GLORIA

GEOMAR Library Ocean Research Information Access

Your email was sent successfully. Check your inbox.

An error occurred while sending the email. Please try again.

Proceed reservation?

Export
  • 1
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 46, No. suppl_1 ( 2015-02)
    Abstract: Background and Objectives: A significant number of ischemic strokes are noticed upon awakening and are not candidates for intravenous recombinant tissue plasminogen activator (rtPA) due to 〉 3 hours from last seen normal (LSN). We tested the safety of rtPA in a multicenter, single-arm, prospective, open-label study (NCT01183533) of rtPA in patients with wake-up stroke (WUS). Methods: We aimed to enroll 40 WUS patients with disabling deficits. Patients were 18-80; NIHSS ≤25; and selected only on the appearance of non-contrast CT (i.e., 〈 1/3 MCA territory hypodensity). Standard dose (0.9mg/kg) intravenous rtPA had to be started ≤3 hours of awakening. The primary safety outcome was symptomatic intracerebral hemorrhage (ICH) with pre-planned stopping rules and data safety board oversight. Other endpoints included: asymptomatic ICH, clinical improvement in NIHSS and 90-day modified Rankin Scale score (mRS). Results: Between 10/2010 and 10/2013, all pre-planned patients were enrolled. Four patients (10%) were subsequently determined to be mimics. Baseline characteristics, treatment and outcome data are shown in the table. No symptomatic ICH or parenchymal hematomas occurred. Conclusion: Intravenous thrombolysis appears to be safe in WUS patients selected by non-contrast CT. A randomized effectiveness trial appears feasible using a similar, pragmatic design.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2015
    detail.hit.zdb_id: 1467823-8
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 2
    In: International Journal of Stroke, SAGE Publications, Vol. 13, No. 3 ( 2018-04), p. 321-327
    Abstract: Mobile stroke units speed treatment for acute ischemic stroke, thereby possibly improving outcomes. Aim To compare mobile stroke unit and standard management clinical outcomes, healthcare utilization, and cost-effectiveness in tissue plasminogen activator-eligible acute ischemic stroke patients calling 911. Sample size 693. Eighty percent power with 0.05 type I error rate to detect a difference of 0.09 in mean utility-weighted modified Rankin scale between groups. Design Phase III, multicenter, prospective cluster-randomized (mobile stroke unit versus standard management weeks) comparative effectiveness study in tissue plasminogen activator-eligible patients. Outcomes Primary: Ninety-day mean utility-weighted modified Rankin scale. Coprimary: cost-effectiveness based on EQ5D quality of life and one year poststroke costs. Analysis Two-sample t-test and linear regression adjusting for covariates; incremental cost-effectiveness ratio and net benefit regression. Results As of March 2017, 288 tissue plasminogen activator-eligible patients have been enrolled (173 in the mobile stroke unit arm and 115 in the standard management arm). Two new centers start in early 2017 with target end of recruitment September 2019. Conclusion This is the first randomized study to test for disability, healthcare utilization, and cost-effectiveness of a mobile stroke unit. The progress of the study suggests that it is feasible. Management of tissue plasminogen activator eligible acute ischemic stroke patients by a mobile stroke unit could potentially result in less disability and healthcare utilization, and be cost effective. Mobile stroke units are very costly. This trial may determine if the fixed cost can be justified by a reduction in disability and healthcare utilization. Clinical Trial Registration NCT02190500.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2018
    detail.hit.zdb_id: 2211666-7
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 3
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 44, No. suppl_1 ( 2013-02)
    Abstract: Introduction: We aimed to compare established and new CSCs with respect to treatment rates and safety over time. We also hypothesized that a ceiling effect would be observed prompting consideration of how additional patients could be brought to treatment. Methods: Data were assembled from consecutive ischemic stroke patients admitted to one established (Site 1 with a multisite telemedicine system) and two start-up academic CSCs (Sites 2 and 3 without telemedicine) with vascular neurology fellowship-trained leadership and the launch of 24/7/365 services. All centers met Brain Attack Coalition criteria for CSCs. Patient volume, IV tPA and sICH rates were compared over time. Results: In 2005-2011, 4017 ischemic strokes were admitted to Site 1. After the start of new leadership (2008-2011), Site 2 had 912 admissions and Site 3 had 1499 admissions. After very rapid initial growth (Figure), all three centers continued to increase stroke admission volumes by factors ranging from 1.8 to 3.6. However, IV tPA treatment rates increased at a steadier pace (1.05-1.6), diminishing at times but still ahead of published national average rates. No significant increase in sICH rates occurred (p=0.49, p=0.75). The established center treated more patients within the 3 hr time window (75% vs 61% vs 59%; p≤0.007). Conclusions: The launch of 24/7/365 vascular neurology driven CSCs resulted in rapid and safe increases in IV tPA treatment well above average rates reported nationally. Start-up CSCs will require telemedicine and continuing outreach to more spoke sites to achieve higher and earlier treatment rates. The reported growth in stroke admissions is not paralleled with equally proportionate increase in treatment rates across established and start-up centers suggesting a ceiling effect, and reasons for this effect including proliferation of PSCs with low treatment rates deserve further investigation.
