The RAPID-CTCA trial (Rapid Assessment of Potential Ischaemic Heart Disease with CTCA) - a multicentre parallel-group randomised trial to compare early computerised tomography coronary angiography versus standard care in patients presenting with suspected or confirmed acute coronary syndrome: study protocol for a randomised controlled trial

Emergency department attendances with chest pain requiring assessment for acute coronary syndrome (ACS) are a major global health issue. Standard assessment includes history, examination, electrocardiogram (ECG) and serial troponin testing. Computerised tomography coronary angiography (CTCA) enables...

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Bibliographic Details
Published in:Current controlled trials in cardiovascular medicine 2016-12, Vol.17 (1), p.579-579, Article 579
Main Authors: Gray, Alasdair J, Roobottom, Carl, Smith, Jason E, Goodacre, Steve, Oatey, Katherine, O'Brien, Rachel, Storey, Robert F, Na, Lumine, Lewis, Steff C, Thokala, Praveen, Newby, David E
Format: Article
Language:English
Subjects:
Acute coronary syndrome
Acute Coronary Syndrome - diagnostic imaging
Acute Coronary Syndrome - economics
Acute Coronary Syndrome - mortality
Acute Coronary Syndrome - therapy
Acute coronary syndromes
Angiography
Cardiology
Cardiovascular disease
Care and treatment
Clinical outcomes
Clinical Protocols
Cohort analysis
Computed Tomography Angiography
Coronary Angiography - methods
Coronary Artery Disease - diagnostic imaging
Coronary Artery Disease - economics
Coronary Artery Disease - mortality
Coronary Artery Disease - therapy
Coronary Circulation
Coronary vessels
Coronary Vessels - diagnostic imaging
Coronary Vessels - physiopathology
Cost-Benefit Analysis
Electrocardiography
Emergency medical care
Emergency Medical Services
Health care policy
Heart
Hospital Costs
Hospitals
Humans
Ischemia
Medical imaging
Methods
Multidetector Computed Tomography
Pain
Patient outcomes
Patient satisfaction
Predictive Value of Tests
Prognosis
Proportional Hazards Models
Prospective Studies
Research Design
Risk Assessment
Risk Factors
Study Protocol
Time Factors
United Kingdom
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Summary:Emergency department attendances with chest pain requiring assessment for acute coronary syndrome (ACS) are a major global health issue. Standard assessment includes history, examination, electrocardiogram (ECG) and serial troponin testing. Computerised tomography coronary angiography (CTCA) enables additional anatomical assessment of patients for coronary artery disease (CAD) but has only been studied in very low-risk patients. This trial aims to investigate the effect of early CTCA upon interventions, event rates and health care costs in patients with suspected/confirmed ACS who are at intermediate risk. Participants will be recruited in about 35 tertiary and district general hospitals in the UK. Patients ≥18 years old with symptoms with suspected/confirmed ACS with at least one of the following will be included: (1) ECG abnormalities, e.g. ST-segment depression >0.5 mm; (2) history of ischaemic heart disease; (3) troponin elevation above the 99 centile of the normal reference range or increase in high-sensitivity troponin meeting European Society of Cardiology criteria for 'rule-in' of myocardial infarction (MI). The early use of ≥64-slice CTCA as part of routine assessment will be compared to standard care. The primary endpoint will be 1-year all-cause death or recurrent type 1 or type 4b MI at 1 year, measured as the time to such event. A number of secondary clinical, process and safety endpoints will be collected and analysed. Cost effectiveness will be estimated in terms of the lifetime incremental cost per quality-adjusted life year gained. We plan to recruit 2424 (2500 with ~3% drop-out) evaluable patients (1212 per arm) to have 90% power to detect a 20% versus 15% difference in 1-year death or recurrent type 1 MI or type 4b MI, two-sided p 
ISSN:1745-6215
1745-6215
DOI:10.1186/s13063-016-1717-2