Acute Coronary SyndromeRAPID-CTCANCT02284191

Rapid Assessment of Potential Ischaemic Heart Disease With CTCA

A study testing CT Coronary Angiogram in people with Acute Coronary Syndrome, run by University of Edinburgh at 37 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Coronary Syndrome
What is being tested?: CT Coronary Angiogram
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,749 participants
Where: 37 sitesin 2 countries
Study dates: Mar 2015to Dec 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

Who cannot join

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.

Show all 18Show fewer

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).
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.
Previous recruitment to the trial;
Known pregnancy or currently breast feeding;
Inability to consent;
Further investigation for ACS would not in the patient's interest, due to limited life expectancy, quality of life or functional status;
Prisoners

Trial locations and contacts

37 sites in 2 countries.

Country

City, postcode or hospital

37 sites in 2 countries

United Kingdom36 sites

Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon
Ulster Hospital
Belfast
Queen Elizabeth Hospital
Birmingham
The Royal Bournemouth and Christchurch Hospital
Bournemouth
Bradford Royal Infirmary
Bradford
Russells Hall Hospital
Dudley
Ninewells Hospital
Dundee
Royal Infirmary Edinburgh
Edinburgh, EH16 4SA
Glasgow Royal Infirmary
Glasgow
Queen Elizabeth University Hospital
Glasgow
Raigmore Hospital
Inverness
Victoria Hospital
Kirkcaldy
Leeds General Infirmary
Leeds
University Hospital Lewisham
Lewisham
Royal London Hospital
London
St. Thomas' Hospital
London
University Hospital North Tees
London
Whipps Cross Hospital
London
Luton & Dunstable Hospital
Luton
Borders General Hospital
Melrose
Milton Keynes University Hospital NHS Foundation Trust
Milton Keynes
Royal Victoria Infirmary
Newcastle
Derriford Hospital
Plymouth
Queen Alexandra Hospital
Portsmouth
Royal Berkshire NHS Foundation Trust
Reading
East Surrey Hospital
Redhill
Rotherham Hospital
Rotherham
Sandwell General Hospital
Sandwell
Northern General Hospital
Sheffield
University Hospital Southampton NHS Foundation Trust
Southampton
University Hospitals of the Midlands
Stoke
Torbay Hospital
Torquay
New Cross Hospital
Wolverhampton
Worcestershire Royal Hospital
Worcester
Wrexham Maelor Hospital
Wrexham
University Hospital South Manchester
Wythenshawe

Other trials in United Kingdom

Jersey1 site

Jersey General Hospital
Saint Helier

About this study

Official 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.

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.

Read the 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).

Conditions: Acute Coronary Syndrome
Being tested: CT Coronary Angiogram
Keywords: Radiology, Acute Medicine, Emergency Medicine, Cardiology
Medical subject headings: Acute Coronary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CT Coronary AngiogramRadiation
Completion of a CT Coronary Angiogram

Study groups in NCT02284191
Study group	Role	What they receive
CT Coronary Angiogram	Active comparator	CT Coronary Angiogram plus standard care Receives: Radiation: CT Coronary Angiogram
Standard Care	No intervention	Standard care only

What is being measured

The primary outcome is the main question the study is designed to answer.

All-cause Death or Subsequent Non-fatal Type 1 or Type 4b MI at One Year Measured as Time to First Such Event.
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.
Measured: 1 year (post randomisation)

Secondary outcomes (18)

