ANZCTR search results

This 12 week trial aims to investigate the feasibility, acceptability and effectiveness of an innovative physical activity metric [Personal Activity Intelligence (PAI)] for 30 Defence force personnel and/or their immediate family following cardiac rehabilitation. Rather than counting steps, or trying to self-quantify a mix and match of different exercise types and intensities, people will have a simple target (100 Personal Activity Intelligence Score/week) that takes into account the ‘dose’ of exercise in the context of their individual body response recorded through a smartwatch. We hypothesise PAI monitoring will improve physical activity levels and intensity, general psychological well being and adherence. This approach has the potential to improve heart health and prevent long-term comorbidities and hospital re-admissions, thereby reducing healthcare costs and saving lives.

Gout is the result of high levels of uric acid in the blood depositing in the joints. It can also deposit in the kidneys and is associated with kidney disease, cardiovascular disease and death. The treatment for gout is tablets that lower uric acid in the blood stream, but most people with gout aren’t prescribed uric acid lowering therapies, or simply don’t take their medications. People with diabetes have are more at risk of developing gout than people without diabetes, due to high levels of uric acid in the blood. This study aims to identify the extent to which current diabetes medications may lower uric acid; with the hope of avoiding the need to add additional therapies to treat gout in people who already take many medicines. This is likely to increase adherence to gout therapy in people with diabetes, improving outcomes and decreasing the long term complications of gout including joint pain and death form cardiovascular disease.

The aim of this study is to investigate whether use of an imaging technique, indocyanine green angiography (ICGA), during reconstructive breast surgery after mastectomy (removal of all breast tissue) can reduce a major complication. This complication is dead breast skin tissue (necrosis) of the overlying breast skin (mastectomy skin flap). This occurs because there is inadequate blood flow to the skin resulting in breakdown. This can result in further surgery, poor cosmetic results, delay in chemotherapy or radiotherapy, and increased costs to the healthcare system. Who is it for? You may be eligible for this study if you are aged 18 years or older, are scheduled for unilateral (one-sided) or bilateral (both sides) nipple- or skin-sparing mastectomy followed by breast reconstruction. Study details Participants will receive a mastectomy and breast reconstruction using ICGA to assess blood flow to the skin flap and make adjustments such as delay reconstruction surgery or remove dying skin. Participants will return for a follow-up assessment at 7 days, 30 days and 90 days post-surgery involving a clinical assessment of the surgical site, and will be monitored for re-admission to hospital or any other complications for 12 months post-surgery. It is hoped that this study may demonstrate that the use of intraoperative ICGA in breast reconstruction surgery following mastectomy will decrease the incidence of mastectomy skin flap necrosis compared to surgery without use ICGA, which may help to reduce complications and improve cosmetic outcome.

The primary aim of this project is to examine the feasibility and efficacy of the Things You Do Intervention on anxiety, depression, and disability outcomes. The intervention encourages participants to increase how frequently they engage in a list of activities (e.g., treating self with respect, eating a healthy meal). The intervention will e delivered via a PDF lesson with text message reminders, and will be compared to a waitlist group. We anticipate that this intervention will lead to reductions in anxiety, depression, and disability.

Patients with an OPA1 mutation inherit a condition called dominant optic atrophy (DOA) which causes vision loss over time. A medication called idebenone has been shown to decrease the vision loss in patients with a similar condition, called Leber's Hereditary Optic Neuropathy, and thus this trial will investigate whether similar results can be seen in patients with dominant optic atrophy. The study will be a blinded randomised placebo-controlled study. One arm of the study will include participants with DOA who will receive idebenone, and the second arm will include participants with DOA who will receive a placebo. At the end of 12 months, the groups will be investigated to see if there is a between group difference in the rate of visual decline.

CanaCare is a clinical trial incorporating a multi disciplinary team with interventions that utilise structured physical activty under the guidance of an Exercise physiologist, a nutritional educational intervention with a registered Dietitian, and a mindfulness/meditation component. The participants are anyone involved in Cana communities, a non government organaisation that supports members of our community that experience mental health issues, substance use disorders or any other social marginalisation. The primary outcome measurement is a happiness/quality of lfe scale measured at numerous timepoints up to six months. (The Oxford Happiness Questionnaire). Public Hypothesis. The primary aim of the CanaCare program is to utilise a person-centred approach to care planning and delivery, provided in collaboration with an interdisciplinary team with the overall aim of improving the health and wellness for all participants.

