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  • 1
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    Small intracerebral hemorrhages have a low spot sign prevalence and are less likely to expand
    SAGE Publications ; 2016
    In:  International Journal of Stroke Vol. 11, No. 2 ( 2016-02), p. 191-197
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 11, No. 2 ( 2016-02), p. 191-197
    Abstract: Hematoma expansion is a major predictor of morbidity and mortality after intracerebral hemorrhage (ICH). Both baseline hematoma volume and the CT-angiogram (CTA) spot sign predict hematoma expansion. Because the CTA spot sign may represent foci of active hemorrhage, we hypothesized that patients with smaller baseline hematoma volumes are less likely to be spot sign positive, and therefore less likely to expand. Aim We sought to validate our prior finding that small hematomas are unlikely to expand, and to determine the relationship between baseline hematoma volume, spot sign status, and risk of hematoma expansion. Methods Data were from the prospective PREDICT ICH study. Patients presenting within 6 h of symptom onset with completed baseline CT, CTA, and follow-up CT were included. Baseline hematoma volume was categorized a priori ( 〈 3 mL, 3–10 mL, 10–20 mL, 〉 20 mL). The primary outcome was significant hematoma expansion (≥6 mL, ≥12.5 mL or ≥33%) and secondary outcomes were early neurological worsening, good clinical outcome (modified Rankin Scale 0–3), and mortality at 90 days. Results Among 315 patients meeting the inclusion criteria, baseline hematoma volume category predicted absolute hematoma expansion ( p  〈  0.001), spot sign prevalence ( p  〈  0.001), early neurologic worsening ( p = 0.002), clinical outcome ( p  〈  0.001), and mortality ( p  〈  0.001). Very small hematomas ( 〈 3 mL) were unlikely to be spot positive (7.7%), unlikely to expand (2.6%), and were associated with a 73% chance of good clinical outcome. Spot sign appeared to be most predictive of expansion in the 3–10 mL baseline hematoma volume category. Conclusion Very small hematomas are unlikely to expand and have a low spot sign prevalence. Hemostatic therapy trials may be best targeted at hemorrhages 〉 3 mL in volume.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493015616635
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2016
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  • 2
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    Location of intracerebral haemorrhage predicts haematoma expansion
    SAGE Publications ; 2017
    In:  European Stroke Journal Vol. 2, No. 3 ( 2017-09), p. 257-263
    Details
    In: European Stroke Journal, SAGE Publications, Vol. 2, No. 3 ( 2017-09), p. 257-263
    Abstract: The role of intracerebral haemorrhage location in haematoma expansion remains unclear. Our objective was to assess the effect of lobar versus non-lobar haemorrhage on haematoma expansion and clinical outcome. Patients and methods We analysed data from the prospective PREDICT study where patients with intracerebral haemorrhage presenting to hospital under 6 h of symptom onset received baseline computed tomography (CT), CT angiogram, 24 h follow-up CT, and 90-day mRS. Intracerebral haemorrhage location was categorised as lobar versus non-lobar, and primary outcomes were significant haematoma expansion ( 〉 6 ml) and poor clinical outcome (mRS  〉  3). Multivariable regression was used to adjust for relevant covariates. The primary analysis population was divided by spot sign status and the effect of haemorrhage location was compared to haematoma expansion in exploratory post hoc analysis. Results Among 302 patients meeting the inclusion criteria, lobar haemorrhage was associated with increased haematoma expansion 〉 6 ml (p = 0.003), poor clinical outcome (p = 0.011) and mortality (p = 0.017). When adjusted for covariates, lobar haemorrhage independently predicted significant haematoma expansion (aOR 2.2 (95% CI: 1.1–4.3), p = 0.021) and poor clinical outcome (aOR 2.6 (95% CI: 1.2–5.6), p = 0.019). Post hoc analysis showed that patients who were spot sign negative had a higher degree of haematoma expansion with baseline lobar haemorrhage (lobar 26% versus deep 11%; p = 0.01). No significant associations were observed in spot-positive patients (lobar 52% versus deep 47%; p = 0.69). Discussion and Conclusion Haematoma expansion is more likely to occur with lobar intracerebral haemorrhage and haemorrhage location is associated with poor clinical outcome. As expansion is a promising therapeutic target, hemorrhage location may be helpful for prognostication and as a selection tool in future ICH clinical trials.
