None listed
Conditions
Brief summary
Coronary artery disease affects around 1.4 million Australians, and represents one of the most significant causes of death and disability in Australia and worldwide. Over the last two decades the focus in the treatment of coronary artery disease has primarily been on blood vessels of large calibre. However, it is becoming increasingly apparent that small vessels within the heart muscles, which are the main determinant of blood supply to the heart, may in fact have an equally important, if not more dominant role to play in patients with heart attacks or angina. It has also been suggested that small vessel problems may also be responsible for injury to the heart muscle during a stenting procedure, a potentially serious problem which remains a common issue despite recent technological advancement. Currently the understanding of these small vessels and treatment options are limited. This project aims to investigate the role of these small vessels in heart muscle injury during a stenting procedure and elucidate the possible mechanisms which predispose to or cause dysfunction within these small vessels. I also hope to find a treatment strategy which may benefit patients with small vessel problems and thus improve their overall outcome. If successful, I believe the results will have a wide reaching effect in patients with heart attacks, as well as in an emerging group of patients with angina secondary to small vessel dysfunction, which is resistant to conventional therapies.
Interventions
Ambrisentan, endothelin receptor antagonist, oral tablet, 10mg daily
Patients randomised to the ambrisentan arm will be given 10mg of ambrisentan along with standard medical therapy immediately after randomisation. Further doses of ambrisentan will be administered if the standard dosing interval (24 hours) is exceeded between the preceding dose and planned PCI. The total dose of medications given to the patients will be dictated by the number of days between patients' initial presentation and t
Ambrisentan, endothelin receptor antagonist, oral tablet, 10mg daily Patients randomised to the ambrisentan arm will be given 10mg of ambrisentan along with standard medical therapy immediately after randomisation. Further doses of ambrisentan will be administered if the standard dosing interval (24 hours) is exceeded between the preceding dose and planned PCI. The total dose of medications given to the patients will be dictated by the number of days between patients' initial presentation and their PCI procedure. There is no set maximum of total dose.
Sponsors
Prince of Wales Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) Age > 18 years 2) Typical ischaemic chest pain lasting > 20 minutes 3) Either *Electrocardiographic changes: new ST segment depression of > 0.1mV in >2 contiguous leads; or *New transient T wave inversion of > 0.2mV in > 2 contiguous leads or *Troponin T > 100 ng/L; or a 30% rise in a 6-hour troponin when the initial troponin T is 14 – 100 ng/L.
Exclusion criteria
1) complete occlusion of the culprit artery 2) ST-elevation myocardial infarction 3) prior history of a thrombotic disorder 4) pregnant women or women of child bearing potential who are planning to become pregnant within the next 3 months 5) haemodynamic instability 6) acute heart failure during the index admission 7) significant hepatic impairment (history or cirrhosis or abnormal serum ALT or AST 3-fold greater than the upper limit of normal) 8) Patients with idiopathic pulmonary fibrosis (IPF) with or without secondary pulmonary hypertension. 9) Patients who exhibit or may exhibit hypersensitivity to ambrisentan or to any of the excipients 10) significant renal impairment 11) failure to advance either the guide-wire or the angioplasty balloon beyond the stenosis 12) “proximal type” procedural complication
Outcome results
None listed