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  • 1
    Online Resource
    Online Resource
    SAGE Publications ; 2020
    In:  International Journal of Stroke Vol. 15, No. 4 ( 2020-06), p. 438-453
    In: International Journal of Stroke, SAGE Publications, Vol. 15, No. 4 ( 2020-06), p. 438-453
    Abstract: After an initial stroke, the risk of recurrent stroke is high. Models that implement best-practice recommendations for risk factor management in stroke survivors to prevent stroke recurrence remain elusive. We examined a model which focuses on vascular risk factor management to prevent stroke recurrence in survivors returning to their primary care physicians. This model is coordinated from the stroke unit, integrates specialist stroke services with primary care physicians, and directly involves patients and carers in risk factor management. It is underpinned by the shared care principle in which there is joint participation of specialists as well as primary care physicians in a planned, integrated delivery of care with ongoing involvement of patients and carers, a structure which encourages implementation of best-practice recommendations as well as transferability and sustainability. We hypothesized that an integrated, multimodal intervention based on a shared-care model which supports joint participation of stroke specialists and primary care physicians would improve the implementation of best-practice recommendations for risk factor management in stroke survivors returning to the community. Methods We undertook a double-blind randomized controlled trial, testing the model in three Australian cities using stroke survivors admitted to stroke units and discharged from hospital to return to their primary care physicians. The model was a shared care, multifaceted integrated program which included bidirectional feedback between general practitioner and specialist unit, education, and engagement of patient and carer in self-management with ongoing input from a multidisciplinary team. The primary endpoint was improvement or abolition of risk factors such as raised blood pressure, diabetes, hyperlipidemia, the modification of adverse life-style factors such as lack of exercise, smoking and alcohol abuse and adherence to preventive medication at one year. Intermediate measurement points were scheduled at three monthly intervals. Analysis was by intention to treat, evaluated by covariance or a linear model adjusting for confounding factors or variance of base-line risk factors. The study was registered as ACTRN = 1261100026498. Results The study population was as follows: intervention ( n = 112), control ( n = 137). At baseline, there was no statistical difference between the groups for any variable. At the 12-month evaluation, there was a significant decrease in systolic blood pressure from baseline in the intervention group of 5.2 mmHg ( p  〈  0.01). This change was not observed in the control group ( p = 0.29). Moreover, at 12 months the mean systolic blood pressure in the intervention group was 129.4 mmHg (SD 14.7), a result which was not obtained in controls. Fasting total cholesterol as well as triglycerides was reduced significantly in the intervention group (both p  〈  0.01) but this was not the case in the control group ( p = 0.11 and p = 0.27, respectively). At 12 months, there was no change in BMI in the intervention group but there was a significant increase in BMI ( p = 0.02) in the control group. At 12 months in the intervention group, the mean distance walked with ease compared to the baseline measurements was increased by a mean distance of 600 m while in the control group the distance walked with ease was reduced compared to that measured at baseline. At 12 months, the Barthel index in the intervention group demonstrated improved function ( p = 0.01), but no change was observed in controls. At 12 months in the intervention group, there was a significant decrease in number of standard alcoholic drinks consumed per week compared to the baseline ( p = 0.04). This was not observed in the control group ( p = 0.34). Conclusion In stroke survivors, the ICARUSS (Integrated Care for the Reduction of Secondary Stroke) model is superior to usual care with respect to best-practice recommendations for traditional risk factors as well as behavioral and functional outcomes.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
    detail.hit.zdb_id: 2211666-7
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  • 2
    In: Angiology, SAGE Publications, Vol. 63, No. 8 ( 2012-11), p. 639-644
    Type of Medium: Online Resource
    ISSN: 0003-3197 , 1940-1574
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2012
    detail.hit.zdb_id: 2065911-8
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  • 3
    In: European Stroke Journal, SAGE Publications, Vol. 1, No. 3 ( 2016-09), p. 146-154