Coronary Heart Disease Death or Subsequent Non-fatal MI
Number of participants with coronary heart disease death or subsequent non-fatal myocardial infarction, one year after randomisation.
Measured: 1 year (post randomisation)
Cardiovascular Disease Death or Subsequent Non-fatal MI
Number of participants categorised as having cardiovascular disease death or subsequent non-fatal myocardial infarction, one year after randomisation
Measured: 1 year (post randomisation)
Subsequent Non-fatal MI
Number of participants with subsequent non-fatal myocardial infarction, at one year post-randomisation.
Measured: 1 year (post randomisation)
Coronary Heart Disease Death
Number of participants with Coronary Heart Disease deaths, one year after randomisation
Measured: 1 year (post randomisation)
Cardiovascular Death
Number of participants with cardiovascular death, one year after randomisation
Measured: 1 year (post-randomisation)
All-cause Death
Number of participants with "all-cause" death, one year post-randomisation
Measured: 1 year (post-randomisation)
Coronary Heart Disease (CHD) Death or Subsequent Non-fatal MI (Type 1 or 4b)
Number of participants with Coronary heart disease death or subsequent non-fatal myocardial infarction (type 1 or 4b), one year after randomisation
Measured: 1 year (post randomisation)
Subsequent Non-fatal MI (Type 1 or 4b)
Number of participants with subsequent non-fatal myocardial infarction (type 1 or 4b), one year post randomisation
Measured: 1 year (post-randomisation)
Non-cardiovascular Death
Number of participants with non-cardiovascular deaths, one year post-randomisation
Measured: 1 year (post-randomisation)
Invasive Coronary Angiography
Number of participants with Invasive coronary angiography procedures, one year post-randomisation
Measured: 1 year (post randomisation)
Coronary Revascularisation
Number of participants with Coronary revascularisation by percutaneous coronary intervention or coronary artery bypass graft surgery, one year post randomisation
Measured: 1 year (post randomisation)
Percutaneous Coronary Intervention
Number of participants with percutaneous coronary interventions, 1 year (post randomisation)
Measured: 1 year (post randomisation)
Coronary Artery Bypass Graft
Number of participants with coronary artery bypass graft procedures, 1 year post randomisation
Measured: 1 year (post randomisation)
Number of Patients Prescribed ACS Therapies During Index Hospitalisation
Number of participants prescribed acute coronary syndrome therapies during index hospitalisation, 1 year (post randomisation)
Measured: 1 year (post randomisation)
Discharged on Preventative Treatment or Alteration in Dosage of Preventative Treatment During Index Hospitalisation
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.
Measured: 1 year (post randomisation)
Length of Stay for Index Hospitalisation
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.
Measured: A maximum follow up of one-year post-randomisation.
Representation or Rehospitalisation With Suspected ACS/ Recurrent Chest Pain After Index Hospitalisation
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
Measured: 1 year (post randomisation)
Radiation Exposure From CTCA as Trial Intervention
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.
Measured: 1 year (post randomisation)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2015Dec 2020