    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
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 4
    In: Circulation, Ovid Technologies (Wolters Kluwer Health), Vol. 127, No. suppl_12 ( 2013-03-26)
    Abstract: Background: Previous research has indicated that women and Blacks have worse outcomes following acute ischemic stroke (AIS). Little research has been done to investigate the influence of race in the presentation and outcome specifically among women with AIS. Methods: AIS patients presenting to two centers in the Stroke Belt (2004-2011) were identified by prospective registries. Men, women who did not identify as Black or White, and in-hospital strokes were excluded. Patient demographics, clinical characteristics, admission National Institutes of Health Stroke Scale (NIHSS) scores, favorable discharge disposition (home or inpatient rehab), time from last seen normal to ED arrival, and functional discharge outcome as measured by the modified Rankin Scale (mRS) were investigated. Patients were divided into 3 groups: (1) not treated with IV t-PA, (2) treated with IV t-PA within 3 hours of symptom onset, and (3) treated with IV t-PA beyond 3 hours. Results: Of the 8763 patients screened, 2217 women met the study criteria (59% White). White women were older (72 vs. 64; p 〈 0.0001), had higher percentage of atrial fibrillation (24% vs. 11%; p 〈 0.0001), lower percentage of diabetes (30% vs. 40%, p 〈 0.0001), lower percentage of hypertension (73% vs. 84%; p 〈 0.0001) and had a higher baseline NIHSS (9 vs. 7; p=0.0045) Administration of tPA was significantly less among Black women (36% Whites vs. 27% Blacks, p 〈 0.0001). White women are at increased odds of receiving tPA treatment (OR=1.43, 95%CI 1.17-1.75, p=0.0005), and remain at increased odds after adjusting for age, baseline NIHSS, time from last seen normal and glucose (OR 1.42, 95% CI 1.11-1.81, p=00044). Despite the significant difference in treatment with IV tPA, White women had increased odds of having a poor functional outcome (OR=1.2, 95% CI 1.02-1.439,p=0.0250) and unfavorable discharge disposition (OR 1.4, 95% CI 1.18-1.67, p=0.0001), but stratifying by tPA treatment groups, race was not found to be predictive of outcome after adjusting for known confounders (i.e., age, glucose, baseline NIHSS, time from last seen normal). Discussion: Unlike data from previous studies, Black women who presented to these two centers with AIS had less severe neurologic deficits on presentation compared to their White counterparts. Despite differences in the proportion of Blacks and Whites treated with IV tPA, race was not significantly associated with outcome. In our study, age and stroke severity_not race_were the primary predictors for poor outcome.
