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  • 1
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 44, No. 9 ( 2013-09), p. 2381-2387
    Abstract: In a previous study, 0.3 and 0.45 mg/kg of intravenous recombinant tissue plasminogen activator (rt-PA) were safe when combined with eptifibatide 75 mcg/kg bolus and a 2-hour infusion (0.75 mcg/kg per minute). The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke–Enhanced Regimen (CLEAR-ER) trial sought to determine the safety of a higher-dose regimen and to establish evidence for a phase III trial. Methods— CLEAR-ER was a multicenter, double-blind, randomized safety study. Ischemic stroke patients were randomized to 0.6 mg/kg rt-PA plus eptifibatide (135 mcg/kg bolus and a 2-hour infusion at 0.75 mcg/kg per minute) versus standard rt-PA (0.9 mg/kg). The primary safety end point was the incidence of symptomatic intracranial hemorrhage within 36 hours. The primary efficacy outcome measure was the modified Rankin Scale (mRS) score ≤1 or return to baseline mRS at 90 days. Analysis of the safety and efficacy outcomes was done with multiple logistic regression. Results— Of 126 subjects, 101 received combination therapy, and 25 received standard rt-PA. Two (2%) patients in the combination group and 3 (12%) in the standard group had symptomatic intracranial hemorrhage (odds ratio, 0.15; 95% confidence interval, 0.01–1.40; P =0.053). At 90 days, 49.5% of the combination group had mRS ≤1 or return to baseline mRS versus 36.0% in the standard group (odds ratio, 1.74; 95% confidence interval, 0.70–4.31; P =0.23). After adjusting for age, baseline National Institutes of Health Stroke Scale, time to intravenous rt-PA, and baseline mRS, the odds ratio was 1.38 (95% confidence interval, 0.51–3.76; P =0.52). Conclusions— The combined regimen of intravenous rt-PA and eptifibatide studied in this trial was safe and provides evidence that a phase III trial is warranted to determine efficacy of the regimen. Clinical Trial Registration— URL: http://www.clinicaltrials.gov . Unique identifier: NCT00894803.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2013
    detail.hit.zdb_id: 1467823-8
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  • 2
    In: JAMA, American Medical Association (AMA), Vol. 325, No. 21 ( 2021-06-01), p. 2169-
    Type of Medium: Online Resource
    ISSN: 0098-7484
    RVK:
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2021
    detail.hit.zdb_id: 2958-0
    detail.hit.zdb_id: 2018410-4
    SSG: 5,21
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  • 3
    In: JAMA Neurology, American Medical Association (AMA), Vol. 80, No. 1 ( 2023-01-01), p. 99-
    Abstract: The Stroke of Known Cause and Underlying Atrial Fibrillation (STROKE AF) trial found that approximately 1 in 8 patients with recent ischemic stroke attributed to large- or small-vessel disease had poststroke atrial fibrillation (AF) detected by an insertable cardiac monitor (ICM) at 12 months. Identifying predictors of AF could be useful when considering an ICM in routine poststroke clinical care. Objective To determine the association between commonly assessed risk factors and poststroke detection of new AF in the STROKE AF cohort monitored by ICM. Design, Setting, and Participants This was a prespecified analysis of a randomized (1:1) clinical trial that enrolled patients between April 1, 2016, and July 12, 2019, with primary follow-up through 2020 and mean (SD) duration of 11.0 (3.0) months. Eligible patients were selected from 33 clinical research sites in the US. Patients had an index stroke attributed to large- or small-vessel disease and were 60 years or older or aged 50 to 59 years with at least 1 additional stroke risk factor. A total of 496 patients were enrolled, and 492 were randomly assigned to study groups (3 did not meet inclusion criteria, and 1 withdrew consent). Patients in the ICM group had the index stroke within 10 days before insertion. Data were analyzed from October 8, 2021, to January 28, 2022. Interventions ICM monitoring vs site-specific usual care (short-duration external cardiac monitoring). Main Outcomes and Measures The ICM device automatically detects AF episodes 2 or more minutes in length; episodes were adjudicated by an expert committee. Cox regression multivariable modeling included all parameters identified in the univariate analysis having P values & amp;lt;.10. AF detection rates were calculated using Kaplan-Meier survival estimates. Results The analysis included the 242 participants randomly assigned to the ICM group in the STROKE AF study. Among 242 patients monitored with ICM, 27 developed AF (mean [SD] age, 66.6 [9.3] years; 144 men [60.0%]; 96 [40.0%] women). Two patients had missing baseline data and exited the study early. Univariate predictors of AF detection included age (per 1-year increments: hazard ratio [HR], 1.05; 95% CI, 1.01-1.09; P  = .02), CHA 2 DS 2 -VASc score (per point: HR, 1.54; 95% CI, 1.15-2.06; P  = .004), chronic obstructive pulmonary disease (HR, 2.49; 95% CI, 0.86-7.20; P  = .09), congestive heart failure (CHF; with preserved or