None listed
Conditions
Brief summary
A prospective, single-blind, multicentre, randomised clinical trial to evaluate the clinical impact and resource implications of the high-sensitvity troponin assay in the care of patients presenting with suspected ACS. The study will enroll 2000 patients presenting to an emergency department with clinical features in whom the treating physician seeks to measure serum troponin level. The study will be run across 5 metropolitan public hospitals in Adelaide, South Australia. Patients will be randomised to either the 4th generation or 5th generation troponin reporting system. Information will be collected on presenting chest pain characteristics. Clinical outcomes (death, new/re-MI, bleeding, stroke, revascularisation) including quality of life will be sought in-hospital and at 30 days, 6-months and 12-months and cost effectiveness will be measured at 12-months.
Interventions
High sensitivity 5th-generation Analytic-Sensitvity troponin T(hsTNT) is a blood assay used to refine the diagnostic sensivity of chest pain clinical pathways. It has a detection limit of down to 0.002 micrograms per litre with a 99th percentile of the upper reference limit observed at 0.014 micrograms per litre. It is measured at presentation for medical care and at 3 and 6 hours from baseline and is repeated following coronary revascularisation.
Sponsors
Flinders medical centre/Flinders clinical research
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Diagnosis
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Presenting to the emergency department with: - Clinical features in whom the treating physician seeks to measure the serum troponin level. - Willing to give informed consent
Exclusion criteria
- Patients with ST-segment elvation on the presenting ECG - Inability to complete clinical history questionnaire due to language of co-morbidity.
Outcome results
None listed