    Type of Medium: Online Resource
    ISSN: 0009-7322 , 1524-4539
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2013
    detail.hit.zdb_id: 1466401-X
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 5
    In: BMC Neurology, Springer Science and Business Media LLC, Vol. 13, No. 1 ( 2013-12)
    Type of Medium: Online Resource
    ISSN: 1471-2377
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2013
    detail.hit.zdb_id: 2041347-6
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 6
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 43, No. suppl_1 ( 2012-02)
    Abstract: Background and Purpose Early hematoma expansion (EHE) has been described in the first 48 hours. SHRINC is a phase 2 prospective safety trial whose primary objective is to assess the safety of pioglitazone (PIO) when administered to patients with spontaneous intracerebral hemorrhage (SICH) compared to standard care. A secondary objective is to characterize the changes in hematoma resolution and expansion over time. This prospective study addresses the natural history, clinical impact, and associated risk factors of late hematoma expansion (LEX) by serial magnetic resonance imaging (MRI) after SICH. Methods SHRINC aims to enroll 78 subjects between the ages of 18-80 with a SICH of ≥ 5 ml. This analysis includes the first 42 patients enrolled. Four subjects were excluded because they did not have an MRI after day 2. A baseline CTH was performed followed by an MRI within 24 hours of symptom onset. Hematoma volume (Hv) was measured on FLAIR sequences using a previously published semi-automated range of interest method. LEX was defined as an increase in Hv 〉 0.5 ml after the 48 hour MRI. Factors associated with LEX were evaluated with logistic regression. Longitudinal analyses were used for measurements taken over the follow up period. Results: Ten (26.3%) of 38 subjects displayed LEX. Eight subjects had LEX between day 2 to 14, and 4 between days 14 to 28. The median initial Hv was 16.1cc in LEX patients and 24.1cc in those without expansion (NEX) (p=0.23). Lower platelet counts (p=0.04) and BUN levels (p=0.03) were associated with LEX in univariate analysis. Multivariate analysis suggested that those with higher BUN levels were less likely to have LEX (OR=0.81; 95%CI 0.65-0.99). Blood pressure and EHE (13.2%) were not associated with LEX. There was no difference in neurological worsening (NIHSS increase ≥ 4), 6 month mRS or death between LEX and NEX. Conclusion: This is the first prospective study to address LEX with serial MRIs. LEX occurs between day 2 to 14 and day 14 to 28. Elevated BUN levels may decrease the likelihood of LEX. A limitation of our study is that the effect of PIO on LEX could not be evaluated because SHRINC is a blinded trial. Further studies will assess the pathophysiology of LEX and its potential implications in clinical trials evaluating hematoma growth and resolution.
    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
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 7
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 46, No. suppl_1 ( 2015-02)
    Abstract: Background: Few studies have reported electrocardiographic (ECG) changes in patients with intracerebral hemorrhage (ICH). We performed a randomized controlled trial evaluating the safety of pioglitazone (PIO) versus placebo in patients with ICH (NCT00827892). Cardiac toxicity was evaluated with serial ECG. Methods: Patients enrolled into the Safety of Pioglitazone for Hematoma Resolution in ICH (SHRINC) trial were randomly allocated 1:1 to either placebo or PIO. Patients received escalating doses of PIO daily for 3 days (high-dose phase) beginning within 24 hours of symptom onset, followed by a 30mg maintenance dose for the duration of treatment. Serial ECGs were performed at baseline and on days 1, 2, 3 and 90. Zero inflated Poisson regression was used to model the relationship between treatment with PIO and the likelihood of observing new important ECG findings during the high-dose phase. Results: A total of 84 patients were enrolled in SHRINC (42 PIO, 42 placebo). At baseline, 60% of patients in both groups had important abnormal ECG findings, the most common being prolonged QT (Table 1a). During the high-dose phase, 51% in the PIO group and 46% in the placebo group developed at least one new important abnormal ECG finding (Table 1b). In multivariable analysis, after controlling for age, diabetes, baseline PTT, baseline systolic and diastolic blood pressure, PIO was not associated with the likelihood of developing any new important abnormal ECG findings, Rate Ratio 1.27, 95% CI (0.71, 2.28), p=0.42. Conclusions: ECG findings in this cohort of ICH patients were dynamic in the first 72 hours with most patients having abnormal ECGs at baseline and almost half of the cohort developing new findings. The addition of a placebo group allowed us to incorporate the natural history of ICH in our analysis to more clearly understand the effect of PIO. We did not find cardiac toxicity due to PIO as evidenced by ECG changes during the follow up period.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2015
    detail.hit.zdb_id: 1467823-8
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 8
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 44, No. suppl_1 ( 2013-02)