    Type of Medium: Online Resource
    ISSN: 2396-9873 , 2396-9881
    URL: Article
    DOI: 10.1177/2396987317715836
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2017
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  • 3
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    Simple anthropometry-based calculations to monitor body composition in athletes: Scoping review and reference values
    SAGE Publications ; 2022
    In:  Nutrition and Health Vol. 28, No. 1 ( 2022-03), p. 95-109
    Details
    In: Nutrition and Health, SAGE Publications, Vol. 28, No. 1 ( 2022-03), p. 95-109
    Abstract: Kinanthropometry offers to exercise and health professionals a standardized procedure of acquiring surface anatomical measurements that might be used to track changes in body composition. Aim: To describe simple anthropometric indices to monitor body composition changes in amateur and elite athletes, and to provide reference values during the competition phase. Methods: A search of articles indexed in PubMed/MEDLINE, ScienceDirect, Cochrane, and SciELO databases using the string body composition AND (anthropometric OR skinfolds OR circumferences OR girth OR estimation equation) AND “body fat”. Inclusion criteria were: quantitative and/or qualitative research published between 2009 and 2020, written in English or Spanish, reporting simple anthropometric indices that included skinfolds, girths, or basic measures in amateur and elite athletes. Results: A total of 51 studies (Price’s index = 66.4%) met all the inclusion criteria and were included in this scoping review. Contrary to the frequent practice, the use of a regression equation might not be accurate to evaluate body composition. To avoid this, anthropometrists should base their analysis on the absolute values of the sum of skinfolds (∑S) and related variables, such as skinfold-corrected girths and lean mass index. While not definitive, because further research is required, the practical recommendations and updated reference values in competition phase provided by this review would contribute to the accurate identification of body composition changes. Conclusions: ∑S and lean mass index have been shown to be valid for monitoring changes in fat mass and fat-free mass, respectively. More research is needed to derive the lean mass index-specific coefficient for each sports population.
    Type of Medium: Online Resource
    ISSN: 0260-1060 , 2047-945X
    URL: Article
    DOI: 10.1177/02601060211002941
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2022
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  • 4
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    Ultrasound-augmented thrombolysis improves outcome in hyperglycaemic stroke
    SAGE Publications ; 2005
    In:  Journal of Cerebral Blood Flow & Metabolism Vol. 25, No. 1_suppl ( 2005-08), p. S114-S114
    Details
    In: Journal of Cerebral Blood Flow & Metabolism, SAGE Publications, Vol. 25, No. 1_suppl ( 2005-08), p. S114-S114
    Type of Medium: Online Resource
    ISSN: 0271-678X , 1559-7016
    URL: Article
    DOI: 10.1038/sj.jcbfm.9591524.0114
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2005
    detail.hit.zdb_id: 2039456-1
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  • 5
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    Endovascular equipoise shift in a phase III randomized clinical trial of sonothrombolysis for acute ischemic stroke
    SAGE Publications ; 2019
    In:  Therapeutic Advances in Neurological Disorders Vol. 12 ( 2019-01), p. 175628641986065-
    Details
    In: Therapeutic Advances in Neurological Disorders, SAGE Publications, Vol. 12 ( 2019-01), p. 175628641986065-
    Abstract: Results of our recently published phase III randomized clinical trial of ultrasound-enhanced thrombolysis (sonothrombolysis) using an operator-independent, high frequency ultrasound device revealed heterogeneity of patient recruitment among centers. Methods: We performed a post hoc analysis after excluding subjects that were recruited at centers reporting a decline in the balance of randomization between sonothrombolysis and concurrent endovascular trials. Results: From a total of 676 participants randomized in the CLOTBUST-ER trial we identified 52 patients from 7 centers with perceived equipoise shift in favor of endovascular treatment. Post hoc sensitivity analysis in the intention-to-treat population adjusted for age, National Institutes of Health Scale score at baseline, time from stroke onset to tPA bolus and baseline serum glucose showed a significant (p  〈  0.01) interaction of perceived endovascular equipoise shift on the association between sonothrombolysis and 3 month functional outcome [adjusted common odds ratio (cOR) in centers with perceived endovascular equipoise shift: 0.22, 95% CI 0.06–0.75; p = 0.02; adjusted cOR for centers without endovascular equipoise shift: 1.20, 95% CI 0.89–1.62; p = 0.24)]. After excluding centers with perceived endovascular equipoise shift, patients randomized to sonothrombolysis had higher odds of 3 month functional independence (mRS scores 0–2) compared with patients treated with tPA only (adjusted OR: 1.53; 95% CI 1.01–2.31; p = 0.04). Conclusion: Our experience in CLOTBUST-ER indicates that increasing implementation of endovascular therapies across major academic stroke centers raises significant challenges for clinical trials aiming to test noninterventional or adjuvant reperfusion strategies.
    Type of Medium: Online Resource
    ISSN: 1756-2864 , 1756-2864
    URL: Article
    DOI: 10.1177/1756286419860652
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2019
    detail.hit.zdb_id: 2442245-9
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  • 6
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    Hemorrhagic Transformation: A Foe that Could Be a Friend?