    Abstract: Embolic strokes of undetermined source comprise up to 20% of ischemic strokes. The stroke recurrence rate is substantial with aspirin, widely used for secondary prevention. The New Approach riVaroxaban Inhibition of Factor Xa in a Global trial versus ASA to prevenT Embolism in Embolic Stroke of Undetermined Source international trial will compare the efficacy and safety of rivaroxaban, an oral factor Xa inhibitor, versus aspirin for secondary prevention in patients with recent embolic strokes of undetermined source. Main hypothesis In patients with recent embolic strokes of undetermined source, rivaroxaban 15 mg once daily will reduce the risk of recurrent stroke (both ischemic and hemorrhagic) and systemic embolism (primary efficacy outcome) compared with aspirin 100 mg once daily. Design Double-blind, randomized trial in patients with embolic strokes of undetermined source, defined as nonlacunar cryptogenic ischemic stroke, enrolled between seven days and six months from the qualifying stroke. The planned sample size of 7000 participants will be recruited from approximately 480 sites in 31 countries between 2014 and 2017 and followed for a mean of about two years until at least 450 primary efficacy outcome events have occurred. The primary safety outcome is major bleeding. Two substudies assess (1) the relative effect of treatments on MRI-determined covert brain infarcts and (2) the biological underpinnings of embolic strokes of undetermined source using genomic and biomarker approaches. Summary The New Approach riVaroxaban Inhibition of Factor Xa in a Global trial versus ASA to prevenT Embolism in Embolic Stroke of Undetermined Source trial is evaluating the benefits and risks of rivaroxaban for secondary stroke prevention in embolic strokes of undetermined source patients. Main results are anticipated in 2018.
    Type of Medium: Online Resource
    ISSN: 2396-9873 , 2396-9881
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2016
    detail.hit.zdb_id: 2851287-X
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  • 4
    In: Vascular, SAGE Publications, Vol. 20, No. 1 ( 2012-02), p. 1-7
    Type of Medium: Online Resource
    ISSN: 1708-5381 , 1708-539X
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2012
    detail.hit.zdb_id: 2143006-8
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  • 5
    In: International Journal of Stroke, SAGE Publications, Vol. 11, No. 5 ( 2016-07), p. 526-533
    Abstract: Recent evidence supports that most non-lacunar cryptogenic strokes are embolic. Accordingly, these strokes have been designated as embolic strokes of undetermined source (ESUS). Aims We undertook an international survey to characterize the frequency and clinical features of ESUS patients across global regions. Methods Consecutive patients hospitalized for ischemic stroke were retrospectively surveyed from 19 stroke research centers in 19 different countries to collect patients meeting criteria for ESUS. Results Of 2144 patients with recent ischemic stroke, 351 (16%, 95% CI 15% to 18%) met ESUS criteria, similar across global regions (range 16% to 21%), and an additional 308 (14%) patients had incomplete evaluation required for ESUS diagnosis. The mean age of ESUS patients (62 years; SD = 15) was significantly lower than the 1793 non-ESUS ischemic stroke patients (68 years, p ≤ 0.001). Excluding patients with atrial fibrillation ( n = 590, mean age = 75 years), the mean age of the remaining 1203 non-ESUS ischemic stroke patients was 64 years ( p = 0.02 vs. ESUS patients). Among ESUS patients, hypertension, diabetes, and prior stroke were present in 64%, 25%, and 17%, respectively. Median NIHSS score was 4 (interquartile range 2–8). At discharge, 90% of ESUS patients received antiplatelet therapy and 7% received anticoagulation. Conclusions This cross-sectional global sample of patients with recent ischemic stroke shows that one-sixth met criteria for ESUS, with additional ESUS patients likely among those with incomplete diagnostic investigation. ESUS patients were relatively young with mild strokes. Antiplatelet therapy was the standard antithrombotic therapy for secondary stroke prevention in all global regions.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2016
    detail.hit.zdb_id: 2211666-7
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  • 6
    In: Clinical Trials, SAGE Publications, Vol. 17, No. 5 ( 2020-10), p. 576-580
    Abstract: Central adjudication of outcomes is common for randomised trials and should control for differential misclassification. However, few studies have estimated the cost of the adjudication process. Methods We estimated the cost of adjudicating the primary outcome in nine randomised stroke trials (25,436 participants). The costs included adjudicators’ time, direct payments to adjudicators, and co-ordinating centre costs (e.g. uploading cranial scans and general set-up costs). The number of events corrected after adjudication was our measure of benefit. We calculated cost per corrected event for each trial and in total. Results The primary outcome in all nine trials was either stroke or a composite that included stroke. In total, the adjudication process associated with this primary outcome cost in excess of £100,000 for a third of the trials (3/9). Mean cost per event corrected by adjudication was £2295.10 (SD: £1482.42). Conclusions Central adjudication is a time-consuming and potentially costly process. These costs need to be considered when designing a trial and should be evaluated alongside the potential benefits adjudication brings to determine whether they outweigh this expense.
