Rapid Assessment of Potential Ischaemic Heart Disease With CTCA

NCT02284191 | Completed Results DMC

• 1 other identifier: RAPID-CTCA-2014
• Study Type: interventional
• Target: 1,749
• Locations: 2 countries
• Sites: 37

Brief Summary

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.

Conditions

Acute Coronary Syndrome

Keywords

Radiology; Acute Medicine; Emergency Medicine; Cardiology

Outcome Measures

Primary Outcomes (1)

• 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.

  1 year (post randomisation)

Secondary Outcomes (18)

• Coronary Heart Disease Death or Subsequent Non-fatal MI

  1 year (post randomisation)

• Cardiovascular Disease Death or Subsequent Non-fatal MI

  1 year (post randomisation)

• Subsequent Non-fatal MI

  1 year (post randomisation)

• Coronary Heart Disease Death

  1 year (post randomisation)

• Cardiovascular Death

  1 year (post-randomisation)

Study Arms (2)

CT Coronary Angiogram

ACTIVE COMPARATOR

CT Coronary Angiogram plus standard care

Radiation: CT Coronary Angiogram

Standard Care

NO INTERVENTION

Standard care only

Interventions

CT Coronary Angiogram RADIATION

Completion of a CT Coronary Angiogram

CT Coronary Angiogram

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.
• 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;

Sponsors & Collaborators

• University of Edinburgh: lead
• NHS Lothian: collaborator

Study Sites (37)

Jersey General Hospital

Saint Helier, Jersey

Location

Basildon and Thurrock University Hospitals NHS Foundation Trust

Basildon, United Kingdom

Location

Ulster Hospital

Belfast, United Kingdom

Location

Queen Elizabeth Hospital

Birmingham, United Kingdom

Location

The Royal Bournemouth and Christchurch Hospital

Bournemouth, United Kingdom

Location

Bradford Royal Infirmary

Bradford, United Kingdom

Location

Russells Hall Hospital

Dudley, United Kingdom

Location

Ninewells Hospital

Dundee, United Kingdom

Location

Royal Infirmary Edinburgh

Edinburgh, EH16 4SA, United Kingdom

Location

Glasgow Royal Infirmary

Glasgow, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Location

Raigmore Hospital

Inverness, United Kingdom

Location

Victoria Hospital

Kirkcaldy, United Kingdom

Location

Leeds General Infirmary

Leeds, United Kingdom

Location

University Hospital Lewisham

Lewisham, United Kingdom

Location

Royal London Hospital

London, United Kingdom

Location

St. Thomas' Hospital

London, United Kingdom

Location

University Hospital North Tees

London, United Kingdom

Location

Whipps Cross Hospital

London, United Kingdom

Location

Luton & Dunstable Hospital

Luton, United Kingdom

Location

Borders General Hospital

Melrose, United Kingdom

Location

Milton Keynes University Hospital NHS Foundation Trust

Milton Keynes, United Kingdom

Location

Royal Victoria Infirmary

Newcastle, United Kingdom

Location

Derriford Hospital

Plymouth, United Kingdom

Location

Queen Alexandra Hospital

Portsmouth, United Kingdom

Location

Royal Berkshire NHS Foundation Trust

Reading, United Kingdom

Location

East Surrey Hospital

Redhill, United Kingdom

Location

Rotherham Hospital

Rotherham, United Kingdom

Location

Sandwell General Hospital

Sandwell, United Kingdom

Location

Northern General Hospital

Sheffield, United Kingdom

Location

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Location

University Hospitals of the Midlands

Stoke, United Kingdom

Location

Torbay Hospital

Torquay, United Kingdom

Location

New Cross Hospital

Wolverhampton, United Kingdom

Location

Worcestershire Royal Hospital

Worcester, United Kingdom

Location

Wrexham Maelor Hospital

Wrexham, United Kingdom

Location

University Hospital South Manchester

Wythenshawe, United Kingdom

Location

Related Publications (8)

• 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.

  PMID: 22922414 RESULT

• 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.

  PMID: 41504639 DERIVED

• 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.

  PMID: 38857986 DERIVED

• 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.

  PMID: 36357133 DERIVED

• 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.

  PMID: 36339063 DERIVED

• 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.

  PMID: 36062819 DERIVED

• 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.

  PMID: 34588162 DERIVED

• 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.

  PMID: 27923390 DERIVED

Related Links

• Protocol publication
• Final Publication
• Lay Summary of Results
• Lay Summary of Results

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Results Point of Contact

• Title: Prof Alasdair Gray Chief Investigator
• Organization: NHS Lothian

alasdair.gray@ed.ac.uk

0131 242 1284

Study Officials

• Alasdair J Gray

  NHS Lothian

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2014
• First Posted: November 5, 2014
• Study Start: March 1, 2015
• Primary Completion: June 1, 2020
• Study Completion: December 1, 2020
• Last Updated: August 21, 2024
• Results First Posted: August 21, 2024

Record last verified: 2023-09

Locations

JE (1); GB (36)