    SAGE Publications ; 2006
    In:  International Journal of Stroke Vol. 1, No. 4 ( 2006-11), p. 226-227
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 1, No. 4 ( 2006-11), p. 226-227
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/j.1747-4949.2006.00063.x
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2006
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  • 7
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    Factor seven activating protease (FSAP) predicts response to intravenous thrombolysis in acute ischemic stroke
    SAGE Publications ; 2016
    In:  International Journal of Stroke Vol. 11, No. 6 ( 2016-08), p. 646-655
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 11, No. 6 ( 2016-08), p. 646-655
    Abstract: Prediction of recanalization after intravenous thrombolysis could be important to direct secondary reperfusion techniques. Factor seven activating protease (FSAP) has been described to have a relevant pathophysiological role in stroke. Aim The aim is to determine whether plasma FSAP levels are associated with recanalization after tissue plasminogen activator in acute stroke. Methods FSAP antigen, activity, and FSAP-inhibitor complexes were measured in 120 acute stroke patients admitted to Hospital Vall d’Hebron with arterial occlusions, before intravenous thrombolysis. Recanalization was assessed by transcranial Doppler 2 h after thrombolysis. Predictors of recanalization were determined by logistic regression analysis and the additional predictive value of FSAP over them was determined by integrated discrimination improvement index. Results Complete recanalization was achieved in 31 patients. FSAP antigen levels were lower in patients achieving recanalization (8.2 (6.3–11.7) µg/mL vs. 9.8 (7.6–12.8) µg/mL; p = 0.046). After adjustment by age, sex, and National Institutes of Health Stroke Scale, Oxfordshire Community Stroke Project (odds ratio = 0.33 (0.13–0.82), p = 0.017) and FSAP antigen (odds ratio = 3.22 (1.22–8.47), p = 0.018) were independently associated with recanalization, and the addition of FSAP improved the model discrimination (integrated discrimination improvement = 5.5% (1.4–9.7), p = 0.009). Conclusions Our study showed that lower FSAP antigen plasma levels were associated with a higher chance of arterial recanalization after tissue plasminogen activator treatment, suggesting an involvement of FSAP in tissue plasminogen activator-induced clot lysis. FSAP antigen determination might be useful in predicting tissue plasminogen activator response in stroke patients.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493016641949
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2016
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  • 8
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    Estimated treatment effect of ticagrelor versus aspirin by investigator-assessed events compared with judgement by an independent event adjudication committee in the SOCRATES trial
    SAGE Publications ; 2019
    In:  International Journal of Stroke Vol. 14, No. 9 ( 2019-12), p. 908-914
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 14, No. 9 ( 2019-12), p. 908-914
    Abstract: Adjudication of endpoints is a standard procedure in cardiovascular clinical trials. However, several studies indicate that the benefit of adjudication in estimating treatment effect may be limited. Aims This post hoc analysis of SOCRATES (NCT01994720) compared the treatment effects and investigated the agreement of clinical event assessment by site investigators and independent adjudicators. Methods SOCRATES compared ticagrelor and aspirin in 13,199 patients with acute minor stroke or high-risk transient ischemic attack. The primary endpoint was stroke, myocardial infarction, or death. Stroke was the major component of the primary endpoint and a secondary endpoint. The endpoints were adjudicated by a blinded independent committee. We compared the treatment effect on the primary endpoint and stroke alone based on the investigators' and adjudicators' assessments, and investigated the agreement rate on the stroke endpoint and major hemorrhages. Results The hazard ratios (95% confidence interval) for ticagrelor versus aspirin therapy for the primary endpoint were 0.89 (0.78–1.01) when calculated on adjudicator-assessed events and 0.88 (0.78–1.00) for investigator-assessed events. The hazard ratios (95% confidence intervals) for stroke were 0.86 (0.75–0.99) based on the adjudicators' diagnoses and 0.85 (0.75–0.97) based on the investigators' diagnoses. The overall agreement between adjudicator- and investigator-diagnosed stroke was 91%, and for major hemorrhages was 88%. Conclusions In SOCRATES, there was no clinically meaningful difference in the estimated treatment effect, on either the primary endpoint or stroke, by using investigator- or adjudicator-assessed events. Double-blind treatment outcome studies with stroke endpoints may not benefit from adjudication. Trial Registration ClinicalTrials.gov Identifier: NCT01994720.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1177/1747493019851282
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2019
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  • 9
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    Design of a Prospective Multi-National CLOTBUST Collaboration on Reperfusion Therapies for Stroke
    SAGE Publications ; 2008
    In:  International Journal of Stroke Vol. 3, No. 1 ( 2008-02), p. 66-72
