Table 5 Summary of key trial registration details

Primary registry and trial identifying number

ISRCTN19102565

Date of registration in primary registry

03/10/2014

Secondary identifying numbers

NCT02284191

Source(s) of monetary or material support

National Institute for Health Research Health Technology Assessment Programme

Primary sponsor

Co-sponsored by University of Edinburgh and NHS Lothian (ACCORD)

Secondary sponsor(s)

N/A

Contact for public queries

rapid.ctca@ed.ac.uk

Contact for scientific queries

Alasdair.gray@nhslothian.scot.nhs.uk

Public title

Rapid Assessment of Potential Ischaemic Heart Disease with CTCA (the RAPID-CTCA trial)

Scientific title

The role of early CT coronary angiography in the evaluation, intervention and outcome of patients presenting to the emergency department with suspected or confirmed acute coronary syndrome

Countries of recruitment

UK

Health condition(s) or problem(s) studied

Acute coronary syndrome

Intervention(s)

CT coronary angiography

Key inclusion and exclusion criteria

INCLUSION CRITERIA

Patient ≥18 years with symptoms mandating investigation for suspected or confirmed ACS with at least one of the following: 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’ of 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 hold breath; atrial fibrillation (where mean heart rate is anticipated to be greater than 75 beats/min after beta blockade)

3. Patient has had ICA or CTCA within last 2 years revealing 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 be in the patient’s interest, due to limited life expectancy, quality of life or functional status

8. Prisoners

Study type

Open parallel randomised controlled trial

Date of first enrolment

23/03/2015

Target sample size

2500

Recruitment status

Open

Primary outcome(s)

The primary endpoint will be all-cause death or recurrent non-fatal type 1 or type 4b MI at one year and time to first such event. MI will be defined according to the most recent Universal Definition [13] and will be adjudicated by two independent cardiologists blinded to the intervention

Key secondary outcomes

1. Hospital length of stay, coronary care length of stay

2. Proportion of patients receiving ICA during index hospitalisation

3. Proportion of patients receiving coronary revascularisation during index hospitalisation

4. Proportion of patients receiving subsequent unplanned coronary revascularisation after index hospitalisation within 12 months

5. Proportion of patients in CTCA arm receiving ICA despite <50% stenosis on CTCA

6. Proportion of patients assigned to CTCA with normal or mild non-obstructive disease

7. Proportion of patients prescribed ACS therapies during index hospitalisation

8. Proportion of patients discharged on prevention treatment or who have alteration in dosage of prevention treatment during index hospitalisation

9. Representation or rehospitalisation with suspected ACS/recurrent chest pain within 12 months

10. Patient symptoms and quality of life up to 12 months

11. National Health Service (NHS) resource utilisation

12. Patient satisfaction

13. Clinician certainty of presenting diagnosis after CTCA

SAFETY

1. Proportion of patients with allergy/anaphylaxis/acute kidney injury

2. Proportion of patients with alternative diagnoses that relate to presentation on CTCA, e.g. aortic dissection or pulmonary embolus

3. Proportion of patients with incidental but potentially concerning finding on CTCA, e.g. malignancy or pulmonary nodules

4. Total average radiation exposure from CTCA in the intervention arm during index hospitalisation

Cost effectiveness: estimated in terms of the incremental cost per quality-adjusted life year (QALY) gained