Dataset Information

Therapeutic Management of Dyslipidemia Patients at Very High Cardiovascular Risk (CARDIO TRACK): Protocol for the Observational Registry Study.

ABSTRACT: Dyslipidemia is a major modifiable risk factor for atherosclerotic cardiovascular disease. Current South African guidelines recommend titrating lipid-lowering therapy (LLT) to low-density lipoprotein cholesterol (LDL-C) targets stratified by cardiovascular risk. The LDL-C goal for very high-risk patients is <1.8 mmol/L. In international studies, approximately 30% of patients do not achieve this goal despite receiving maximally tolerated statin doses. There is, however, a paucity of data on LDL-C goal achievement in very high-risk South African patients receiving maximal statin doses.The goal of the research it to assess LDL-C goal achievement in, and clinical characteristics of, very high cardiovascular risk dyslipidemic patients receiving maximal tolerated statin doses with or without ezetimibe.This is an observational, cross-sectional South African registry study that plans to include up to 30 sites and 500 study participants. Adult patients with very high cardiovascular risk status receiving stable, maximally tolerated statin doses (with or without ezetimibe) will be eligible for inclusion.Funding has been awarded and enrollment began on November 15, 2017, and was completed on April 13, 2018, with 507 participants. Database lock was done on June 21, 2018. The statistical analysis has commenced and we expect the final clinical study report to be completed by October 2018.This study will document the adequacy of LLT in those at highest risk and will thus fill an important data gap in South Africa. This data may be useful in assessing the need for novel LLTs like proprotein convertase subtilisin/kexin 9 inhibitors that substantially lower cholesterol levels in addition to optimal statin therapy.RR1-10.2196/9248.

SUBMITTER: Naidoo P

PROVIDER: S-EPMC6045791 | biostudies-literature | 2018 Jun

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Therapeutic Management of Dyslipidemia Patients at Very High Cardiovascular Risk (CARDIO TRACK): Protocol for the Observational Registry Study.

Naidoo Poobalan P Mothilal Rashem R Blom Dirk Jacobus DJ

JMIR research protocols 20180629 6

<h4>Background</h4>Dyslipidemia is a major modifiable risk factor for atherosclerotic cardiovascular disease. Current South African guidelines recommend titrating lipid-lowering therapy (LLT) to low-density lipoprotein cholesterol (LDL-C) targets stratified by cardiovascular risk. The LDL-C goal for very high-risk patients is <1.8 mmol/L. In international studies, approximately 30% of patients do not achieve this goal despite receiving maximally tolerated statin doses. There is, however, a pauci ...[more]

PMID: 29959115

Similar Datasets

Project description:IntroductionStatus epilepticus (SE) is a common life-threatening neurological emergency that can cause long-term impairments. Overall outcomes remain poor. Major efforts are required to clarify the epidemiology of SE and the determinants of outcomes, thereby identifying targets for improved management.Methods and analysisICTAL Registry is a multicentre open cohort of critically ill patients with convulsive, non-convulsive or psychogenic non-epileptic SE. Observational methods are applied to collect uniform data. The goal of the ICTAL Registry is to collect high-quality information on a large number of patients, thereby allowing elucidation of the pathophysiological mechanisms involved in mortality and morbidity. The registry structure is modular, with a large core data set and the opportunity for research teams to create satellite data sets for observational or interventional studies (eg, cohort multiple randomised controlled trials, cross-sectional studies and short-term and long-term longitudinal outcome studies). The availability of core data will hasten patient recruitment to studies, while also decreasing costs. Importantly, the vast amount of data from a large number of patients will allow valid subgroup analyses, which are expected to identify patient populations requiring specific treatment strategies. The results of the studies will have a broad spectrum of application, particularly given the multidisciplinary approach used by the IctalGroup research network.Ethics and disseminationThe ICTAL Registry protocol was approved by the ethics committee of the French Intensive Care Society (#CE_SRLF 19-68 and 19-68a). Patients or their relatives/proxies received written information to the use of the retrospectively collected and pseudonymised data, in compliance with French law. Prospectively included patients receive written consent form as soon as they recover decision-making competency; if they refuse consent, they are excluded from the registry. Data from the registry will be disseminated via conference presentations and peer-reviewed publications.Trial registration numberNCT03457831.

