Condition category
Circulatory System
Date applied
03/10/2014
Date assigned
07/10/2014
Last edited
30/03/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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 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

Trial website

https://www.emergeresearch.org/trial/rapid-ctca/

Contact information

Type

Scientific

Primary contact

Prof Alasdair Gray

ORCID ID

Contact details

EMeRGE Office
Department of Emergency Medicine
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
+44 (0)131 242 1340
alasdair.gray@nhslothian.scot.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT02284191

Protocol/serial number

HTA 13/04/108

Study information

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

Acronym

RAPID-CTCA

Study hypothesis

This study aims to investigate the effect of early CTCA for ED patients with suspected or confirmed ACS, compared to current standard practice, upon interventions, event rates and health care costs in a pragmatic clinical trial and economic evaluation up to 1 year after the trial.

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/1304108
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0007/136996/PRO-13-04-108.pdf

Ethics approval

South East Scotland Ethics Committee, 15/12/2014, ref: 14/SS/1096

Study design

Open prospective parallel-group randomised controlled trial of CTCA in patients presenting to the ED, MAU or Cardiology Unit with suspected or confirmed ACS in 30 NHS tertiary and district hospitals

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

Not currently available in web format, please use the contact details below to request a patient information sheet

Condition

Emergency/Acute Medicine, Radiology, Cardiology

Intervention

Consented patients will be randomised on a 1:1 basis to CTCA in addition to standard care or standard care alone. All participants will be asked to complete questionnaires at baseline and 1, 6 and 12 months to record QoL, symptoms, patient satisfaction and health services usage.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Current primary outcome measures as of 19/01/2016:
All-cause death or recurrent non-fatal type 1 or type 4b myocardial infarction at one year and time to first such event. Myocardial infarction will be defined according to the most recent Universal Definition [Thygesen K, 2012] and will be adjudicated by two independent cardiologists blinded to the intervention.

Previous primary outcome measures:
All-cause death or recurrent non-fatal type 1 or type 4b myocardial infarction. Myocardial infarction will be defined according to the most recent Universal Definition and will be adjudicated by two independent cardiologists blinded to the intervention.

Secondary outcome measures

Current secondary outcome measures as of 19/01/2016:
1. Hospital length of stay, coronary care length of stay
2. Proportion of patients receiving invasive coronary angiography 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 invasive coronary angiography 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 and/or discharged on secondary prevention treatment or have alteration in dosage of secondary preventive treatment during index hospitalisation
8. Representation or rehospitalisation with suspected ACS/recurrent chest pain within 12 months
9. Patient symptoms and quality of life up to 12 months
10. NHS resource utilisation
11. Patient satisfaction
12. 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 relates to presentation on CTCA e.g. aortic dissection or pulmonary embolus
3. Proportion of patients with incidental finding but potentially concerning 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 lifetime incremental cost per quality-adjusted life year (QALY) gained.

Previous secondary outcome measures:
1. Hospital length of stay, coronary care length of stay
2. Proportion of patients receiving invasive coronary angiography 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 invasive coronary angiography despite <50% stenosis on CTCA
6. Proportion of patients assigned to CTCA with normal or non-diagnostic imaging
7. Proportion of patients prescribed ACS therapies and/or discharged on secondary prevention treatment during index hospitalisation
8. Representation or rehospitalisation with suspected ACS/recurrent chest pain within 12 months
9. Patient symptoms and quality of life up to 12 months
10. NHS resource utilisation
11. Patient satisfaction

Safety:
1. Proportion of patients with allergy/anaphylaxis/acute kidney injury
2. Proportion of patients with alternative diagnoses e.g. aortic dissection or incidental but potentially concerning e.g. malignancy or pulmonary nodules
3. Total radiation exposure in each arm

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

Overall trial start date

01/06/2014

Overall trial end date

31/12/2018

Reason abandoned

Eligibility

Participant inclusion criteria

Current inclusion criteria as of 19/01/2016:
Patients ≥18 years with symptoms mandating investigation for suspected or confirmed ACS with at least one of:
1. ECG abnormalities e.g. ST segment depression >0.5 mm
2. History of ischaemic heart disease (where the clinician assessing patient confirms history based on patient history or available records)
3. 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).


Previous inclusion criteria:
Patients aged 18 years or older with symptoms mandating investigation for suspected or confirmed ACS with at least one of:
1. ECG abnormalities e.g. ST segment depression >0.5 mm
2. History of ischaemic heart disease
3. Troponin elevation above the 99th centile of the normal reference range
(NB troponin assays will vary from site to site; local laboratory reference standards will be used).

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2,500

Participant exclusion criteria

Current exclusion criteria as of 19/01/2016:
1. Signs, symptoms, or investigations supporting high-risk ACS:
1.1. ST elevation MI
1.2. ACS with signs or symptoms of acute heart failure or circulatory shock
1.3. Crescendo episodes of typical anginal pain
1.4. Marked or dynamic ECG changes e.g. ST depression of >3 mm
1.5. Clinical team have scheduled early invasive coronary angiography on day of trial eligibility assessment
2. Patient inability to undergo CT:
2.1. Severe renal failure (serum creatinine >250 µmol/L or estimated glomerular filtration rate <30 mL/min)
2.2. Contrast allergy
2.3. Beta blocker intolerance (if no alternative heart rate limiting agent available/suitable) or allergy
2.4. Inability to breath hold
2.5. 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 breastfeeding
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

Previous 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
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; inability to hold breath; atrial fibrillation (mean heart rate greater than 75 beats per minute)
3. Invasive coronary angiography or CTCA within last 2 years if the previous investigation revealed CAD, 5 years if previous investigation normal
4. Previous recruitment to the trial
5. Known pregnancy
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

Recruitment start date

01/06/2014

Recruitment end date

01/06/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Royal Infirmary of Edinburgh
Edinburgh
EH16 4SA
United Kingdom

Trial participating centre

About 35 EDs, acute medical services, radiology and cardiology departments in tertiary/district general NHS hospitals
-
United Kingdom

Sponsor information

Organisation

The University of Edinburgh (UK)

Sponsor details

c/o Mrs Marise Bucukoglu
ACCORD
The Queen's Medical Research Institute
47 Little France Crescent
Edinburgh
EH16 4TJ
United Kingdom
+44 (0)131 242 3328
marise.bucukoglu@ed.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme (Ref: 13/04/108)

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

01/07/2019

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

30/03/2016: Ethics approval information added.