First posted5 Nov 2014 (estimated)
Study startMar 2015
Primary completionJun 2020
Study completionDec 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (8)Papers the sponsor has linked to this study.
Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
More trials run by University of EdinburghThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 1,749 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02284191
Sponsor's protocol ID: RAPID-CTCA-2014
Acronym: RAPID-CTCA
Status last verified: Sep 2023
First submitted: 6 Oct 2014
Last updated: 21 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. No abstract available.
PubMed 22922414
Lakshmanan S, Wang KL, Meah MN, Tzolos E, Bularga A, Dweck MR, Curzen N, Kardos A, Keating L, Storey RF, Mills NL, Slomka PJ, Dey D, Gray A, Williams MC, Roobottom C, Newby DE. Diagnostic and Prognostic Performance of Pericoronary Adipose Tissue Attenuation in Suspected Acute Coronary Syndrome: Insights from the RAPID-CTCA Trial. Radiol Cardiothorac Imaging. 2026 Feb;8(1):e250074. doi: 10.1148/ryct.250074.
PubMed 41504639
Wang KL, Taggart C, McDermott M, O'Brien R, Oatey K, Keating L, Storey RF, Felmeden D, Curzen N, Kardos A, Roobottom C, Smith J, Goodacre S, Newby DE, Gray AJ; RAPID-CTCA Investigators. Clinical decision aids and computed tomography coronary angiography in patients with suspected acute coronary syndrome. Emerg Med J. 2024 Jul 22;41(8):488-494. doi: 10.1136/emermed-2024-213904.
PubMed 38857986
Meah MN, Tzolos E, Wang KL, Bularga A, Dweck MR, Curzen N, Kardos A, Keating L, Storey RF, Mills NL, Slomka PJ, Dey D, Newby DE, Gray A, Williams MC, Roobottom C. Plaque Burden and 1-Year Outcomes in Acute Chest Pain: Results From the Multicenter RAPID-CTCA Trial. JACC Cardiovasc Imaging. 2022 Nov;15(11):1916-1925. doi: 10.1016/j.jcmg.2022.04.024. Epub 2022 Jun 15.
PubMed 36357133
Meah MN, Bularga A, Tzolos E, Chapman AR, Daghem M, Hung JD, Chiong J, Taggart C, Wereski R, Gray A, Dweck MR, Roobottom C, Curzen N, Kardos A, Felmeden D, Mills NL, Slomka PJ, Newby DE, Dey D, Williams MC. Distinguishing Type 1 from Type 2 Myocardial Infarction by Using CT Coronary Angiography. Radiol Cardiothorac Imaging. 2022 Oct 27;4(5):e220081. doi: 10.1148/ryct.220081. eCollection 2022 Oct.
PubMed 36339063
Gray AJ, Roobottom C, Smith JE, Goodacre S, Oatey K, O'Brien R, Storey RF, Curzen N, Keating L, Kardos A, Felmeden D, Lee RJ, Thokala P, Lewis SC, Newby DE. Early computed tomography coronary angiography in adults presenting with suspected acute coronary syndrome: the RAPID-CTCA RCT. Health Technol Assess. 2022 Aug;26(37):1-114. doi: 10.3310/IRWI5180.
PubMed 36062819
Gray AJ, Roobottom C, Smith JE, Goodacre S, Oatey K, O'Brien R, Storey RF, Curzen N, Keating L, Kardos A, Felmeden D, Lee RJ, Thokala P, Lewis SC, Newby DE; RAPID-CTCA Investigators. Early computed tomography coronary angiography in patients with suspected acute coronary syndrome: randomised controlled trial. BMJ. 2021 Sep 29;374:n2106. doi: 10.1136/bmj.n2106.
PubMed 34588162
Gray AJ, Roobottom C, Smith JE, Goodacre S, Oatey K, O'Brien R, Storey RF, Na L, Lewis SC, Thokala P, Newby DE. The RAPID-CTCA trial (Rapid Assessment of Potential Ischaemic Heart Disease with CTCA) - a multicentre parallel-group randomised trial to compare early computerised tomography coronary angiography versus standard care in patients presenting with suspected or confirmed acute coronary syndrome: study protocol for a randomised controlled trial. Trials. 2016 Dec 7;17(1):579. doi: 10.1186/s13063-016-1717-2.
PubMed 27923390

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official 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.
ClinicalTrials.gov ID: NCT02284191
Acronym / sponsor ID: RAPID-CTCA / RAPID-CTCA-2014
Conditions: Acute Coronary Syndrome
Keywords: Radiology, Acute Medicine, Emergency Medicine, Cardiology
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,749 participants (actual)
Lead sponsor: University of EdinburghUniversity, hospital or other
Collaborators: NHS Lothian
Study start: Mar 2015 (actual)
Primary completion: Jun 2020 (actual)
Study completion: Dec 2020 (actual)
First posted: 5 Nov 2014 (estimated)
Results: Posted 21 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

SETTING: 37 EDs, radiology, cardiology and acute medical services in tertiary/district general National Health Service (NHS) hospitals.

HEALTH TECHNOLOGIES BEING ASSESSED: Early use of ≥64-slice CTCA as part of routine assessment compared to standard care.

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).

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
CT Coronary Angiogram	Active comparator	Radiation: CT Coronary AngiogramCT Coronary Angiogram plus standard care
Standard Care	No intervention	–Standard care only

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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).

Key exclusion criteria (18 listed)

Signs, symptoms, or investigations supporting high-risk ACS:
Patient inability to undergo CT:
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.
Previous recruitment to the trial;
Known pregnancy or currently breast feeding;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
CT Coronary AngiogramCompletion of a CT Coronary Angiogram	Radiation	CT Coronary Angiogram

Primary outcome

All-cause Death or Subsequent Non-fatal Type 1 or Type 4b MI at One Year Measured as Time to First Such Event.
Time frame: 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.

