excellent functional outcome. Alteplase 0.9 mg/kg (OR, 2.54; 95% CrI, 1.45-8.08) significantly increased the risk of any intracranial hemorrhage compared with placebo. SUCRA results demonstrated that tenecteplase 0.25 mg/kg ranked first and tenecteplase 0.4 mg/kg ranked last in efficacy outcomes.ConclusionsThe NMA indicated that tenecteplase 0.25 mg/kg and alteplase 0.9 mg/kg are safe and significantly improve clinical outcomes in patients with AIS within 4.5 h of symptom onset. Furthermore, tenecteplase 0.25 mg/kg provides more benefit and has the potential to replace alteplase 0.9 mg/kg in AIS treatment.Systematic review registrationhttps://www.crd.york.ac.uk/PROSPERO/index.php, identifier: CRD42022343948.

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Unwitnessed stroke: impact of different onset times on eligibility into stroke trials.

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Unwitnessed stroke: impact of different onset times on eligibility into stroke trials.

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