    Type of Medium: Online Resource
    ISSN: 1740-7745 , 1740-7753
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2020
    detail.hit.zdb_id: 2159773-X
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  • 7
    In: International Journal of Stroke, SAGE Publications, Vol. 6, No. 1 ( 2011-02), p. 3-9
    Abstract: The Clopidogrel for High Atherothrombotic Risk and Ischaemic Stabilisation, Management and Avoidance (CHARISMA) trial reported no statistically significant benefit of adding clopidogrel to acetylsalicylic acid in the long-term management of a broad population of patients with stable vascular disease. However, a subanalysis raised the hypothesis that dual antiplatelet therapy with clopidogrel plus acetylsalicylic acid may be more effective than aspirin in patients with prior ischaemic stroke, myocardial infarction of symptomatic peripheral arterial disease. We aimed to determine whether the possible benefits of clopidogrel plus acetylsalicylic acid in patients with transient ischaemic attack and ischaemic stroke may be ‘front-loaded’, and maximal within the first 30-days of randomisation, without being unduly hazardous. Methods This was a subanalysis of a randomised, double-blind, placebo-controlled trial of clopidogrel vs. placebo, in addition to background therapy with low-dose acetylsalicylic acid (CHARISMA trial), restricted to all patients with transient ischaemic attack or ischaemic stroke. The primary efficacy outcome was stroke, and safety outcome severe bleeding, during the follow-up period. Results Among all transient ischaemic attack and ischaemic stroke patients randomised to placebo ( n=2163), 131 (6·1%) experienced a stroke during follow-up compared with 105 (4·9%) of 2157 patients assigned clopidogrel (hazard ratio: 0·80, 95% confidence intervals: 0·62–1·03). There was no significant difference in severe bleeding (1·7% placebo vs. 1·9% clopidogrel, hazard ratio: 1·11, 95% confidence intervals: 0·71–1·73). Among all patients randomised within 30-days of their qualifying transient ischaemic attack or ischaemic stroke to placebo ( n=667), 46 (6·9%) experienced a stroke compared with 34 (5·1%) of 664 patients assigned clopidogrel (hazard ratio: 0·74, 0·46–1·16). There was no significant difference in severe bleeding (1·6% placebo vs. 1·4% clopidogrel, hazard ratio: 0·83, 95% confidence intervals: 0·34–2·01). Conclusion The data are consistent with, but do not prove the hypothesis that early addition of clopidogrel to acetylsalicylic acid in patients with transient ischaemic attack and ischaemic stroke of arterial origin may be more effective and acceptably safe compared with acetylsalicylic acid alone. Adequately powered clinical trials that are dedicated to exploring this hypothesis are needed.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2011
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  • 8
    In: International Journal of Stroke, SAGE Publications, Vol. 13, No. 1 ( 2018-01), p. 47-56
    Abstract: Previous studies suggested that enlarged perivascular spaces are neuroimaging markers of cerebral small vessel disease. However, it is not clear whether enlarged perivascular spaces are associated with cognitive impairment. We aimed to determine the cross-sectional relationship between enlarged perivascular spaces and small vessel disease, and to investigate the relationship between enlarged perivascular spaces and subsequent cognitive impairment in patients with recent cerebral ischemic event. Methods Anonymized data were accessed from the virtual international stroke trial archive. We rated number of lacunes, white matter hyperintensities, brain atrophy, and enlarged perivascular spaces with validated scales on magnetic resonance brain images after the index stroke. We defined cognitive impairment as a mini mental state examination score of ≤26, recorded at one year post stroke. We examined the associations between enlarged perivascular spaces and clinical and imaging markers of small vessel disease at presentation and clinical evidence of cognitive impairment at one year using linear and logistic regression models. Results We analyzed data on 430 patients with mean (±SD) age 64.7 (±12.7) years, 276 (64%) males. In linear regression analysis, age (β = 0.24; p  〈  0.001), hypertension (β = 0.09; p = 0.025), and deep white matter hyperintensities (β = 0.31; p  〈  0.001) were associated with enlarged perivascular spaces. In logistic regression analysis, basal ganglia enlarged perivascular spaces were independently associated with cognitive impairment at one year after adjusting for clinical confounders (OR = 1.72, 95% CI = 1.22–2.42) and for clinical and imaging confounders (OR = 1.54; 95% CI = 1.03–2.31). Conclusions Our data show that in patients with ischemic cerebral events, enlarged perivascular spaces are cross-sectionally associated with age, hypertension, and white matter hyperintensities and suggest that enlarged perivascular spaces in the basal ganglia are associated with cognitive impairment after one year.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2018
    detail.hit.zdb_id: 2211666-7
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  • 9
    In: International Journal of Stroke, SAGE Publications, Vol. 18, No. 7 ( 2023-08), p. 873-878
    Abstract: Anti-inflammatory therapy using colchicine has reduced recurrent vascular events in patients with coronary heart disease. Design: Colchicine in High-risk Patients with Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3) is a randomized, double-blind, placebo-controlled multicenter trial, in which 8,238 patients with acute minor-to-moderate ischemic stroke (NIHSS ⩽ 5) or high-risk transient ischemic attack (TIA) (ABCD 2 score ⩾4) and a high-sensitivity CRP (hsCRP) level of ⩾2 mg/L will be randomly assigned within 24 h of symptom onset to colchicine (1 mg daily on days 1–3, followed by 0.5 mg daily for a total of 90 days) or matching placebo, on a background of optimal medical therapy. The study will have 90% power to detect a 25% reduction in the primary efficacy outcome of any stroke within 3 months of randomization. Adverse events potentially related to the use of colchicine will also be analyzed. The primary analysis will be by intention to treat. Trial registry name: Colchicine in High-risk Patients with Acute Minor-to-moderate Ischemic Stroke or Transient Ischemic Attack (CHANCE-3); URL: https://clinicaltrials.gov/ct2/show/NCT05439356?cond=CHANCE-3 & draw=2 & rank=1 ; Registration number: NCT05439356.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
    detail.hit.zdb_id: 2211666-7
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  • 10
    In: International Journal of Stroke, SAGE Publications
    Abstract: Improving physical activity levels and diet quality are important for secondary stroke prevention. Aim: To test the feasibility and safety of 6-month, co-designed telehealth-delivered interventions to increase physical activity and improve diet quality. Methods: A 2 × 2 factorial trial (physical activity (PA); diet (DIET); PA + DIET; control) randomized, open-label, blinded endpoint trial. Primary outcomes were feasibility and safety. Secondary outcomes included stroke risk factors (blood pressure, self-report PA (International Physical Activity Questionnaire (IPAQ)) and diet quality (Australian Recommended Food Score (ARFS)), and quality of life. Between-group differences were analyzed using linear-mixed models. Results: Over 23 months, 99 people were screened for participation and 40 (40%) randomized (3 months to 10 years post-stroke, mean age 59 (16) years). Six participants withdrew, and an additional five were lost to follow-up. Fifteen serious adverse events were reported, but none were deemed definitely or probably related to the intervention. Median attendance was 32 (of 36) PA sessions and 9 (of 10) DIET sessions. The proportion of missing primary outcome data (blood pressure) was 3% at 3 months, 11% at 6 months, and 14% at 12 months. Between-group 95% confidence intervals showed promising, clinically relevant differences in support of the interventions across the range of PA, diet quality, and blood pressure outcomes. Conclusion: Our telehealth PA and diet interventions were safe and feasible and may have led to significant behavior change. Trial Registration: ACTRN12620000189921.
    Type of Medium: Online Resource
    ISSN: 1747-4930 , 1747-4949
    Language: English
    Publisher: SAGE Publications
    Publication Date: 2023
    detail.hit.zdb_id: 2211666-7
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