18 secondary outcomes

Coronary Heart Disease Death or Subsequent Non-fatal MI
Time frame: 1 year (post randomisation)
Cardiovascular Disease Death or Subsequent Non-fatal MI
Time frame: 1 year (post randomisation)
Subsequent Non-fatal MI
Time frame: 1 year (post randomisation)
Coronary Heart Disease Death
Time frame: 1 year (post randomisation)
Cardiovascular Death
Time frame: 1 year (post-randomisation)
All-cause Death
Time frame: 1 year (post-randomisation)
Coronary Heart Disease (CHD) Death or Subsequent Non-fatal MI (Type 1 or 4b)
Time frame: 1 year (post randomisation)
Subsequent Non-fatal MI (Type 1 or 4b)
Time frame: 1 year (post-randomisation)
Non-cardiovascular Death
Time frame: 1 year (post-randomisation)
Invasive Coronary Angiography
Time frame: 1 year (post randomisation)
Coronary Revascularisation
Time frame: 1 year (post randomisation)
Percutaneous Coronary Intervention
Time frame: 1 year (post randomisation)
Coronary Artery Bypass Graft
Time frame: 1 year (post randomisation)
Number of Patients Prescribed ACS Therapies During Index Hospitalisation
Time frame: 1 year (post randomisation)
Discharged on Preventative Treatment or Alteration in Dosage of Preventative Treatment During Index Hospitalisation
Time frame: 1 year (post randomisation)
Length of Stay for Index Hospitalisation
Time frame: A maximum follow up of one-year post-randomisation.
Representation or Rehospitalisation With Suspected ACS/ Recurrent Chest Pain After Index Hospitalisation
Time frame: 1 year (post randomisation)
Radiation Exposure From CTCA as Trial Intervention
Time frame: 1 year (post randomisation)

Results and safety

Results posted to the registry on 21 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
CTCA Plus Standard Care	877	875
Standard Care	871	868

Primary outcome: All-cause Death or Subsequent Non-fatal Type 1 or Type 4b MI at One Year Measured as Time to First Such Event.

Time frame: 1 year (post randomisation). Count of participants. Unit: Participants

Measure	CT Coronary Angiogram n = 877	Standard Care n = 871
Value	51	53

Population analysed: All randomised participants

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: Protocol defined adverse events were recorded/reported from consent until 10 days after joining the study. Anticipated events which formed the study outcomes (e.g -death, MI) were recorded for one year post randomisation. No other events were recorded. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
CT Coronary Angiogram	18 of 877 (2.1%)	3 of 877 (0.3%)	19 of 877
Standard Care	10 of 871 (1.1%)	0 of 871 (0%)	17 of 871

