Results

For full results of the study, please see the publication in the BMJ: https://www.bmj.com/content/374/bmj.n2106.full

Participant Summary of Results:

The RAPID-CTCA trial looked at adults coming into the emergency department (or another acute ward in the hospital) with suspected or confirmed heart problems.  The aim of the study was to compare the normal care a patient receives to normal care plus a CT scan of the heart.  This was to see if the addition of a CT scan early in their treatment when they present to hospital with a suspected heart attack helped the doctors make better diagnoses and reduced the number of patients who went on to have a heart attack or die in the next year.

Thirty-seven hospitals in the UK took part and 1749 patients agreed to join the study. The patients recruited were in a reasonably high risk category for heart problems.

What were the key findings?

•             The trial showed that an early CT scan of the heart’s arteries did not make a difference to the number of patients having a heart attack or dying within one year – it was the same in each group.

•             The patients who had a CT scan were just as likely to come back to the hospital within one year with chest pain as those who did not have the scan.

•             Having the CT scan did not change the patients treatment or stop them having further medical problems within one year – it was the same in each group.

The early CT scan of the heart’s arteries was associated with some important benefits:

•             The doctors taking part reported they were more confident about their diagnosis when they had the results of the CT scan to look at.

•             Fewer people (53.8%) went on to have an invasive test to look at their arteries if they had the CT scan compared to those who did not have the scan (60.3%).

The invasive test is good at showing disease in the arteries but can be risky to patients so it’s good for doctors to only to use it when they have to.   We think fewer people might have had the test because the CT scan is very good at showing clear pictures of the heart’s arteries so the doctor can be confident there is no disease and will not need to do another test.   It is important to note that, this reduction in invasive tests did not seem to make a difference in overall number of patients getting treatment like heart stents or having serious problems such as a heart attack compared to the other group.  This is important as it reassures us the doctors did not miss out on important information by not doing the invasive test and suggests to us that the patients who had a CT scan got a good diagnosis and got the treatment they needed for heart disease.

•             Participant were followed up at 1 month, 6months and 1 year after recruitment using quality of life and satisfaction questionnaires. Satisfaction was higher in the CT scan group than in those that did not have the CT scan.   This is possibly because they got faster treatment of their heart condition and the doctors and nurses treating them were more sure about their diagnosis and perhaps due to them not undergoing a more invasive test.

Some drawbacks of the CT scan:

•             Patients who had the CT scan stayed in hospital slightly longer than the other group (1/5th of a day longer).

•             The total cost to the NHS over one-year were also slightly higher in the CT patients (£7,417.95 compared to £6,856.55)

In conclusion, an early CT scan of the heart’s arteries in these reasonably high risk patients presenting to the Emergency Department with suspected or confirmed heart disease made no difference to patients’ treatment and no difference to whether or not they had heart problems in the year after they joined the trial. The CT scan results where useful to doctors and nurses as it helped improve their confidence in their diagnosis and slightly reduced the number of invasive tests which may not have been needed.  The trial team would not recommend the use of the CT scan in this patient group. Although the patients who received the scan were more satisfied than those who did not, the extra radiation associated with the scan and the fact that it only slightly reduced the number of invasive tests means that the team believe it not to be valuable to recommend the CT scan to this particular patient group.

Trial Summary

This is a synopsis of the RAPID-CTCA trial based upon the current version of the trial Protocol, version 6, 19-07-2018, which may be subject to change.

The trial aims to evaluate 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.

ISRCTN No:

ISRCTN19102565

Clinical Trials.gov ID:

NCT02284191

UK Portfolio Adoption:

The trial is funded by the NIHR Health Technology Assessment Programme. The trial has been adopted onto the NIHR portfolio and therefore is eligible to receive CRN support.

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 (MAUs).

Setting:
~30 EDs, acute medical services, radiology and cardiology departments in tertiary/district general NHS hospitals.

Target population:
Patients with suspected or confirmed ACS

Health technologies being assessed:
Early use of ≥64-slice CTCA as part of routine assessment compared to standard care.

Primary Endpoint:
The primary end-point will be all-cause death or recurrent non-fatal type 1 or type 4b MI at one year and time to first such event.

Participating Centres:

Royal Infirmary of Edinburgh – Professor Alasdair Gray

Sheffield Teaching Hospitals Trust – Professor Steve Goodacre

Derriford Hospital, Plymouth – Professor Carl Roobottom and Surgeon Captain Jason Smith

Torbay Hospital, Torquay – Dr Dirk Felmeden

Victoria Hospital, Kirkcaldy – Dr Andy Kinnon

Royal Berkshire Hospital, Reading – Dr Liza Keating

Russells Hall, Hospital, Dudley – Dr Robert Huggett

Royal Bournemouth & Christchurch Hospitals – Dr Jehangir Din

Borders General Hospital – Dr Anne Scott

Lewisham Hospital – Dr Khaled Alfakih

Jersey General Hospital – Dr Andrew Mitchell

Bradford Teaching Hospital – Dr Sudantha Bulugahapitiya

Sandwell Hospital – Dr Derek Connolly

Milton Keynes Hospital – Dr Atilla Kardos

University Hospital Southampton – Professor Nick Curzen

Guys & St Thomas NHS Foundation Trust – Dr Ronak Rajani

Leeds Teaching Hospitals NHS Trust – Dr Saif-El-Dean Abdel-Rahman

Queen Elizabeth Hospital, Birmingham – Dr Ben Holloway

Royal London Hospital – Dr Ceri Davies

Ninewells Hospital – Dr John Irving

University Hospital of North Tees – Dr Justin Carter

New Cross Hospital, Woverhampton – Dr Elsa McAlindon

Basildon and Thurrock University Hospital – Dr. Jason Dungu

University hospital of South Manchester – Dr. Matthias Schmitt

Ulster Hospital – Dr. Patrick Donnelly

Raigmore Hospital, Inverness – Dr. Jonathon Watt

Queen Elizabeth University Hospital, Glasgow – Dr. Claire McGroarty

Worcestershire Acute Hospitals NHS Trust – Dr Will Roberts

East Surrey Hospital – Dr Ansuman Saha

Rotherham NHS Trust – Dr Rangasamy Muthusamy

Royal Victoria Infirmary, Newcastle – Dr Anna Beattie

Glasgow Royal Infirmary – Dr Adrian Brady and Dr David Lowe

Royal Stoke University Hospital- Dr Hefin Jones

Luton & Dunstable Hospital- Dr Christopher Travill

Whipps Cross Hospital- Professor Tim Harris

Queen Alexandra, Portsmouth- Dr Chris Vorweck

Wrexham Mealor Hospital- Dr Ash Basu

Eligibility Criteria

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 99^th 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;

6. Known pregnancy or currently breast feeding;
7. Inability to consent;
8.  Further investigation for ACS would not in the patient’s interest, due to limited life expectancy, quality of life or functional status;
9. Prisoners

GDPR Privacy Statement

If you have participated in the RAPID CTCA study and would like to read how the study complies with GDPR, please click on this link: RAPID CTCA GDPR Privacy Statement v1 13 06 2018