Project description:BackgroundOver recent decades, the prevalence of pediatric obesity has increased markedly in developed and developing countries, and the impact of obesity on health throughout the lifespan has led to urgent calls for action. Family-based weight management interventions that emphasize healthy lifestyle changes can lead to modest improvements in weight status of children with obesity. However, these interventions are generally short in duration, reported in the context of randomized controlled trials and there are few reports of outcomes of these treatment approaches in the clinical setting. Answering these questions is critical for improving the care of children with obesity accessing outpatient health services for weight management. In response, the CANadian Pediatric Weight management Registry (CANPWR) was designed with the following three primary aims: 1. Document changes in anthropometric, lifestyle, behavioural, and obesity-related co-morbidities in children enrolled in Canadian pediatric weight management programs over a three-year period; 2. Characterize the individual-, family-, and program-level determinants of change in anthropometric and obesity-related co-morbidities; 3. Examine the individual-, family-, and program-level determinants of program attrition.Methods/designThis prospective cohort, multi-centre study will include children (2-17 years old; body mass index ?85(th) percentile) enrolled in one of eight Canadian pediatric weight management centres. We will recruit 1,600 study participants over a three-year period. Data collection will occur at presentation and 6-, 12-, 24-, and 36-months follow-up. The primary study outcomes are BMI z-score and change in BMI z-score over time. Secondary outcomes include anthropometric (e.g., height, waist circumference,), cardiometabolic (e.g., blood pressure, lipid profile, glycemia), lifestyle (e.g., dietary intake, physical activity, sedentary activity), and psychosocial (e.g., health-related quality of life) variables. Potential determinants of change and program attrition will include individual-, family-, and program-level variables.DiscussionThis study will enable our interdisciplinary team of clinicians, researchers, and trainees to address foundational issues regarding the management of pediatric obesity in Canada. It will also serve as a harmonized, evidence-based registry and platform for conducting future intervention research, which will ultimately enhance the weight management care provided to children with obesity and their families.

Project description:BackgroundFailure to recognise and respond to patient deterioration on hospital wards is a common cause of healthcare-related harm. If patients are not rescued and suffer a cardiac arrest as a result then only around 15% will survive. Track and Trigger systems have been introduced into the NHS to improve both identification and response to such patients. This study examines the association between the type of Track & Trigger System (TTS) (National Early Warning Score (NEWS) versus non-NEWS) and the mode of TTS (paper TTS versus electronic TTS) and incidence of in-hospital ward-based cardiac arrests (IHCA) attended by a resuscitation team.MethodsTTS type and mode was retrospectively collected at hospital level from 106 NHS acute hospitals in England between 2009 to 2015 via an organisational survey. Poisson regression and logistic regression models, adjusted for case-mix, temporal trends and seasonality were used to determine the association between TTS and hospital-level ward-based IHCA and survival rates.ResultsThe NEWS was introduced in England in 2012 and by 2015, three-fifths of hospitals had adopted it. One fifth of hospitals had instituted an electronic TTS by 2015. Between 2009 and 2015 the incidence of IHCA fell. Introduction or use of NEWS in a hospital was associated with a reduction of 9.4% in the rate of ward-based IHCA compared to non-NEWS systems (incidence rate ratio 0.906, p < 0.001). The use of an electronic TTS was also associated with a reduction of 9.8% in the rate of IHCA compared with paper-based TTS (incidence rate ratio 0.902, p = 0.009). There was no change in hospital survival.ConclusionsThe introduction of standardised TTS and electronic TTS have the potential to reduce ward-based IHCA. This is likely to be via a range of mechanisms from early intervention to institution of treatment limits. The lack of association with survival may reflect the complexity of response to triggering of the afferent arm of the rapid response system.

Dataset Information

Therapeutic Management of Dyslipidemia Patients at Very High Cardiovascular Risk (CARDIO TRACK): Protocol for the Observational Registry Study.

Publications

Therapeutic Management of Dyslipidemia Patients at Very High Cardiovascular Risk (CARDIO TRACK): Protocol for the Observational Registry Study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets