June 21, 2010
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June 23, 2010
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April 10, 2017
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November 2010
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May 2015 (Final data collection date for primary outcome measure)
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Proportion of patients diagnosed with angina pectoris secondary to coronary heart disease [ Time Frame: 6 weeks ]
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Same as current
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- Symptoms [ Time Frame: Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months ]
(i) Chest pain. (ii) Quality of life.
- Diagnosis [ Time Frame: Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months ]
(i) Diagnosis and severity of coronary heart disease (ii) Accuracy of computed tomography coronary angiography
- Investigations [ Time Frame: Baseline, 6 weeks, 6 months ]
(i) Exercise electrocardiographic stress test (ii) Nuclear medicine imaging - myocardial perfusion imaging (iii) Stress echocardiography (iv) Invasive coronary angiography (v) Non-coronary investigations
- Treatment [ Time Frame: Baseline, after computed tomography scan (where appropriate), 6 weeks, 6 months ]
(i) Secondary prevention (ii) Pharmacological anti-anginal therapy (iii) Coronary revascularisation
- Long-term outcome [ Time Frame: 10 years ]
(i) Cardiovascular death or non-fatal Myocardial Infarction (MI) (ii) Cardiovascular death (iii) Non-fatal MI (iv) Cardiovascular death, non-fatal MI or non-fatal stroke (v) Non-fatal stroke (vi) All-cause death (vii) Coronary revascularisation; percutaneous coronary intervention or coronary artery bypass graft surgery (viii) Hospitalisation for chest pain including acute coronary syndromes and non-coronary chest pain (ix) Hospitalisation for cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral arterial disease
|
- Symptoms [ Time Frame: Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months ]
(i) Chest pain. (ii) Quality of life.
- Diagnosis [ Time Frame: Baseline, after computed tomography scan (where appropriate), 6 weeks and 6 months ]
(i) Diagnosis and severity of coronary heart disease (ii) Accuracy of computed tomography coronary angiography
- Investigations [ Time Frame: Baseline, 6 weeks, 6 months ]
(i) Exercise electrocardiographic stress test (ii) Nuclear medicine imaging - myocardial perfusion imaging (iii) Stress echocardiography (iv) Invasive coronary angiography (v) Non-coronary investigations
- Treatment [ Time Frame: Baseline, after computed tomography scan (where appropriate), 6 weeks, 6 months ]
(i) Secondary prevention (ii) Pharmacological anti-anginal therapy (iii) Coronary revascularisation
- Long-term outcome [ Time Frame: 10 years ]
(i) Cardiovascular death or non-fatal MI (ii) Cardiovascular death (iii) Non-fatal MI (iv) Cardiovascular death, non-fatal MI or non-fatal stroke (v) Non-fatal stroke (vi) All-cause death (vii) Coronary revascularisation; percutaneous coronary intervention or coronary artery bypass graft surgery (viii) Hospitalisation for chest pain including acute coronary syndromes and non-coronary chest pain (ix) Hospitalisation for cardiovascular disease including coronary artery disease, cerebrovascular disease and peripheral arterial disease
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Not Provided
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Not Provided
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Scottish COmputed Tomography of the HEART Trial
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Role of Multidetector Computed Tomography in the Diagnosis and Management of Patients Attending a Rapid Access Chest Pain Clinic
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The primary objective of the study is to see if coronary artery calcium score and computed tomography coronary angiogram alters the proportion of patients diagnosed with angina due to coronary heart disease.
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Rapid access chest pain clinics have facilitated the early diagnosis and treatment of patients with coronary heart disease and angina. Despite this important service provision, coronary heart disease continues to be under-diagnosed and many patients are left untreated and at risk. Recent advances in imaging technology have now led to the widespread use of non-invasive computed tomography both to measure coronary artery calcium scores and undertake coronary angiography. However, this technology has not been robustly evaluated in any systematic approach. Using state-of-the-art multidetector computed tomography scanners, we propose to undertake a major multicentre randomized controlled trial to assess the added value of computed tomography imaging in over 4000 patients attending rapid access chest pain clinics across Scotland. This will define the most appropriate use of this emerging technology in the setting of diagnosing and treating patients with coronary heart disease and angina pectoris. This study will also lay the foundation for future studies to look at the potential prognostic value of this technology.
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Interventional
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Not Applicable
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Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Diagnostic
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- Angina Pectoris
- Coronary Heart Disease
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Procedure: Computer Tomography Angiography
Computed Tomography Angiography
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- Newby DE, Williams MC, Flapan AD, Forbes JF, Hargreaves AD, Leslie SJ, Lewis SC, McKillop G, McLean S, Reid JH, Sprat JC, Uren NG, van Beek EJ, Boon NA, Clark L, Craig P, Flather MD, McCormack C, Roditi G, Timmis AD, Krishan A, Donaldson G, Fotheringham M, Hall FJ, Neary P, Cram L, Perkins S, Taylor F, Eteiba H, Rae AP, Robb K, Barrie D, Bissett K, Dawson A, Dundas S, Fogarty Y, Ramkumar PG, Houston GJ, Letham D, O'Neill L, Pringle SD, Ritchie V, Sudarshan T, Weir-McCall J, Cormack A, Findlay IN, Hood S, Murphy C, Peat E, Allen B, Baird A, Bertram D, Brian D, Cowan A, Cruden NL, Dweck MR, Flint L, Fyfe S, Keanie C, MacGillivray TJ, Maclachlan DS, MacLeod M, Mirsadraee S, Morrison A, Mills NL, Minns FC, Phillips A, Queripel LJ, Weir NW, Bett F, Divers F, Fairley K, Jacob AJ, Keegan E, White T, Gemmill J, Henry M, McGowan J, Dinnel L, Francis CM, Sandeman D, Yerramasu A, Berry C, Boylan H, Brown A, Duffy K, Frood A, Johnstone J, Lanaghan K, MacDuff R, MacLeod M, McGlynn D, McMillan N, Murdoch L, Noble C, Paterson V, Steedman T, Tzemos N. Role of multidetector computed tomography in the diagnosis and management of patients attending the rapid access chest pain clinic, The Scottish computed tomography of the heart (SCOT-HEART) trial: study protocol for randomized controlled trial. Trials. 2012 Oct 4;13:184. doi: 10.1186/1745-6215-13-184.
- Singh T, Bing R, Dweck MR, van Beek EJR, Mills NL, Williams MC, Villines TC, Newby DE, Adamson PD. Exercise Electrocardiography and Computed Tomography Coronary Angiography for Patients With Suspected Stable Angina Pectoris: A Post Hoc Analysis of the Randomized SCOT-HEART Trial. JAMA Cardiol. 2020 Jun 3. doi: 10.1001/jamacardio.2020.1567. [Epub ahead of print] Erratum in: JAMA Cardiol. 2020 Aug 1;5(8):968.
- Williams MC, Kwiecinski J, Doris M, McElhinney P, D'Souza MS, Cadet S, Adamson PD, Moss AJ, Alam S, Hunter A, Shah ASV, Mills NL, Pawade T, Wang C, Weir McCall J, Bonnici-Mallia M, Murrills C, Roditi G, van Beek EJR, Shaw LJ, Nicol ED, Berman DS, Slomka PJ, Newby DE, Dweck MR, Dey D. Low-Attenuation Noncalcified Plaque on Coronary Computed Tomography Angiography Predicts Myocardial Infarction: Results From the Multicenter SCOT-HEART Trial (Scottish Computed Tomography of the HEART). Circulation. 2020 May 5;141(18):1452-1462. doi: 10.1161/CIRCULATIONAHA.119.044720. Epub 2020 Mar 16.
- Adamson PD, Williams MC, Dweck MR, Mills NL, Boon NA, Daghem M, Bing R, Moss AJ, Mangion K, Flather M, Forbes J, Hunter A, Norrie J, Shah ASV, Timmis AD, van Beek EJR, Ahmadi AA, Leipsic J, Narula J, Newby DE, Roditi G, McAllister DA, Berry C; SCOT-HEART Investigators. Guiding Therapy by Coronary CT Angiography Improves Outcomes in Patients With Stable Chest Pain. J Am Coll Cardiol. 2019 Oct 22;74(16):2058-2070. doi: 10.1016/j.jacc.2019.07.085.
- Bing R, Henderson J, Hunter A, Williams MC, Moss AJ, Shah ASV, McAllister DA, Dweck MR, Newby DE, Mills NL, Adamson PD. Clinical determinants of plasma cardiac biomarkers in patients with stable chest pain. Heart. 2019 Nov;105(22):1748-1754. doi: 10.1136/heartjnl-2019-314892. Epub 2019 Jun 1.
- Williams MC, Moss AJ, Dweck M, Adamson PD, Alam S, Hunter A, Shah ASV, Pawade T, Weir-McCall JR, Roditi G, van Beek EJR, Newby DE, Nicol ED. Coronary Artery Plaque Characteristics Associated With Adverse Outcomes in the SCOT-HEART Study. J Am Coll Cardiol. 2019 Jan 29;73(3):291-301. doi: 10.1016/j.jacc.2018.10.066.
- SCOT-HEART Investigators, Newby DE, Adamson PD, Berry C, Boon NA, Dweck MR, Flather M, Forbes J, Hunter A, Lewis S, MacLean S, Mills NL, Norrie J, Roditi G, Shah ASV, Timmis AD, van Beek EJR, Williams MC. Coronary CT Angiography and 5-Year Risk of Myocardial Infarction. N Engl J Med. 2018 Sep 6;379(10):924-933. doi: 10.1056/NEJMoa1805971. Epub 2018 Aug 25.
- Adamson PD, Hunter A, Madsen DM, Shah ASV, McAllister DA, Pawade TA, Williams MC, Berry C, Boon NA, Flather M, Forbes J, McLean S, Roditi G, Timmis AD, van Beek EJR, Dweck MR, Mickley H, Mills NL, Newby DE. High-Sensitivity Cardiac Troponin I and the Diagnosis of Coronary Artery Disease in Patients With Suspected Angina Pectoris. Circ Cardiovasc Qual Outcomes. 2018 Feb;11(2):e004227. doi: 10.1161/CIRCOUTCOMES.117.004227.
- Adamson PD, Fordyce CB, McAllister DA, Udelson JE, Douglas PS, Newby DE. Identification of patients with stable chest pain deriving minimal value from coronary computed tomography angiography: An external validation of the PROMISE minimal-risk tool. Int J Cardiol. 2018 Feb 1;252:31-34. doi: 10.1016/j.ijcard.2017.09.033.
- Adamson PD, Hunter A, Williams MC, Shah ASV, McAllister DA, Pawade TA, Dweck MR, Mills NL, Berry C, Boon NA, Clark E, Flather M, Forbes J, McLean S, Roditi G, van Beek EJR, Timmis AD, Newby DE. Diagnostic and prognostic benefits of computed tomography coronary angiography using the 2016 National Institute for Health and Care Excellence guidance within a randomised trial. Heart. 2018 Feb;104(3):207-214. doi: 10.1136/heartjnl-2017-311508. Epub 2017 Aug 27.
- McCarter RV, McKay GJ, Quinn NB, Chakravarthy U, MacGillivray TJ, Robertson G, Pellegrini E, Trucco E, Williams MC, Peto T, Dhillon B, van Beek EJ, Newby DE, Kee F, Young IS, Hogg RE. Evaluation of coronary artery disease as a risk factor for reticular pseudodrusen. Br J Ophthalmol. 2018 Apr;102(4):483-489. doi: 10.1136/bjophthalmol-2017-310526. Epub 2017 Aug 19.
- Williams MC, Hunter A, Shah A, Assi V, Lewis S, Mangion K, Berry C, Boon NA, Clark E, Flather M, Forbes J, McLean S, Roditi G, van Beek EJ, Timmis AD, Newby DE; Scottish COmputed Tomography of the HEART (SCOT-HEART) Trial Investigators. Symptoms and quality of life in patients with suspected angina undergoing CT coronary angiography: a randomised controlled trial. Heart. 2017 Jul;103(13):995-1001. doi: 10.1136/heartjnl-2016-310129. Epub 2017 Feb 28.
- Williams MC, Hunter A, Shah ASV, Assi V, Lewis S, Smith J, Berry C, Boon NA, Clark E, Flather M, Forbes J, McLean S, Roditi G, van Beek EJR, Timmis AD, Newby DE; SCOT-HEART Investigators. Use of Coronary Computed Tomographic Angiography to Guide Management of Patients With Coronary Disease. J Am Coll Cardiol. 2016 Apr 19;67(15):1759-1768. doi: 10.1016/j.jacc.2016.02.026.
- Moss AJ, Newby DE. CT coronary angiographic evaluation of suspected anginal chest pain. Heart. 2016 Feb 15;102(4):263-8. doi: 10.1136/heartjnl-2015-307860. Epub 2015 Dec 8. Review.
- Williams MC, Golay SK, Hunter A, Weir-McCall JR, Mlynska L, Dweck MR, Uren NG, Reid JH, Lewis SC, Berry C, van Beek EJ, Roditi G, Newby DE, Mirsadraee S. Observer variability in the assessment of CT coronary angiography and coronary artery calcium score: substudy of the Scottish COmputed Tomography of the HEART (SCOT-HEART) trial. Open Heart. 2015 May 19;2(1):e000234. doi: 10.1136/openhrt-2014-000234. eCollection 2015.
- SCOT-HEART investigators. CT coronary angiography in patients with suspected angina due to coronary heart disease (SCOT-HEART): an open-label, parallel-group, multicentre trial. Lancet. 2015 Jun 13;385(9985):2383-91. doi: 10.1016/S0140-6736(15)60291-4. Epub 2015 Mar 15. Erratum in: Lancet. 2015 Jun 13;385(9985):2354.
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Completed
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4138
|
Same as current
|
May 2015
|
May 2015 (Final data collection date for primary outcome measure)
|
Inclusion Criteria:
- 18 and ≤75 years of age
- Attendance at the Rapid Access Chest Pain Clinic
Exclusion Criteria:
- Inability or unwilling to undergo computed tomography scanning, such as exceeding weight tolerance of scanner
- Severe renal failure (serum creatinine >200 µmol/L or estimated glomerular filtration rate <30 mL/min)
- Previous recruitment to the trial
- Major allergy to iodinated contrast agent
- Unable to give informed consent
- Known pregnancy
- Acute coronary syndrome within 3 months
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Sexes Eligible for Study: |
All |
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18 Years to 75 Years (Adult, Older Adult)
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No
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Contact information is only displayed when the study is recruiting subjects
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United Kingdom
|
|
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NCT01149590
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CZH/4/588
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No
|
Not Provided
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Plan to Share IPD: |
Undecided |
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University of Edinburgh
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University of Edinburgh
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- NHS Lothian
- Chief Scientist Office of the Scottish Government
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Principal Investigator: |
David E Newby, BA BSc BM DM PhD FRCP DSc |
University of Edinburgh |
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University of Edinburgh
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April 2017
|