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 3, No. 1 ( 2008-02), p. 66-72
    Abstract: The benefit of intravenous (i.v.) tissue plasminogen activator (tPA) in acute ischemic stroke (IS) is attributable to lysis of thrombus and restoration of perfusion to ischemic but not yet infarcted brain. Aims Our multicentre collaborative group prospectively implemented a protocol for transcranial Doppler assessment of intracranial recanalization with tPA treatment based on the CLOTBUST clinical trial (CLOTBUST-PRO). We aim to determine whether early recanalization (within 1 h from tPA bolus) is independently associated with better 3-month outcome in patients with intracranial arterial occlusions and correlates to a shorter time interval elapsed from symptom onset to tPA bolus. Subjects and methods Consecutive patients with acute IS due to intracranial arterial occlusions will be treated with standard i.v.-tPA and continuously monitored with 2 MHz Transcranial Doppler for arterial recanalization. Early recanalization will be determined with the previously validated Thrombolysis in Brain Ischemia flow-grading system within 60 min after tPA bolus. Power calculations are based on the assumption of α = 0·05 (two-sided test) and probabilities of functional independence at 3 months of 0·50 and 0·35 in patients with early complete recanalization and persisting occlusion, respectively. Detection of a 15% difference with a power of 0·824 requires an estimated sample of 480 patients of whom 25% are expected to achieve early recanalization while 75% will have persisting occlusion at 1 h after tPA bolus. We also plan to test prespecified secondary hypotheses within the projected study sample. Conclusions CLOTBUST-PRO is designed to determine if the timing (within 1 h from tPA bolus) of tPA-induced arterial recanalization is an independent determinant of 3-month functional recovery. We also seek to demonstrate that the sooner the tPA is given to stroke patients, the earlier the recanalization occurs and the greater is the likelihood of functional independence at 3 months. Introduction Intravenous (i.v.) tissue plasminogen activator (tPA) remains the only approved therapy for acute ischemic stroke (IS) with faster time to treatment being associated with better outcomes at 3 months ( 1 ). Although the benefit of tPA is attributable to lysis of thrombus and restoration of perfusion to ischemic but not yet infarcted brain ( 2 ), recanalization was not documented in pivotal tPA trials. This hypothesis is supported by both animal and smaller human studies showing that the duration of impaired perfusion is associated with final infarct volume and that early recanalization correlates with smaller infarct size ( 3 – 5 ).
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/j.1747-4949.2008.00167.x
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2008
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  • 10
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    Combined Lysis of Thrombus with Ultrasound and Systemic Tissue Plasminogen Activator for Emergent Revascularization in Acute Ischemic Stroke (Clotbust-ER): Design and Methodology of a Multinational Phase 3 Trial
    SAGE Publications ; 2015
    In:  International Journal of Stroke Vol. 10, No. 7 ( 2015-10), p. 1141-1148
    Details
    In: International Journal of Stroke, SAGE Publications, Vol. 10, No. 7 ( 2015-10), p. 1141-1148
    Abstract: We designed a Phase 3 clinical trial to determine the safety and efficacy of adding transcranial ultrasound using an operator-independent headframe to recombinant tissue-plasminogen-activator for the treatment of acute ischemic stroke. Methods Combined lysis of thrombus with ultrasound and systemic tissue-plasminogen-activator for emergent revascularization in acute ischemic stroke is a randomized, double-blind, placebo-controlled clinical trial that will enroll subjects with the following main inclusion criteria: less than 4·5 hours from symptom onset (three-hours in US and Canada), age 18–80 years, baseline National Institutes of Health Stroke Scale score ≥ 10, and premorbid modified-Rankin-score of 0–1, eligibility for full dose recombinant tissue-plasminogen-activator. Subjects will receive two-hours of 2-MHz pulsed wave transcranial ultrasound (target group) or sham ultrasound (control group). The projected sample size is approximately 824 subjects. Results The primary endpoint, based on intention-to-treat criteria of patients enrolled within three-hours of symptom onset is the comparison between target and control groups of modified-Rankin-score scores at day 90 poststroke assessed using the proportional odds method. The study will have two planned interim analyses after approximately one-third and two-thirds of subjects have reached the 90-day modified-Rankin-score evaluation. Safety outcomes are symptomatic intracranial hemorrhage within 24 h and an overall analysis of adverse events. Conclusions Since intravenous recombinant tissue-plasminogen-activator remains the only medical therapy to reverse ischemic stroke applicable in the emergency department, our trial will determine if the additional use of transcranial ultrasound improves functional outcomes in patients with severe acute ischemic stroke (NCT#01098981).
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    URL: Article
    DOI: 10.1111/ijs.12536
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2015
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