reduced ejection fraction: HR, 6.64; 95% CI, 2.29-19.24; P   & amp;lt; .001), left atrial enlargement (LAE; HR, 3.63; 95% CI, 1.55-8.47; P  = .003), QRS duration (HR, 1.02; 95% CI, 1.00-1.04; P  = .04), and kidney dysfunction (HR, 3.58; 95% CI, 1.35-9.46; P  = .01). In multivariable modeling (n = 197), only CHF (HR, 5.06; 95% CI, 1.45-17.64; P  = .05) and LAE (HR, 3.32; 1.34-8.19; P  = .009) remained significant predictors of AF. At 12 months, patients with CHF and/or LAE (40 of 142 patients) had an AF detection rate of 23.4% vs 5.0% for patients with neither (HR, 5.1; 95% CI, 2.0-12.8; P   & amp;lt; .001). Conclusions and Relevance Among patients with ischemic stroke attributed to large- or small-vessel disease, CHF and LAE were associated with a significantly increased risk of poststroke AF detection. These patients may benefit most from the use of ICMs as part of a secondary stroke prevention strategy. However, the study was not powered for clinical predictors of AF, and therefore, other clinical characteristics may not have reached statistical significance. Trial Registration ClinicalTrials.gov Identifier: NCT02700945
    Type of Medium: Online Resource
    ISSN: 2168-6149
    Language: English
    Publisher: American Medical Association (AMA)
    Publication Date: 2023
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  • 4
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 54, No. 3 ( 2023-03), p. 831-839
    Abstract: Stroke is a leading cause of long-term disability. Greater rehabilitation therapy after stroke is known to improve functional outcomes. This study examined therapy doses during the first year of stroke recovery and identified factors that predict rehabilitation therapy dose. Methods: Adults with new radiologically confirmed stroke were enrolled 2 to 10 days after stroke onset at 28 acute care hospitals across the United States. Following an initial assessment during acute hospitalization, the number of physical therapy, occupational therapy, and speech therapy sessions were determined at visits occurring 3, 6, and 12 months following stroke. Negative binomial regression examined whether clinical and demographic factors were associated with therapy counts. False discovery rate was used to correct for multiple comparisons. Results: Of 763 patients enrolled during acute stroke admission, 510 were available for follow-up. Therapy counts were low overall, with most therapy delivered within the first 3 months; 35.0% of patients received no physical therapy; 48.8%, no occupational therapy, and 61.7%, no speech therapy. Discharge destination was significantly related to cumulative therapy; the percentage of patients discharged to an inpatient rehabilitation facility varied across sites, from 0% to 71%. Most demographic factors did not predict therapy dose, although Hispanic patients received a lower cumulative amount of physical therapy and occupational therapy. Acutely, the severity of clinical factors (grip strength and National Institutes of Health Stroke Scale score, as well as National Institutes of Health Stroke Scale subscores for aphasia and neglect) predicted higher subsequent therapy doses. Measures of impairment and function (Fugl-Meyer, modified Rankin Scale, and Stroke Impact Scale Activities of Daily Living) assessed 3 months after stroke also predicted subsequent cumulative therapy doses. Conclusions: Rehabilitative therapy doses during the first year poststroke are low in the United States. This is the first US-wide study to demonstrate that behavioral deficits predict therapy dose, with patients having more severe deficits receiving higher doses. Findings suggest directions for identifying groups at risk of receiving disproportionately low rehabilitation doses.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2023
    detail.hit.zdb_id: 1467823-8
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  • 5
    Online Resource
    Online Resource
    Ovid Technologies (Wolters Kluwer Health) ; 2003
    In:  Stroke Vol. 34, No. 1 ( 2003-01), p. 134-137
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 34, No. 1 ( 2003-01), p. 134-137
    Abstract: Background and Purpose— Early identification of stroke patients in need of rehabilitation or long-term nursing facility (NF) care may promote more efficient use of health care resources and lead to better outcomes. The NIH Stroke Scale (NIHSS) is an attractive candidate predictor of disposition because it is widely used, is easily learned, and can be performed rapidly on admission. Methods— We present a retrospective study of stroke patients admitted within 24 hours of symptom onset to a university hospital from March through June 2000. Medical records were reviewed for demographic information, stroke type, prestroke living arrangement and independence, initial NIHSS, and medical complications during hospitalization. Results— Among 94 patients evaluated during the study period, 59% were discharged home, 30% to rehabilitation, and 11% to NF. In multivariate analyses, disposition was associated only with initial NIHSS. For each 1-point increase in NIHSS, the