Rapid Assessment of Potential Ischaemic Heart Disease With CTCA
- Conditions
- Acute Coronary Syndrome
- Interventions
- Radiation: CT Coronary Angiogram
- Registration Number
- NCT02284191
- Lead Sponsor
- University of Edinburgh
- Brief Summary
This study aims to investigate the effect of early CTCA in patients with suspected or confirmed Acute Coronary Syndrome (ACS) presenting to the Emergency Department (ED) or Medical Assessment Unit (MAU), upon interventions, event rates and health care costs in a pragmatic clinical trial and economic evaluation up to 1 year after the trial intervention. The primary objective will be to investigate the effect of the intervention on all-cause death or subsequent type 1 or type 4b MI at one year, measured as time to first such event.
- Detailed Description
DESIGN: Open parallel group randomised controlled trial of early computed tomography coronary angiography (CTCA) in patients presenting with suspected/confirmed acute coronary syndrome (ACS) to Emergency Departments (ED) and Medical Assessment Units.
SETTING: 37 EDs, radiology, cardiology and acute medical services in tertiary/district general National Health Service (NHS) hospitals.
TARGET POPULATION: Inclusion Criteria: Patient ≥18 years with symptoms mandating investigation for suspected or confirmed ACS with at least one of: ECG abnormalities e.g. ST segment depression \>0.5 mm; History of ischaemic heart disease (where the clinician assessing patient confirms history based on patient history or available records); Troponin elevation above the 99th centile of the normal reference range or increase in high sensitivity troponin meeting European Society of Cardiology criteria for 'rule-in' or myocardial infarction (NB troponin assays will vary from site to site; local laboratory reference standards will be used). Exclusion Criteria: 1.Signs, symptoms, or investigations supporting high-risk ACS: ST elevation MI; ACS with signs or symptoms of acute heart failure or circulatory shock; Crescendo episodes of typical anginal pain; Marked or dynamic ECG changes e.g. ST depression of \>3 mm; Clinical team have scheduled early invasive coronary angiography on day of trial eligibility assessment. 2. Patient inability to undergo CT: Severe renal failure (serum creatinine \>250 µmol/L or estimated glomerular filtration rate \<30 mL/min); Contrast allergy; Beta blocker intolerance (if no alternative heart rate limiting agent available/suitable) or allergy; Inability to breath hold; Atrial fibrillation (where mean heart rate is anticipated to be greater than 75 beats per minute after beta blockade). 3. Patient has had invasive coronary angiography or CTCA within last 2 years and the previous investigation revealed obstructive coronary artery disease, or patient had either investigation within the last 5 years and the result was normal. 4.Previous recruitment to the trial; 5.Known pregnancy or currently breast feeding; 6. Inability to consent; 7.Further investigation for ACS would not in the patient's interest, due to limited life expectancy, quality of life or functional status; 8.Prisoners
HEALTH TECHNOLOGIES BEING ASSESSED: Early use of ≥64-slice CTCA as part of routine assessment compared to standard care.
MEASUREMENT OF COSTS/OUTCOMES: Primary end-point will be one-year all-cause death or subsequent type 1 or type 4b MI at one year, measured as time to first such event. Secondary endpoints: Key Secondary Endpoints : 1. Coronary Heart Disease (CHD) death or subsequent non-fatal MI; 2. Cardiovascular Disease (CVD) death or subsequent non-fatal MI; 3. Subsequent non-fatal MI; 4.Coronary Heart Disease death; 5. Cardiovascular death; 6. All-cause death. Other Endpoints; Coronary
Heart Disease (CHD) death or subsequent non-fatal MI (type 1 or 4b);Subsequent Non-fatal MI (type 1 or 4b); Non-cardiovascular death; Invasive coronary angiography; Coronary revascularisation; Percutaneous coronary intervention; Coronary artery bypass graft; Proportion of patients prescribed ACS therapies during index hospitalisation; Proportion of patients discharged on preventative treatment or have alteration in dosage of preventative treatment during index hospitalisation; Length of stay for index hospitalisation; Representation or rehospitalisation with suspected ACS/recurrent chest pain within 12 months after index hospitalisation; Chest pain symptoms up to 12 months; Patient satisfaction at 1 month; Clinician certainty of presenting diagnosis after CTCA; Quality of Life (measured by EQ- 5D-5L up to12 months). Adverse Events and Serious Adverse Events; Proportion of patients with alternative cardiovascular diagnoses identified on CTCA; Proportion of patients with non-cardiovascular diagnosis identified on CTCA; Radiation exposure from CTCA as trial intervention. Cost effectiveness:
Estimated in terms of the lifetime incremental cost per quality-adjusted life year (QALY) gained.
SAMPLE SIZE: 1,749 patients (1,748 available for analysis).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1749
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description CT Coronary Angiogram CT Coronary Angiogram CT Coronary Angiogram plus standard care
- Primary Outcome Measures
Name Time Method All-cause Death or Subsequent Non-fatal Type 1 or Type 4b MI at One Year Measured as Time to First Such Event. 1 year (post randomisation) Number of participants categorised as having primary outcome event - all-cause death or subsequent non-fatal myocardial infarction (type 1 or 4b) at one year (post randomisation), measured as time to first such event. Myocardial infarction 'type' was defined according to the most recent Universal Definition (1). and was adjudicated independently by two cardiologists blinded to the intervention and the categorisation added to the study database.
- Secondary Outcome Measures
Name Time Method Radiation Exposure From CTCA as Trial Intervention 1 year (post randomisation) Median effective radiation dose (mSv) from CTCA received by participants in the CTCA arm of the study. Value derived from dose length product (mGy/cm) using conversion factor of 0.014 mSv/mGy/cm.