Spontaneous coronary artery dissection (SCAD) is a dissection of the coronary artery with formation of an intramural haematoma or ‘false’ lumen. The resultant obstruction to myocardial blood supply leads to acute coronary syndrome (ACS) or sudden death. SCAD has a strong female predominance, with up to 90% of cases women; the majority young and healthy without cardiovascular risk factors. It is this predilection for younger women that has played a part in SCAD being universally under-recognised and under-researched. Whilst we now appreciate that SCAD is not a rare disease, the bigger problem is that we know little about how to prevent or treat it. Clinical SCAD research is urgently needed if we are to uncover more than just the tip of the iceberg in this complex and life-threatening disease. This project will pilot the first ever Australian-New Zealand Spontaneous Coronary Artery Dissection (ANZ-SCAD) Registry. 850 SCAD patients will be recruited from 10-15 hospitals across Australia/NZ with both retrospective (historical cases) and prospective case enrolment. These patients will be recruited from the study sites. Patients will be identified using their medical records and hospital admission with a diagnosis of SCAD. Background medical history (including known pre-disposing genetic conditions), cardiovascular risk factors, medications at baseline and on discharge, presentation, triggers, investigations ( i.e. scans, angiogram, including management (including revascularisation) and in-hospital outcomes. In-hospital pathology results and diabetic profiles will be collected from the medical records. For Prospectively recruited participantst follow up- information such as patients detailed family and medical history, excercise, stress pre- and post- SCAD, quality of life will be collected via questionnaires for a duration of 5 years. No follow up will be performed for retrospectively recruited participants, with all data about treatment and survival taken from medical records.

Mobilisation alarms are a staple in hospitals to prevent falls, but there is uncertain evidence for their effectiveness and they can take up to 11% of all falls prevention management costs. This study aims to produce definitive evidence for their effectiveness. Selected hospital wards will remove or reduce their mobilisation alarms, and the rate of falls and falls-related outcomes will be measured and compared to hospital wards that continue to use the alarms as usual. It is hypothesised that removing or reducing mobilisation alarms will not lead to an increase in falls and falls-related injuries.

Patency of the ductus arteriosus in preterm infants is dictated primarily by Prostaglandin E2 (PGE2) and the non-steroidal anti-inflammatory medications that have long been used to promote ductal closure act by reducing prostaglandin production through cyclooxygenase enzyme inhibition. There is evidence that corticosteroids may also promote ductal closure through at least two mechanisms that impact PGE2 levels. This includes increasing phospholipase A2 inhibitor production with resultant decreased PGE2 synthesis and inhibition of 15-PGHD with resultant increased PGE2 break-down. More importantly, the vast majority of randomised controlled trials evaluating administration of early systemic, inhaled, or intra-tracheal corticosteroids to very preterm infants have found decreased rates of patent ductus arteriosus (PDA) diagnosis, medical treatment of PDA and/or surgical ductal ligation in exposed infants, suggesting a possible effect on early ductus arteriosus closure. What remains unclear is whether the mechanism behind decreased rates of PDA diagnosis and treatment is a direct effect due to corticosteroids promoting early ductus arteriosus closure, or an indirect effect of corticosteroids providing a respiratory benefit that results in clinicians being less inclined to pursue or treat a PDA. The PLUSS Trial is a multicentre, two-arm, parallel, double-blind randomised clinical trial designed to evaluate the effect of early intra-tracheal budesonide (a corticosteroid) mixed with surfactant on survival without BPD in extremely preterm infants born <28 weeks’ gestation (n = 1060). The PLUSS-HEARTS sub-study will utilise the double-blind randomised methodology of PLUSS in select participating sites to measure rates of early ductus arteriosus closure following exposure to intra-tracheal corticosteroids, compared with no exposure. This will hopefully shed light on the true effect of intratracheal corticosteroids on PDA diagnosis or treatment in this high-risk patient population.

An important marker of cardiovascular health is the flexibility of the blood vessels, which is defined as their ability to dilate and constrict. Conversely, blood vessel stiffness, caused by endothelial dysfunction, is associated with cardiovascular disease risk. This is measured using a non-invasive technique called “flow-mediated dilation” (FMD). The risk of developing cardiovascular disease can be indicated by measuring someone’s FMD in the morning, after fasting overnight. This study will help identify dietary and lifestyle factors which may influence endothelial dysfunction (an early marker of cardiovascular disease).