likelihood of going home was significantly reduced (odds ratio, 0.79; 95% CI, 0.70 to 0.89, P 〈 0.001). Categorization of NIHSS was also predictive of disposition, with NIHSS ≤5 being most strongly associated with discharge home, NIHSS 6 to 13 with rehabilitation, and NIHSS 〉 13 with NF ( P 〈 0.001). Although no other baseline characteristics predicted disposition, major medical complications during hospitalization tended to reduce the odds of going home (odds ratio, 0.30; 95% CI, 0.08 to 1.0, P =0.07). Conclusion— The NIHSS predicts postacute care disposition among stroke patients. Predicting disposition on the first day of admission may facilitate the time-consuming and costly process of securing a bed at rehabilitation or NF, and perhaps decrease unnecessary length of stay in acute care settings.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2003
    detail.hit.zdb_id: 1467823-8
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  • 6
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 30, No. 8 ( 1999-08), p. 1534-1537
    Abstract: Background and Purpose —The aim of our study was to determine whether the National Institutes of Health Stroke Scale (NIHSS) can be estimated retrospectively from medical records. The NIHSS is a quantitative measure of stroke-related neurological deficit with established reliability and validity for use in prospective clinical research. Recently, retrospective observational studies have estimated NIHSS scores from medical records for quantitative outcome analysis. The reliability and validity of estimation based on chart review has not been determined. Methods —Thirty-nine patients were selected because their NIHSS scores were formally measured at admission and discharge. Handwritten notes from medical records were abstracted and NIHSS scores were estimated by 6 raters who were blinded to the actual scores. Estimated scores were compared among raters and with the actual measured scores. Results —Interrater reliability was excellent, with an intraclass correlation coefficient of 0.82. Scores were well calibrated among the 6 raters. Estimated NIHSS scores closely approximated the actual scores, with a probability of 0.86 of correctly ranking a set of patients according to 5-point interval categories (as determined by the area under the receiver-operator characteristic curve). Patients with excellent outcomes (NIHSS score of ≤5) could be identified with sensitivity of 0.72 and specificity of 0.89. There were no significant differences between these parameters at admission and discharge. Conclusions —For the purposes of retrospective studies of acute stroke outcome, the NIHSS can be abstracted from medical records with a high degree of reliability and validity.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 1999
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  • 7
    Online Resource
    Online Resource
    Ovid Technologies (Wolters Kluwer Health) ; 2012
    In:  Stroke Vol. 43, No. 5 ( 2012-05), p. 1446-1447
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 43, No. 5 ( 2012-05), p. 1446-1447
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2012
    detail.hit.zdb_id: 1467823-8
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  • 8
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 40, No. 9 ( 2009-09), p. 3067-3072
    Abstract: Background and Purpose— A number of factors have been associated with postthrombolysis intracerebral hemorrhage, but these have varied across studies. Methods— We examined patients with acute ischemic stroke treated with intravenous tissue plasminogen activator within 3 hours of symptom onset who were enrolled in the placebo arms of 2 trials (Stroke-Acute Ischemic NXY Treatment [SAINT] I and II Trials) of a putative neuroprotectant. Early CT changes were graded using the Alberta Stroke Program Early CT Score (ASPECTS). Post–tissue plasminogen activator symptomatic intracerebral hemorrhage was defined as a worsening in National Institutes of Health Stroke Scale of ≥4 points within 36 hours with evidence of hemorrhage on follow-up neuroimaging. Good clinical outcome was defined as a modified Rankin scale of 0 to 2 at 90 days. Results— Symptomatic intracerebral hemorrhage occurred in 5.6% of 965 patients treated with tissue plasminogen activator. In multivariable analysis, symptomatic intracerebral hemorrhage was increased with baseline antiplatelet use (single antiplatelet: OR, 2.04, 95% CI, 1.07 to 3.87, P =0.03; double antiplatelet: OR, 9.29, 3.28 to 26.32, P 〈 0.001), higher National Institutes of Health Stroke Scale score (OR, 1.09 per point, 1.03 to 1.15, P =0.002), and CT changes defined by ASPECTS (ASPECTS 8 to 9: OR, 2.26, 0.63 to 8.10, P =0.21; ASPECTS ≤7: OR, 5.63, 1.66 to 19.10, P =0.006). Higher National Institutes of Health Stroke Scale was associated with decreased odds of good clinical outcome (OR, 0.82 per point, 0.79 to 0.85, P 〈 0.001). There was no relationship between baseline antiplatelet use or CT changes and clinical outcome. Conclusions— Along with higher National Institutes of Health Stroke Scale and extensive early CT changes, baseline antiplatelet use (particularly double antiplatelet therapy) was associated with an increased risk of post–tissue plasminogen activator symptomatic intracerebral hemorrhage. Of these factors, only National Institutes of Health Stroke Scale was associated with clinical outcome.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2009