    Abstract: Background and Objectives: Early neurological improvement (ENI) at 2-hours post thrombolysis has recently been proposed to most accurately predict recanalization when repeat vascular imaging is not available. However, these studies analyzed recanalization at a delayed time point (≥24 hours). The Argatroban tPA Stroke Study (ARTSS-1), is a recently completed NIH sponsored, Phase IIa, prospective, open-label, safety and activity study of Argatroban and rtPA in patients with ischemic stroke ( NCT00268762 ). We hypothesized 2-hour recanalization correlates with ENI (NIHSS improvement of 20% or greater from baseline). Methods: A total of 65 patients with intracranial large vessel occlusive disease were given standard dose (0.9mg/kg) tPA and a 100 μg/kg bolus of argatroban followed by infusion of 1 μg/kg per minute for 48 hours adjusted to a PTT of 1.75 times baseline. Pre-tPA vessel imaging using TCD or CTA confirmed intracranial occlusions. A multivariate logistic regression tested whether recanalization at 2 hours was associated with ENI after controlling for age, NIHSS, clot location (ICA, MCA or vertebrobasilar). We analyzed whether patients with ENI had statistically significant greater odds of an excellent mRS (0 or 1) at day 7. Results: Recanalization data was available for 47 patients at 2-hours. ENI occurred at 2-hours in 46% patients. Patients with any recanalization (complete or partial) at 2-hours were more likely to experience ENI (OR 3.4; 95% CI 0.71-16.6, p=0.124). This association strengthened when 2-hour complete recanalization was analyzed (OR 5.4; 95% CI 0.98-29.2, p=0.053). In an unadjusted analysis, patients with ENI at 2-hours were five times more likely to have excellent mRS outcomes at day 7 (OR 4.7; 95% CI 1.4-15.6, p=0.01). In the adjusted model, the association remained significant (OR 3.8; 95%CI 1.1-13.4, p=0.041). Conclusion: Two-hour recanalization is predictive of early neurological improvement and better early clinical outcomes in patients treated with combination Argatroban and tPA. A randomized, controlled clinical trial of this promising adjunctive therapy is warranted and ongoing (ARTSS-2 trial, NCT01464788 ).
    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
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 9
    Online Resource
    Online Resource
    Informa UK Limited ; 2006
    In:  Expert Review of Cardiovascular Therapy Vol. 4, No. 3 ( 2006-05), p. 301-318
    In: Expert Review of Cardiovascular Therapy, Informa UK Limited, Vol. 4, No. 3 ( 2006-05), p. 301-318
    Type of Medium: Online Resource
    ISSN: 1477-9072 , 1744-8344
    Language: English
    Publisher: Informa UK Limited
    Publication Date: 2006
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
  • 10
    In: Stroke, Ovid Technologies (Wolters Kluwer Health), Vol. 45, No. suppl_1 ( 2014-02)
    Abstract: Background and Objectives: Peroxisome proliferator activated receptor-gamma agonists, such as pioglitazone (PIO) enhanced hematoma resolution and improved functional recovery in our animal model of intracerebral hemorrhage (ICH). We conducted a translational Phase II randomized, controlled clinical trial to determine the maximum tolerated dose (MTD) of PIO in patients with spontaneous ICH and to explore the rate of hematoma resolution and clinical outcome. Methods: Patients with spontaneous ICH within 24 hours of symptom onset were randomly allocated 1:1 to placebo or PIO. Patients received escalating doses of PIO daily for three days, followed by a 30mg maintenance dose for the duration of treatment. Duration of treatment was when 75% of the ICH had resolved as determined by serial MRI or 10 weeks of treatment, whichever occurred first. The primary safety outcome was mortality at Day 14. Secondary measures of safety include any mortality, symptomatic cerebral edema, congestive heart failure, edema, hypoglycemia, anemia, and hepatotoxicity. Secondary measures of efficacy include hematoma resolution and clinical outcome. The MTD was determined using the Continual Reassessment Method. Results: From March 2009 to April 2013, 84 patients (42 PIO, 42 control) were enrolled into 11 dose tiers, with a planned range from 0.1-2.0 mg/kg/d. Table 1 demonstrates preliminary baseline and clinical characteristics of patients by treatment group. Overall, 2/84 patients died within 2 weeks after ICH; however mortality rate never exceeded prespecified criteria. The study will be complete in October 2013 and the treatment team remains blinded to treatment allocation. Secondary outcomes by treatment group and the MTD of PIO will be reported. Conclusions: We have completed the treatment phase of the SHRINC Trial. Long term follow-up is on-going. These results will provide the foundation for an efficacy trial evaluating PIO as a potential treatment for patients with spontaneous ICH.
    Type of Medium: Online Resource
    ISSN: 0039-2499 , 1524-4628
    RVK:
    Language: English
    Publisher: Ovid Technologies (Wolters Kluwer Health)
    Publication Date: 2014
    detail.hit.zdb_id: 1467823-8
    Location Call Number Limitation Availability
    BibTip Others were also interested in ...
Close ⊗
This website uses cookies and the analysis tool Matomo. More information can be found here...