ANZCTR search results

While invasive coronary angiography (ICA) remains one of the most commonly performed procedures in Australia, currently exceeding >100,000 admissions per annum, we have demonstrated >7-fold geographic variation in its use, and only ~27% of these procedures are performed in the context of its core indication of type 1 myocardial infarction (T1MI). Compared with other similar OECD countries, ICA use in Australia is high despite comparable rates of ACS, suggesting that the “appropriateness” of ICA use is sub-optimal in Australian clinical practice. Appropriateness of care depends on three “sufficient” conditions: 1. The patient needs to be at sufficient risk of specific clinical events to warrant the treatment; 2. The treatment must be of sufficient efficacy in reducing relevant events; and 3. The treatment strategy must be of sufficient value to the patient (i.e. absolute benefits versus side-effects, complications and economic costs) Anatomical investigation of the coronary arteries is of proven benefit in directing care and improving outcome in T1MI, but the appropriateness of such investigations in type 2 myocardial infarction (T2MI) and myocardial injury, where there is high risk of cardiac mortality and high competing risk of death from other causes, is unknown. As such, clinical equipoise remains. To date, few studies formally integrating risk assessment into the strategy of coronary investigation and management have been undertaken. A randomised trial of routine early angiography versus conservative management that carefully evaluates baseline patient risks and competing risks, is critical to the development of robust recommendations for these common high morbidity and mortality patients. This study will comprehensively evaluate the clinical impact, and economic value of early anatomic coronary investigation in T2MI and myocardial injury within a pragmatic multi-centre randomised clinical trial.

Healthy eating can assist people with Type 2 Diabetes Mellitus (T2DM) to achieve and maintain glycaemic control, thereby lowering their risk of developing diabetes-related complications. A dietary pattern rich in whole-grains, fruits, vegetables, legumes, and nuts; moderate in alcohol; and low in refined grains, red or processed meats, and sugar-sweetened beverages has been shown to improve glycaemic control in people with T2DM. Consequently, a key feature of international T2DM management recommendations is to eat healthy foods that provide a high-quality diet. People with T2DM have been identified to have low-quality diets, despite recommendations to eat healthy foods. However, it is currently unclear whether people newly diagnosed with T2DM change their diet quality after diagnosis, nor if they maintain positive changes over time. No research has quantitatively explored changes in diet quality after diagnosis, and the factors (demographic, physical and psychosocial) that predict sustained improvements. Therefore, there is no evidence as to whether diet quality remains fixed once an individual is diagnosed with T2DM, or whether there are periods of marked dietary change. There is a clear need to investigate how diet changes over time so targeted strategies can be developed to facilitate improved glycaemic control. Therefore, the aims of the proposed study are to; (i) Describe diet quality changes in the 12 months following T2DM diagnosis. (ii) Identify the demographic, physical and psychosocial predictors of sustained improvements in diet quality defined as an increase in Dietary Approaches to Stop Hypertension (DASH) score of 3 points.

Admissions to intensive care units (ICUs) are increasing due to an aging population. With advances in medical care, patients are surviving an initial stay in critical care; however they are presenting with ongoing health and mental ability limitations following their stay in intensive care. Recent research has focused on the introduction of early rehabilitation within the ICU in an attempt to reduce the long-term complications regarding physical recovery and cognition. To date the exact scope and type of therapeutic care that occupational therapists can provide, as part of the multidisciplinary team, requires further investigation. This research project will investigate how useful and effective certain occupational therapy interventions can be in influencing longer term outcomes relating to physical strength and ability to complete simple daily activities such as self-care and grooming, following an early rehabilitation program within an intensive care unit. It will also interview patients who participated in the early rehabilitation program to understand how they felt about participating and whether there are changes that can be made to make their experience more beneficial. The results of this study will help to redefine how we provide occupational therapy in the intensive care unit and may help to support a clearer and more active role for occupational therapists in future critical care settings.

The purpose of this study is to evaluate the impact of treating concurrent, previously unrecognised obstructive sleep apnoea in patients with treatment resistant epilepsy. The primary outcome is the impact of treatment on seizure control, with secondary outcomes including quality of life and sleep measures, cognitive outcomes, psychiatric outcomes, and biomarkers of neurological injury

This study has been designed to compare relook laparoscopy versus standard follow up for early detection and treatment of patients at high risk for metastases after resection of colorectal cancer. Who is it for? You may be eligible for this study if you are aged between 18 and 80 years, have been diagnosed with primary colorectal cancer for which you have undergone colorectal resection, and are at high risk of the cancer spreading within the abdomen (peritoneal metastases). Study details Participants will be randomly allocated (by chance) to undergo either a relook laparoscopy 9-12 months after initial colorectal cancer surgery in addition to standard follow-up or continue with standard follow-up only. Diagnostic laparoscopy refers to examination of the abdominal cavity through minimally-invasive ("key-hole") surgery. Standard follow up tests include regular blood tests for levels of tumour markers (every three months) and regular CT scans (yearly). Participants will then be followed up over three years to assess disease status (i.e. remission or relapse) and to complete a series of questionnaires to determine quality of life. It is hoped that this research will help determine whether a relook laparoscopy is a valid and effective way of increasing survival rates in patients with high risk colorectal cancer.