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  • 9
    Online Resource
    Online Resource
    Ovid Technologies (Wolters Kluwer Health) ; 2011
    In:  Stroke Vol. 42, No. 4 ( 2011-04), p. 1074-1080
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 42, No. 4 ( 2011-04), p. 1074-1080
    Abstract: Emergency department (ED) crowding occurs when demands for ED care exceed the supply of available resources. Prior studies have shown that ED crowding is associated with a delay in provision of critical ED services, but the impact of ED crowding on acute stroke care has not been extensively studied. Methods— We conducted a retrospective study of patients who presented to the ED with acute stroke symptoms (ischemic stroke, transient ischemic attack, intracerebral hemorrhage) at 2 hospitals. All patients with active stroke symptoms who presented within 3 hours were included and a random sample of patients with symptoms 〉 3 hours was used for comparison. The association between ED crowding measures (waiting room number, ED occupancy, number of admitted patients, and total patient hours) and time to head CT order, completion, and interpretation, and time to administration of thrombolysis was determined. Results— Of 253 patients presenting with acute stroke symptoms ≤3 hours from symptom onset, 52 (21%) received thrombolysis. A random comparison group of 253 patients with symptoms 〉 3 hours was identified. There was no significant association between ED crowding and delays in CT timing or thrombolysis in patients with symptoms ≤3 hours. Several measures of ED crowding were associated with prolonged times to CT order and completion in patients with symptoms 〉 3 hours. Conclusions— ED crowding was not associated with care delays in thrombolysis-eligible patients with stroke. However, those with symptoms 〉 3 hours do experience CT delays at higher levels of ED crowding.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2011
    detail.hit.zdb_id: 1467823-8
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  • 10
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 43, No. suppl_1 ( 2012-02)
    Abstract: Background and Purpose: Newly defined subclasses of antiphospholipid antibodies (aPLs) have been associated with thrombotic and atherosclerotic vascular events. We aimed to determine if they predict outcome after TIA. Methods: Detailed clinical data and blood samples were obtained prospectively from subjects with TIA hospitalized 〈 48 hours from symptom onset. In a retrospective analysis standard aPLs, anti-cardiolipin (ACL) and β-2-glycoprotein-1 (β2GP1), and newer aPLs, anti-phosphatidylserine-prothrombin (aPS-PT), β2GP1 D4/5 subunit and β2GP1 D1 subunit, were measured by ELISA. The primary outcome was a composite endpoint of stroke or death within 90 days or identification of a high-risk stroke mechanism (defined as 〉 50% stenosis in a vessel referable to symptoms or cardioembolism warranting anticoagulation). A secondary outcome was the presence of clinical or sub-clinical atherosclerosis. Results: Over 4.5 years, 167 patients were enrolled. Mean age was 62±14 years; 55% were female. Mean time from symptom onset to blood sampling was 26.2 ± 12.7 hours. Overall, 41 patients (25%) had the composite endpoint: 25 (15%) with a 〉 50% stenosis, 14 (8%) with cardioembolism and 8 (5%) with clinical events (5 strokes, 3 deaths). The results of aPL testing using predefined cut-points to define positivity are summarized in the table . Using a cutoff of 30 units aPS-PT IgG antibodies were significantly associated with stroke/death (OR 17.3 95% CI 2.4-123.8 p=0.004) with a trend towards an association with the composite endpoint (OR 4.9 95% CI 0.8-30.4 p=0.09). In multivariate analysis adjusting for ABCD2 score, aPS-PT IgG remained associated with stroke/death (OR 16.6 95% CI 2.1-133.7 p=0.008). Using a data derived cut-off of 20 units (∼95% percentile within study population) aPS-PT IgG antibodies were significantly associated with stroke/death (OR 7.2 95% CI 1.2-42.5 p=0.03) and the composite endpoint (OR 4.2 95% CI 1.1-16.6 p=0.04). After adjusting for ABCD2 score, the association with stroke/death remained significant (OR 6.1 95% CI 1.0-38.5 p=0.05) and the composite endpoint approached significance (OR 3.8 95% CI 0.9-15.4 p=0.06). Elevated aPS-PT IgG levels occurred more frequently in subjects with clinical or sub-clinical atherosclerosis than those without (9% vs 0%, p=0.012). Other aPLs were not associated with atherosclerosis. Conclusion: In contrast to other aPLs, anti-phosphatidylserine-prothrombin IgG antibodies are elevated in high-risk TIA patients.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2012
    detail.hit.zdb_id: 1467823-8
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