Rapid Assessment of Potential Ischaemic heart Disease with Computed Tomography Coronary Angiography (CTCA)

Plain English Summary

Background and study aims
Recent advances in imaging technology have given us a non-invasive technique called computed tomography coronary angiography (CTCA). However, this technology has not been tested with patients presenting with suspected or confirmed acute coronary syndrome (e.g. heart attack) to the Emergency Department (ED) in the UK. CTCA is capable of giving a better treatment of such patients with suspected or confirmed acute coronary syndrome. This study aims to find out the effect of early CTCA for Emergency Department patients with suspected or confirmed ACS, compared to current standard practice. We also would like to see if this would be cost-effective to the practice.

Who can participate?
All patients aged 18 or over with suspected or confirmed ACS.

What does the study involve?
Eligible participants will be approached in the ED, Medical Assessment Unit (MAU) or Cardiology Unit and asked if they are willing to take part. They will be randomly allocated to CTCA in addition to standard care or standard care alone. During their admission and after 1, 6 and 12 months all participants will be asked to complete questionnaires about their symptoms, quality of life, satisfaction with their care and how often they have had to use healthcare services. Participants will be in the study for one year.

What are the possible benefits and risks of participating?
It is possible that the results of the scan will help your doctor decide whether or not there is any narrowing or blockage of the blood vessels around your heart. It may also show additional unknown problems in the heart and chest that may not have been detected otherwise. The scan can also reveal other potential causes for your chest pain. We hope that the research will also benefit many more people by helping us decide the best way to treat patients with your condition in the future. A CT Coronary Angiogram is a routine medical procedure. The scan itself is associated with very few side effects. The most important potential side effect, as with an x-ray or CT scan, is the use of radiation. The amount of radiation used during the scan varies but is around two to three times the amount you would normally receive in a year from background natural sources such as cosmic rays. The average excess risk of developing cancer due to a CT scan is 4 in 10,000 compared to a lifetime risk of 1 in 3. There is a very low risk of developing a reaction to the contrast agent. This usually involves an itchy rash that settles down by itself. Occasionally people require additional medications for this. If you are known to have an allergy to the contrast agent you will not be eligible to take part in the study. There is a possibility that the scan could reveal an incidental health problem that you or your doctor is unaware of. If this were to happen we would discuss this with your doctor and arrange appropriate further tests and treatments as necessary.

Where is the study run from?
This study is being co-ordinated by an experienced research team at the University of Edinburgh in collaboration with NHS Lothian. They work closely with doctors and nurses in local research teams in various hospitals throughout the UK.

When is the study starting and how long is it expected to run for?
January 2015 to June 2020 (updated 15/07/2020, previously: December 2018)

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Alasdair Gray
alasdair.gray@nhslothian.scot.nhs.uk

Study website

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• Jersey
• Northern Ireland
• Scotland
• United Kingdom
• Wales

Study participating centres

Sponsor information

The University of Edinburgh (UK)
University/education

c/o Mrs Marise Bucukoglu
ACCORD
The Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
Scotland
United Kingdom

Phone	+44 (0)131 242 3328
Email	marise.bucukoglu@ed.ac.uk
"ROR"	https://ror.org/01nrxwf90

Funders

Funder type

Government

Results and Publications

Study outputs

Editorial Notes

06/09/2022: Publication reference added.
04/10/2021: The following changes have been made:
1. Publication reference added.
2. The total final enrolment number has been added from the reference.
15/01/2021: Internal review.
15/07/2020: The following changes were made to the trial record:
1. The primary outcome measure was changed.
2. The secondary outcome measures were changed.
3. The plain English summary was updated to reflect earlier changes.
14/01/2019: The following changes were made:
1. The recruitment end date was changed from 31/12/2018 to 30/06/2019.
2. The overall trial end date was changed from 01/06/2020 to 30/06/2020.
3. The target number of participants was changed from 2500 to 1735.
4. The intention to publish date was changed from 30/06/2020 to 30/06/2021.
5. All trial participating centres, apart from Edinburgh Royal Infirmary, have been added.
15/09/2017: Individual patient level data sharing statement has been added. Publication and dissemination plans have been added. The intention to publish date has been updated from 01/07/2019 to 30/06/2020. Overall trial dates have been updated from 01/06/2014-31/12/2018 to 01/01/2015-01/06/2020. Recruitment dates have been updated from 01/06/2014-01/06/2017 to 11/03/2015-31/12/2018.
08/09/2017: Internal review.
08/12/2016: Publication reference added.
30/03/2016: Ethics approval information added.