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  • 1
    Publication Date: 2015-04-04
    Description: Objectives Remote ischaemic conditioning (RIC) promotes cardioprotection in patients undergoing primary percutaneous coronary intervention (pPCI) for ST-elevation myocardial infarction (STEMI). The effect of RIC may be modified by cardiovascular risk factors and their medications. We examined whether cardiovascular risk factors, lipid and glucose levels, and medication use influenced the efficacy of RIC in patients with STEMI treated with pPCI. Design Post hoc subgroup analysis of a single-centre randomised controlled trial. Participants A total of 139 patients with STEMI, randomised during ambulance transport to hospital for pPCI with (n=71) or without (n=68) RIC, met the trial criteria and achieved data for a myocardial salvage index (MSI). Interventions RIC was administered through intermittent arm ischaemia with four cycles of 5 min inflation and 5 min deflation of a blood pressure cuff. Primary outcome measures MSI, estimated by single-photon emission CT. We evaluated the efficacy of RIC on the MSI in patient subgroups of cardiovascular risk factors, lipid and glucose levels, and medication use. Results We found no significant difference in the efficacy of RIC in subgroups of cardiovascular risk factors, lipid and glucose levels, and medication use. However, point estimates indicated a reduced effect of RIC among smokers (median difference in MSI between RIC and control groups: –0.02 (95% CI –0.32 to 0.28) in smokers vs 0.25 (95% CI 0.08 to 0.42) in non-smokers, p value for interaction=0.13) and an increased effect of RIC in statin users (median difference in MSI between RIC and control groups: 0.34 (95% CI 0.03 to 0.65) in statin users vs 0.09 (95% CI –0.11 to 0.29) in non-statin users, p value for interaction=0.19). Conclusions RIC as an adjunct to pPCI seems to improve MSI in our trial population of patients with STEMI regardless of most cardiovascular risk factors and their medications. Our post hoc finding on a limited sample size calls for further investigation in large-scale multicentre trials. Trial registration number NCT00435266.
    Keywords: Open access, Cardiovascular medicine
    Electronic ISSN: 2044-6055
    Topics: Medicine
    Published by BMJ Publishing
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  • 2
    Publication Date: 2014-05-04
    Description: Objective To examine sex-specific trends in 4-year mortality among young patients with first acute myocardial infarction (AMI), 1987–2006. Design Prospective cohort study. Setting Sweden. Participants We identified 37 276 cases (19.4% women; age, 25–54 years) from the Swedish Inpatient Register, 1987–2006, who had survived 28 days after an AMI. Outcome measures 4-year mortality from all causes and standard mortality ratio (SMR). Results From the first to last 5-year period, the absolute excess risk decreased from 1.38 to 0.50 and 1.53 to 0.59 per 100 person-years among men aged 25–44 and 45–54 years, respectively. Corresponding figures for women were a decrease from 2.26 to 1.17 and from 1.93 to 1.45 per 100 person-years, respectively. Trends for women were non-linear, decreasing to the same extent as those for men until the third period, then increasing. For the last 5-year period, the standardised mortality ratio for young survivors of AMI compared with the general population was 4.34 (95% CI 3.04 to 5.87) and 2.43 (95% CI 2.12 to 2.76) for men aged 25–44 and 45–54 years, respectively, and 13.53 (95% CI 8.36 to 19.93) and 6.42 (95% CI 5.24 to 7.73) for women, respectively. Deaths not associated with cardiovascular causes increased from 21.5% to 44.6% in men and 41.5% to 65.9% in women. Conclusions Young male survivors of AMI have low absolute long-term mortality rates, but these rates remain twofold to fourfold that of the general population. After favourable development until 2001, women now have higher absolute mortality than men and a 6-fold to 14-fold risk of death compared with women in the general population.
    Keywords: Open access, Cardiovascular medicine
    Electronic ISSN: 2044-6055
    Topics: Medicine
    Published by BMJ Publishing
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  • 3
    Publication Date: 2016-03-27
    Description: Introduction Cognitive–behavioural therapy (CBT) is effective for treating anxiety disorders and is offered in most mental health services around the world. However, a relatively large number of patients with anxiety disorders do not benefit from CBT, experience relapses or drop out. Reliable predictors of treatment effects are lacking. The aim of this study is to investigate the predictive value of emotion regulation and attentional control for CBT outcome in a routine setting. Methods and analysis In this prospective and practice-based study, 112 patients with anxiety disorders referred for manual-based group CBT at two psychiatric outpatient clinics will be recruited. Emotion regulation, severity of anxiety and attentional control will be assessed with self-report measures and with an experimental computer-based attentional control task at baseline, post-treatment and at a 6-month follow-up. Emotion regulation will be measured with Difficulties in Emotion Regulation Questionnaire, severity of anxiety will be assessed with Beck Anxiety Inventory and attentional control will be measured with the self-report questionnaire, Attention Control Scale, and with an experimental computer-based attentional control task based on theory of visual attention. Data will be analysed using multilevel mixed-effects modelling. Ethics and dissemination The study is approved by the Danish National Ethical Board, the Department of Psychology Ethical Board, University of Copenhagen and by the Danish Data Protection Agency. Study findings will be disseminated through peer-reviewed journal publications and conference presentations. The Danish Committee System on Health Research Ethics has been notified about the project. Trial registration number NCT02638363.
    Keywords: Open access, Evidence based practice, Mental health
    Electronic ISSN: 2044-6055
    Topics: Medicine
    Published by BMJ Publishing
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  • 4
    Publication Date: 2018-02-09
    Description: Objective Compare arthroscopic partial meniscectomy to a true sham intervention. Methods Sham-controlled superiority trial performed in three county hospitals in Denmark comparing arthroscopic partial meniscectomy to skin incisions only in patients aged 35–55 years with persistent knee pain and an MRI-confirmed medial meniscus lesion. A computer-generated table of random numbers generated two comparison groups. Participants and outcome assessors were blinded to group allocation. Exclusions were locking knees, high-energy trauma or severe osteoarthritis. Outcomes were collected at baseline, 3 and 24 months. We hypothesised no difference between groups. The primary outcome was the between-group difference in change from baseline to 2 years in the mean score across all five normalised Knee injury and Osteoarthritis Outcome Score (KOOS) subscales (KOOS 5 ). Results Forty-four patients (of the estimated 72) underwent randomisation; 22 in each group. Sixteen participants (36%) were non-blinded and eight participants (36%) from the sham group crossed over to the surgery group prior to the 2-year follow-up. At 2 years, both groups reported clinically relevant improvements (surgery 21.8, skin incisions only 13.6), the mean difference between groups was 8.2 in favour of surgery, which is slightly less than the cut-off of 10 prespecified to represent a clinically relevant difference; judged by the 95% CI (–3.4 to 19.8), a possibility of clinically relevant difference could not be excluded. In total, nine participants experienced 11 adverse events; six in the surgery group and three in the skin-incisions-only group. Conclusion We found greater improvement from arthroscopic partial meniscectomy compared with skin incisions only at 2 years, with the statistical uncertainty of the between-group difference including what could be considered clinically relevant. Because of the study being underpowered, nearly half in the sham group being non-blinded and one-third crossing over to surgery, the results cannot be generalised to the greater patient population. Trial registration number NCT01264991 .
    Keywords: Open access, Surgery
    Electronic ISSN: 2044-6055
    Topics: Medicine
    Published by BMJ Publishing
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