ANZCTR search results

Coronary artery disease (CAD) accounts for 50% of all heart disease cases and 9.2% of all deaths in Australia. Supplementation with omega-3 fatty acids from fish oil shows promise for reducing adverse cardiovascular events. However, current guidelines for omega-3 supplementation vary in their recommended doses, and the optimal dose for better cardiovascular outcomes remains unclear in the literature. In this study, participants will undergo a 12-week period of individualised dose of supplementation with either a placebo or omega-3 fatty acids (fish oil) to determine whether this strategy improves vascular health. Outcome measures will be assessed at baseline, mid-intervention and after completion of the interventions.

Rationale: Coronary angiography is the gold standard test for identifying the presence of significant coronary artery disease, however the procedure is invasive and has risks which drive anxiety, pain and discomfort for patients. Many operators routinely use conscious sedation during invasive procedures including coronary angiography and device insertions, to help mitigate these symptoms. Important risks associated with these pharmacological agents, including respiratory depression, nausea and vomiting, hypotension, paradoxical agitation and post- procedural delirium. In light of these, options for non- pharmacological methods of anxiolysis are increasingly being considered as an adjunct to current practice. Music in the catheter laboratory can be used to create a more relaxed clinical environment, which in turn can help to put the patient at ease. This study aims to investigate whether playing music in the catheter laboratory can reduce patient anxiety and improve the overall patient experience The objective of this study is to determine whether and how the use of music in the catheter laboratory influences the patient experience. The study design is a prospective randomised controlled trial. The study population consists of participants undergoing best practice coronary angiography, percutaneous intervention or device insertion at Gosford Hospital, John Hunter Hospital, Coff’s Harbour Hospital, Port Macquarie Base Hospital, Tamworth Hospital and Dubbo Base Hospital who consent to become enrolled in the trial. The main study endpoints include the primary outcome of self-reported anxiety levels, as measured by the STAIS-5 (Short-Form State-Trait Anxiety Inventory). Secondary outcomes include patient reported pain, adverse outcomes (MACE: Major Adverse Cardiac Events), dosages of sedative medications required, radial artery spasm, haemodynamic data, operator anxiety, complications.

This pilot study aims to leverage the novel imaging capabilities available at the Australian National Total Body PET Facility to identify peripheral nerve amyloidosis in populations with amyloidosis due to either AL or ATTR with the typical length dependent neuropathy, proximal nerve involvement, small and autonomic neuropathy alone and in populations of ATTRwt with neuropathy not explained by alternate causes. We will evaluate for differences in uptake which could differentiate patients with AL versus ATTR amyloidosis and assess for direct nerve infiltration in ATTRwt. We will evaluate Florbetaben uptake in organs and compare this to routine organ screening investigations, and will aim to quantify previously difficult to identify muscle and tenosynovial uptake. Finally, we will explore the feasibility of generating a global amyloid burden score to provide a quantitative measure of whole-body amyloid load, which would have potential to be used in future clinical trials of amyloid depleters.

The primary purpose of this study is to evaluate the safety, pharmacokinetics, and anti-tumour activity of TLN-372 in combination with cobicistat, in patients with advanced KRAS mutant solid tumours. Who is it for? You may be eligible for this study if you are male or female, at least 18 years of age, have measurable locally advanced or metastatic KRAS mutant solid tumours at study entry, an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, and adequate organ function. Study details All eligible participants will receive TLN-372 in combination with cobicistat. Patients will be monitored with clinical visits, blood tests, and radiology images. It is hoped that the result of this study will show if TLN-372 is safe when taken with a helper medication, cobicistat, show if cobicistat interacts with TLN-372 and understand the effects of this interaction on the body, understand how the body absorbs, distributes, breaks down, and gets rid of TLN-372 when given with cobicistat, and show if TLN-372 has the possibility of helping treat patients with advanced solid tumours with a KRAS mutation. This research will hopefully help further the development of TLN-372 to improve the treatment for patients with KRAS mutant cancers.