Circadian rhythms are vital to normal fetal development but the fetus is dependent on maternal circadian rhythms until near-term. Preterm infants spend the first months of postnatal life in the disruptive setting of constant environmental light and noise, without maternal circadian inputs. In animals, disturbed circadian rhythms are associated with impaired brain development. Cognitive impairment remains the primary morbidity associated with extremely preterm birth and increases health care costs. Therefore, we aim to establish if individual diurnal cycling of environmental light and noise levels improves cognitive outcomes of very preterm infants compared to more constant background lighting and noise. We are undertaking a multicentre, prospective, randomised, open, blinded end-point (PROBE) parallel controlled trial that assesses the effect of non-invasive application of eye masks and ear muffs for 10 hours per night via measurements of neurodevelopmental, social, psychological, physiological, and economic outcomes. We hypothesise that diurnal cycling of light and noise commenced from birth and continued until discharge home will improve the cognitive score (Bayley Scales of Infant Development (BSID) 4th edition), in infants born at < 32 w gestation. Primary outcome will be a mean difference of 4 points in the cognitive score on BSID-4 at 2 years corrected postnatal age. Sample size to achieve 90 % power and alpha 0.05 is 954 infants, assuming a standard deviation of 15 points, a 10 % loss to follow-up and a 30 % adjustment for multiple births. Secondary outcomes will target survival, anthropometry and growth, key neonatal morbidities (BPD/NEC/ROP/Sepsis/IVH), length of hospital stay, survival, Bayley 4 subscores, infant behaviour, sleep, hormonal and clock gene circadian profiles, health service utilisation, core health economic analyses and primary carer mental health and sleep, .

Nutrition delivery to critically ill patients is largely inadequate, resulting in muscle wasting and reduced physical function in the long-term. While factors such as delayed gastric emptying and reduced glucose absorption are relatively well described early in critical illness, there is a paucity of data on the resolution of these derangements. Further, nutrition intake post-extubation and on the post intensive care unit (ICU) ward are also inadequate. Whether factors that are known to influence nutritional intake in ICU are still prevalent post-ICU requires exploration.

Marketing of unhealthy foods through elite sport sponsorship is pervasive in Australia, with massive audience reach. This study aims to examine spectator responses to unhealthy food sponsorship and investigate the utility of alternative, pro-health sport sponsorship options to promote healthier food choices to young adults. The four sponsorship scenarios tested will be: (A) non-food sponsorship (control); (B) unhealthy food sponsorship; (C) healthier food sponsorship; and (D) obesity prevention campaign sponsorship. Participants will be exposed to their assigned sponsorship stimuli; complete a distractor task; then answer a series of questions assessing their brand awareness, attitudes and image perceptions, event-sponsor-fit perceptions, and their preference for food sponsor products. The findings from this study will lay the foundation for developing public health-oriented sport sponsorship policies targeted toward healthy eating and obesity prevention.

We will test the safety and efficacy of N-Acetyl-Cysteine (NAC) as a pharmacotherapy for methamphetamine dependence using a double-blind placebo-controlled randomised controlled trial (RCT). The trial will involve 180 participants receiving either 12 weeks of take-home oral NAC (2,400 mg daily) or equivalent placebo. There are three trial sites (Wollongong, Geelong and Melbourne). This is a Phase 2b trial that is powered to confirm whether NAC has a clinically relevant benefit on methamphetamine use and a range of related clinical outcomes. Primary hypothesis: Daily oral NAC delivered as a take home medication will reduce methamphetamine use measured as (a) days of methamphetamine use, and (b) methamphetamine in weekly saliva tests, during 12 weeks of active treatment relative to placebo. Secondary hypotheses: Daily oral NAC delivered as a take home medication will, relative to placebo: - reduce the severity of methamphetamine dependence, craving for methamphetamine, methamphetamine withdrawal symptoms and psychiatric symptoms (affective symptoms, positive psychotic symptoms and hostility), - have an acceptable adverse event profile, and - not significantly increase the use of other substances (including alcohol, tobacco, cannabis, heroin and cocaine).

This is a phase 1 study in healthy subjects. It is planned to develop the drug for reducing pressure in the brain of patients with a traumatic brain injury (TBI). Increased pressure following TBI can lead to death or can cause permanent disability. There are currently no medications that are approved for improving outcomes after TBI. The drug will also be tested for improving clinical outcome in patients that suffered a concussion. The study drug being evaluated is called EU-C-001 and is being developed by an Australian company called PresSura Neuro. Studies in animals have shown that EU-C-001 may reduce pressure in the brain. Therefore, it is thought that EU-C-001 may improve outcomes in patients with TBI by increasing the amount of oxygen available to brain tissue. In other studies it was shown that the EU-C-001 may also have potential to improve outcomes in patients with concussion. Single oral administrations up to 180 mg EU-C-001 and single intravenous administrations up to 90 mg EU-C-001 have been administered to healthy male subjects. The safety, tolerability and pharmacokinetic information is not yet available in females. Therefore, the present study is planned to investigate the safety, tolerability and the pharmacokinetic characteristics of the medication given intravenously in healthy female subjects and will compare the result from a historical data set obtained from studies in healthy male subjects.