Coronary Revascularisation 1 year (post randomisation) Number of participants with Coronary revascularisation by percutaneous coronary intervention or coronary artery bypass graft surgery, one year post randomisation
Subsequent Non-fatal MI 1 year (post randomisation) Number of participants with subsequent non-fatal myocardial infarction, at one year post-randomisation.
Number of Patients Prescribed ACS Therapies During Index Hospitalisation 1 year (post randomisation) Number of participants prescribed acute coronary syndrome therapies during index hospitalisation, 1 year (post randomisation)
Representation or Rehospitalisation With Suspected ACS/ Recurrent Chest Pain After Index Hospitalisation 1 year (post randomisation) Number of participants who represented or were rehospitalised with suspected acute coronary syndrome/recurrent chest pain after discharge from index hospitalisation, up to one year after randomisation
Coronary Heart Disease (CHD) Death or Subsequent Non-fatal MI (Type 1 or 4b) 1 year (post randomisation) Number of participants with Coronary heart disease death or subsequent non-fatal myocardial infarction (type 1 or 4b), one year after randomisation
Coronary Artery Bypass Graft 1 year (post randomisation) Number of participants with coronary artery bypass graft procedures, 1 year post randomisation
Length of Stay for Index Hospitalisation A maximum follow up of one-year post-randomisation. Length of Stay for Index Hospitalisation visit, measured in days each participants was hospitalised prior to their discharge. There is no maximum length an index hospitalisation might be for an individual participant, but follow up of participants is for a maximum one year.
All-cause Death 1 year (post-randomisation) Number of participants with "all-cause" death, one year post-randomisation
Subsequent Non-fatal MI (Type 1 or 4b) 1 year (post-randomisation) Number of participants with subsequent non-fatal myocardial infarction (type 1 or 4b), one year post randomisation
Invasive Coronary Angiography 1 year (post randomisation) Number of participants with Invasive coronary angiography procedures, one year post-randomisation
Percutaneous Coronary Intervention 1 year (post randomisation) Number of participants with percutaneous coronary interventions, 1 year (post randomisation)
Discharged on Preventative Treatment or Alteration in Dosage of Preventative Treatment During Index Hospitalisation 1 year (post randomisation) Number of participants discharged on preventative treatment having not been on preventative treatment prior to index hospitalisation, or alteration of dosage of preventative treatment during index hospitalisation, i.e. change in prevention treatment during index hospitalisation.
Coronary Heart Disease Death or Subsequent Non-fatal MI 1 year (post randomisation) Number of participants with coronary heart disease death or subsequent non-fatal myocardial infarction, one year after randomisation.
Cardiovascular Disease Death or Subsequent Non-fatal MI 1 year (post randomisation) Number of participants categorised as having cardiovascular disease death or subsequent non-fatal myocardial infarction, one year after randomisation
Coronary Heart Disease Death 1 year (post randomisation) Number of participants with Coronary Heart Disease deaths, one year after randomisation
Cardiovascular Death 1 year (post-randomisation) Number of participants with cardiovascular death, one year after randomisation
Non-cardiovascular Death 1 year (post-randomisation) Number of participants with non-cardiovascular deaths, one year post-randomisation
Trial Locations
- Locations (37)
Ninewells Hospital
🇬🇧Dundee, United Kingdom
Basildon and Thurrock University Hospitals NHS Foundation Trust
🇬🇧Basildon, United Kingdom
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Russells Hall Hospital
🇬🇧Dudley, United Kingdom
University Hospital Lewisham
🇬🇧Lewisham, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Rotherham Hospital
🇬🇧Rotherham, United Kingdom
St. Thomas' Hospital
🇬🇧London, United Kingdom
Royal Victoria Infirmary
🇬🇧Newcastle, United Kingdom
Royal Berkshire NHS Foundation Trust
🇬🇧Reading, United Kingdom
University Hospitals of the Midlands
🇬🇧Stoke, United Kingdom
Royal London Hospital
🇬🇧London, United Kingdom
Whipps Cross Hospital
🇬🇧London, United Kingdom
East Surrey Hospital
🇬🇧Redhill, United Kingdom
Jersey General Hospital
🇯🇪St Helier, Jersey
Royal Infirmary Edinburgh
🇬🇧Edinburgh, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
Luton & Dunstable Hospital
🇬🇧Luton, United Kingdom
Borders General Hospital
🇬🇧Melrose, United Kingdom
Milton Keynes University Hospital NHS Foundation Trust
🇬🇧Milton Keynes, United Kingdom
Sandwell General Hospital
🇬🇧Sandwell, United Kingdom
University Hospital Southampton NHS Foundation Trust
🇬🇧Southampton, United Kingdom
Torbay Hospital
🇬🇧Torquay, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, United Kingdom
Worcestershire Royal Hospital
🇬🇧Worcester, United Kingdom
Wrexham Maelor Hospital
🇬🇧Wrexham, United Kingdom
University Hospital South Manchester
🇬🇧Wythenshawe, United Kingdom
The Royal Bournemouth and Christchurch Hospital
🇬🇧Bournemouth, United Kingdom
Ulster Hospital
🇬🇧Belfast, United Kingdom
Glasgow Royal Infirmary
🇬🇧Glasgow, United Kingdom
Queen Elizabeth Hospital
🇬🇧Birmingham, United Kingdom
Bradford Royal Infirmary
🇬🇧Bradford, United Kingdom
Victoria Hospital
🇬🇧Kirkcaldy, United Kingdom
Raigmore Hospital
🇬🇧Inverness, United Kingdom
University Hospital North Tees
🇬🇧London, United Kingdom
Queen Alexandra Hospital
🇬🇧Portsmouth, United Kingdom
Northern General Hospital
🇬🇧Sheffield, United Kingdom