Figure 1: Clinical Trial Coordinators. From left to right: Mel Downey, Dianne Carey, Helen Branagan, Valda Cross and Azette Rafei (Rowena Braaksma absent)


Figure 2: Azette taking blood from a patient involved in a clinical trial

The Cardiac Imaging group comprises six dedicated experienced Registered Nurses who are actively involved in all aspects of clinical trials as Clinical Trial Coordinators.

To maintain a high level of professionalism, our Clinical Trial Coordinators:

• Have advanced clinical and professional knowledge by obtaining higher University qualifications, such as a Masters Degree and Clinical Trial Management Diploma.  Regular ongoing professional education in-service sessions, journal discussions and attending both national and International conferences are some of the ways the group has continued to advance knowledge and keep abreast of research issues.
• Abide by GCP/ICH guidelines and comply with the University of Queensland and the Queensland Nursing Council Code of Conduct for Registered Nurses.
• Work collaboratively with individual ethics committees, particularly with multi-centre studies.
• Maintain clinical skills and hold competencies and certification in the following areas: Cardio-pulmonary Resuscitation (CPR), phlebotomy, intravenous cannulation, laboratory practices such as collection, centrifuging, storage and documentation of samples.  Preparation and shipping of diagnostic samples nationally and internationally.
• Have co-authored published papers, spoken to the public at community health centers and presented lectures at regional and national conferences.
• Are proficient in all aspects of coordinating clinical trials from the ethical submission, recruitment of patients, randomization, collation and presentation of data, through to site closure.
• Demonstrate excellent skills in communication to attract, recruit, retain and encourage participation of subjects in both current and future research trials.
• Liaise and work with various government departments and personnel from large corporations who are at the forefront of cardiac advancements.
• Have established group policy and procedures within the guidelines of the University of Queensland and Queensland Health policy framework.    

Our Clinical Trial Coordinators take time to develop networks in many hospitals which are a valuable resource in influencing project outcomes.

The strong team atmosphere and effective working relationship within the group and between health centres has been developed over a series of projects and it is this shared understanding and trust that is highly valued and maintained by our staff.   This is evidenced by the Clinical Trial Coordinators collaborative work with Queensland Health in many hospitals which include the Royal Brisbane and Women's, Princess Alexandra, Prince Charles, Gold Coast, Logan District and Queen Elizabeth II Jubilee Hospital. This wide area covers an approximate adult population of 950,000.

Coordinating research activities involves close communication with many health workers from many Departments such as Medicine, Surgery, Anaesthetics, Nursing, Dietetics, Pharmacy, Physiotherapy and Speech Therapy, Human Movements and Cardiac Diagnostics and Health Information Services.
 
Collectively the Clinical Trial Coordinators have many years of experience in Intensive Care, Critical Care Facilitators for post graduate Registered Nurses, Coronary Care, Emergency, Management, Perioperative Services, Obstetrics, Midwifery, Community and Rural Health.

We are currently involved in studies sponsored by major Pharmaceutical companies. The following are some of the Pharmaceutical studies we have recently completed or are currently involved in:  

• Boehringer-Ingleheim “ONTARGET” (ONgoing Telmisartan Alone and in combination with Ramipril Global Endpoint Trial). And parallel trial “TRANSCEND” (Telmisartan Randomized AssessmeNt Study in ACE iNtolerant subjects with cardiovascular Disease trial)
• Roche “CAMERA”(CAvedilol MEtoprolol Respiratory Assessment)
• Pfizer “Gemini AALA” blood pressure/lipid trial
• Acusphere “AI 700-32” cardiac contrast trial
• Pfizer “Illuminate” 5 year hypercholesterolemia trial
• Pfizer “Familial Hypercholesterolemia” trial
• Merck Sharpe & Dohme MK0524A/ER Niacin trial
• Bristol Myers Squibb Imaging, cost effectiveness trial of myocardial contract echocardiography using the contrast Definity.

We also excel in our grant funded clinical trials sponsored by the NHMRC and the National Heart Foundation.

Clinical Centre for Research Excellence (CCRE)

CCRE is currently undertaking a research study on the “Effects of lifestyle modification and active risk factor intervention on myocardial and vascular structure and reactivity in diabetes mellitus”. This randomised intervention study seeks proof of the concept that aggressive risk factor control in Type 2 DM can reduce the macrovascular sequelae (both vascular and cardiac) and anatomic progression of atherosclerosis.  240 subjects were recruited and randomized into the usual care group or active intervention group with a focus on lifestyle modification and compliance. The follow up period is 5 years.  This busy study is based at the Princess Alexandra Hospital with investigators from Departments of Diabetes and Endocrinology, Cardiology and the University of Queensland Department of Medicine & Human Movement Studies. It is anticipated that the final results will be known in 2009.

STRATIFY - STudy of Risk Assessment To reduce cardiac events In patients Following major non cardiac surgerY (STRATIFY)

Aim: Multi-centered trial recruiting over 1000 patients prior to surgery from all major Brisbane metropolitan hospitals. The aims are to assess which patients are at risk based on Eagle's criteria. The patients with one or two risk factors are placed in the intermediate group and those with three or more risk factors in the high risk group. In the Intermediate group patients are randomized to either Dobutamine Stress Echo or Bispoprolol titrated to a resting heart rate of 60bpm approximately 2 weeks prior to surgery.Those in the High risk group all have a Dobutamine Stress Echo and then depending on the positive results are randomized to extended care of Bisoprolol, a Statin, and aspirin or usual care under their physicians. Negative results are followed up as usual care.

Outcomes: The study is looking for postoperative cardiac outcomes which are Death, Peri-operative or Conventional Myocardial Infarction.  We are also capturing other cardiac events such as isolated TNI rises, any arrthymias, and exacerbation of Heart Failure pre and postoperatively, post operative hypotension and tachycardia. We follow up patients at one and six months.

Data: Source notes are archived and the database is kept current. Patients are randomized through an independent source. All outcomes are reviewed by an independent medical reviewer. It is anticipated that the final results will be known in 2008.

Perhexiline Study

The impact of perhexiline on regional and global cardiac function in patients with viable myocardium.

Aims: The aim of the study is to identify whether treatment with perhexiline can be used to improve function of viable myocardium.  Specifically the following hypotheses will be addressed:

• Regional function in segments of viable myocardium can be improved with Perhexiline
• Global LV function can be improved with perhexiline in proportion to the number of viable segments; this corresponds to global function changes at post-RVS follow-up
• Improvement in dysfunctional segments corresponds to changes in free fatty acid (FFA) levels