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 22922414Thygesen K, Alpert JS, Jaffe AS, Simoons ML, Chaitman BR, White HD; Writing Group on the Joint ESC/ACCF/AHA/WHF Task Force for the Universal Definition of Myocardial Infarction; Thygesen K, Alpert JS, White HD, Jaffe AS, Katus HA, Apple FS, Lindahl B, Morrow DA, Chaitman BA, Clemmensen PM, Johanson P, Hod H, Underwood R, Bax JJ, Bonow RO, Pinto F, Gibbons RJ, Fox KA, Atar D, Newby LK, Galvani M, Hamm CW, Uretsky BF, Steg PG, Wijns W, Bassand JP, Menasche P, Ravkilde J, Ohman EM, Antman EM, Wallentin LC, Armstrong PW, Simoons ML, Januzzi JL, Nieminen MS, Gheorghiade M, Filippatos G, Luepker RV, Fortmann SP, Rosamond WD, Levy D, Wood D, Smith SC, Hu D, Lopez-Sendon JL, Robertson RM, Weaver D, Tendera M, Bove AA, Parkhomenko AN, Vasilieva EJ, Mendis S; ESC Committee for Practice Guidelines (CPG). Third universal definition of myocardial infarction. Eur Heart J. 2012 Oct;33(20):2551-67. doi: 10.1093/eurheartj/ehs184. Epub 2012 Aug 24. No abstract available.
Derived from this study: PubMed 41504639Lakshmanan S, Wang KL, Meah MN, Tzolos E, Bularga A, Dweck MR, Curzen N, Kardos A, Keating L, Storey RF, Mills NL, Slomka PJ, Dey D, Gray A, Williams MC, Roobottom C, Newby DE. Diagnostic and Prognostic Performance of Pericoronary Adipose Tissue Attenuation in Suspected Acute Coronary Syndrome: Insights from the RAPID-CTCA Trial. Radiol Cardiothorac Imaging. 2026 Feb;8(1):e250074. doi: 10.1148/ryct.250074.
Derived from this study: PubMed 38857986Wang KL, Taggart C, McDermott M, O'Brien R, Oatey K, Keating L, Storey RF, Felmeden D, Curzen N, Kardos A, Roobottom C, Smith J, Goodacre S, Newby DE, Gray AJ; RAPID-CTCA Investigators. Clinical decision aids and computed tomography coronary angiography in patients with suspected acute coronary syndrome. Emerg Med J. 2024 Jul 22;41(8):488-494. doi: 10.1136/emermed-2024-213904.
Derived from this study: PubMed 36357133Meah MN, Tzolos E, Wang KL, Bularga A, Dweck MR, Curzen N, Kardos A, Keating L, Storey RF, Mills NL, Slomka PJ, Dey D, Newby DE, Gray A, Williams MC, Roobottom C. Plaque Burden and 1-Year Outcomes in Acute Chest Pain: Results From the Multicenter RAPID-CTCA Trial. JACC Cardiovasc Imaging. 2022 Nov;15(11):1916-1925. doi: 10.1016/j.jcmg.2022.04.024. Epub 2022 Jun 15.
Derived from this study: PubMed 36339063Meah MN, Bularga A, Tzolos E, Chapman AR, Daghem M, Hung JD, Chiong J, Taggart C, Wereski R, Gray A, Dweck MR, Roobottom C, Curzen N, Kardos A, Felmeden D, Mills NL, Slomka PJ, Newby DE, Dey D, Williams MC. Distinguishing Type 1 from Type 2 Myocardial Infarction by Using CT Coronary Angiography. Radiol Cardiothorac Imaging. 2022 Oct 27;4(5):e220081. doi: 10.1148/ryct.220081. eCollection 2022 Oct.
Derived from this study: PubMed 36062819Gray AJ, Roobottom C, Smith JE, Goodacre S, Oatey K, O'Brien R, Storey RF, Curzen N, Keating L, Kardos A, Felmeden D, Lee RJ, Thokala P, Lewis SC, Newby DE. Early computed tomography coronary angiography in adults presenting with suspected acute coronary syndrome: the RAPID-CTCA RCT. Health Technol Assess. 2022 Aug;26(37):1-114. doi: 10.3310/IRWI5180.
Derived from this study: PubMed 34588162Gray AJ, Roobottom C, Smith JE, Goodacre S, Oatey K, O'Brien R, Storey RF, Curzen N, Keating L, Kardos A, Felmeden D, Lee RJ, Thokala P, Lewis SC, Newby DE; RAPID-CTCA Investigators. Early computed tomography coronary angiography in patients with suspected acute coronary syndrome: randomised controlled trial. BMJ. 2021 Sep 29;374:n2106. doi: 10.1136/bmj.n2106.
Derived from this study: PubMed 27923390Gray AJ, Roobottom C, Smith JE, Goodacre S, Oatey K, O'Brien R, Storey RF, Na L, Lewis SC, Thokala P, Newby DE. The RAPID-CTCA trial (Rapid Assessment of Potential Ischaemic Heart Disease with CTCA) - a multicentre parallel-group randomised trial to compare early computerised tomography coronary angiography versus standard care in patients presenting with suspected or confirmed acute coronary syndrome: study protocol for a randomised controlled trial. Trials. 2016 Dec 7;17(1):579. doi: 10.1186/s13063-016-1717-2.
Protocol publicationLink provided by the sponsor.
Final PublicationLink provided by the sponsor.
Lay Summary of ResultsLink provided by the sponsor.
Lay Summary of ResultsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alasdair J Gray principal investigator

NHS Lothian

37 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing CT Coronary Angiogram in people with Acute Coronary Syndrome, run by University of Edinburgh at 37 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United Kingdom, Jersey. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause Death or Subsequent Non-fatal Type 1 or Type 4b MI at One Year Measured as Time to First Such Event. (time frame: 1 year (post randomisation)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02284191, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.