A phase 1, single centre, Randomised, Double-Blind, Placebo-Controlled, First-in-Human Study of Orally Administered BT-409 to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of BT-409 in Adults with Parkinson’s disease. Study population: Male and female adults with diagnosis of Parkinson’s disease aged 50 to 80 years of age (inclusive) at the time of screening. Study design: This is a double-blind, randomised, placebo-controlled study evaluating the safety, tolerability, and pharmacokinetics (PK) of BT-409. The study will be conducted in 3 parts with 1 part on Adult's with Parkinson's Disease: • Part C: a single cohort with 1 dose level in adults diagnosed with Parkinson's Disease

This study will test whether a supervised high-intensity strength training program is safe, practical, and acceptable for people living with mild-to-moderate Parkinson’s disease. Participants will complete a structured gym-based strength training program over approximately 8 weeks, with testing before and after the program. The study will monitor safety (including any adverse events), recruitment and attendance, and changes in physical function, mobility, balance, strength, brain health and quality of life. Some participants and trainers will also be interviewed about their experience. We hypothesise that high-intensity strength training will be safe and feasible to deliver in this population, and may lead to improvements in strength and physical function.

The project consists of a randomised controlled pilot trial to assess whether identification and treatment of obstructive sleep apnea (OSA) in patients with nocturnal hypertension using a previously-validated, general practice-based OSA care model, is: (1) feasible, acceptable and sustainable to patients and general practice staff; (2) clinically effective in improving patient outcomes, including nocturnal hypertension (primary outcome), OSA symptoms, mood and quality of life; and (3) associated with significant reductions in healthcare costs.

Reducing dementia risk score through an 8-week structured, personalised & comprehensive multidomain lifestyle program. This program includes physical exercise, MIND diet, cognitive engagement, personalised coaching, health monitoring and dementia specific risk education. Primary objective is to reduce dementia risk score as measured by the cogdrisk assessment tool from baseline to immediately following the 8-week program. The study will also assess the impact that the program will have on dementia knowledge, sleep, mood, diet, physical exercise, cognition, cognitive engagement, loneliness, health related quality of life, activities of daily living and personalised goals. Feasibility of a dementia prevention program at St Vincents Hospital will be monitored using the RE-AIM (reach, effectiveness, adoption, implementation and maintenance) framework.

Despite advancements in the management of acute myocardial infarction (AMI) including interventional and pharmacological treatments, the reoccurrence rate of coronary events post an AMI remains substantial. AMIs are caused by coronary artery disease (CAD), where there is an accumulation of lipid rich plaque in the coronary artery wall, which when ruptures causes thrombus formation and reduced coronary blood flow to the underlying myocardium. Sodium-glucose co-transporters 2 inhibitors (SGLT2is) are a glucose lowering medication which have been shown to have cardio-protective effects in type 2 diabetes, heart failure and chronic kidney disease. There is increasing evidence to suggest that SGLT2is may play a role in reducing atherosclerosis progression by decreasing inflammation and stabilise coronary plaque. The DECIPHER trial is a prospective, randomised, open label, blinded endpoint (PROBE) phase 4 clinical trial. It aims to assess the effects of 12 months of treatment with SGLT2i, Dapagliflozin on coronary plaque composition via computed tomography coronary angiogram (CTCA), coronary plaque inflammation via 18F -sodium fluoride (NaF) positron emission tomography (PET)/ magnetic resonance (MR) imaging, and myocardial remodelling via cardiac magnetic resonance (CMR) imaging in patients with an acute myocardial infarction. The DECIPHER trial aims to provide insight into the mechanistic action of SGLT2is in CAD and subsequent AMI.

This 16-week, phase II, randomised, placebo-controlled study aims to evaluate the effects of oraglutide QW — an oral formulation of an injectable medicine commonly used to treat type 2 diabetes, that mimics a naturally occurring hormone in the body (GLP-1) to help regulate blood sugar and support weight management — on body weight in overweight or obese individuals without T2D, and on glycaemic control (fasting and postprandial glucose, HbA1c) in those with T2D. Secondary aims are to assess the pharmacokinetic effects of oraglutide QW, as well as changes in gastric emptying, lipid profile (cholesterol and triglycerides), safety, tolerability, and treatment satisfaction in overweight or obese individuals with or without T2D.