Rapid Assessment of Potential Ischaemic Heart Disease With CTCA
NCT ID: NCT02284191
Last Updated: 2024-08-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
1749 participants
INTERVENTIONAL
2015-03-31
2020-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
SINGLE
Study Groups
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CT Coronary Angiogram
CT Coronary Angiogram plus standard care
CT Coronary Angiogram
Completion of a CT Coronary Angiogram
Standard Care
Standard care only
No interventions assigned to this group
Interventions
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CT Coronary Angiogram
Completion of a CT Coronary Angiogram
Eligibility Criteria
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Inclusion Criteria
* 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
* 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;
* 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
18 Years
ALL
No
Sponsors
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NHS Lothian
OTHER_GOV
University of Edinburgh
OTHER
Responsible Party
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Principal Investigators
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Alasdair J Gray
Role: PRINCIPAL_INVESTIGATOR
NHS Lothian
Locations
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Jersey General Hospital
Saint Helier, , Jersey
Basildon and Thurrock University Hospitals NHS Foundation Trust
Basildon, , United Kingdom
Ulster Hospital
Belfast, , United Kingdom
Queen Elizabeth Hospital
Birmingham, , United Kingdom
The Royal Bournemouth and Christchurch Hospital
Bournemouth, , United Kingdom
Bradford Royal Infirmary
Bradford, , United Kingdom
Russells Hall Hospital
Dudley, , United Kingdom
Ninewells Hospital
Dundee, , United Kingdom
Royal Infirmary Edinburgh
Edinburgh, , United Kingdom
Glasgow Royal Infirmary
Glasgow, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Raigmore Hospital
Inverness, , United Kingdom
Victoria Hospital
Kirkcaldy, , United Kingdom
Leeds General Infirmary
Leeds, , United Kingdom
University Hospital Lewisham
Lewisham, , United Kingdom
Royal London Hospital
London, , United Kingdom
St. Thomas' Hospital
London, , United Kingdom
University Hospital North Tees
London, , United Kingdom
Whipps Cross Hospital
London, , United Kingdom
Luton & Dunstable Hospital
Luton, , United Kingdom
Borders General Hospital
Melrose, , United Kingdom
Milton Keynes University Hospital NHS Foundation Trust
Milton Keynes, , United Kingdom
Royal Victoria Infirmary
Newcastle, , United Kingdom
Derriford Hospital
Plymouth, , United Kingdom
Queen Alexandra Hospital
Portsmouth, , United Kingdom
Royal Berkshire NHS Foundation Trust
Reading, , United Kingdom
East Surrey Hospital
Redhill, , United Kingdom
Rotherham Hospital
Rotherham, , United Kingdom
Sandwell General Hospital
Sandwell, , United Kingdom
Northern General Hospital
Sheffield, , United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, , United Kingdom
University Hospitals of the Midlands
Stoke, , United Kingdom
Torbay Hospital
Torquay, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Worcestershire Royal Hospital
Worcester, , United Kingdom
Wrexham Maelor Hospital
Wrexham, , United Kingdom
University Hospital South Manchester
Wythenshawe, , United Kingdom
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Protocol publication
Final Publication
Lay Summary of Results
Lay Summary of Results
Other Identifiers
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RAPID-CTCA-2014
Identifier Type: -
Identifier Source: org_study_id
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