Open Access Study protocol

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

David E Newby1, Michelle C Williams1*, Andrew D Flapan2, John F Forbes3, Allister D Hargreaves4, Stephen J Leslie5, Steff C Lewis6, Graham McKillop2, Scott McLean7, John H Reid8, James C Sprat4, Neal G Uren2, Edwin J van Beek9, Nicholas A Boon1, Liz Clark10, Peter Craig11, Marcus D Flather12, Chiara McCormack6, Giles Roditi1314, Adam D Timmis15, Ashma Krishan6, Gillian Donaldson8, Marlene Fotheringham8, Fiona J Hall8, Paul Neary8, Louisa Cram4, Sarah Perkins4, Fiona Taylor4, Hany Eteiba13, Alan P Rae13, Kate Robb13, Dawn Barrie16, Kim Bissett16, Adelle Dawson16, Scot Dundas16, Yvonne Fogarty16, Prasad Guntur Ramkumar16, Graeme J Houston16, Deborah Letham16, Linda O’Neill16, Stuart D Pringle16, Valerie Ritchie16, Thiru Sudarshan16, Jonathan Weir-McCall16, Alistair Cormack17, Iain N Findlay17, Stuart Hood17, Clare Murphy17, Eileen Peat17, Barbara Allen9, Andrew Baird9, Danielle Bertram9, David Brian9, Amy Cowan9, Nicholas L Cruden2, Marc R Dweck1, Laura Flint2, Samantha Fyfe9, Collette Keanie2, Tom J MacGillivray9, David S Maclachlan1, Margaret MacLeod2, Saeed Mirsadraee9, Avril Morrison182, Nicholas L Mills1, Fiona C Minns2, Alyson Phillips2, Laura J Queripel9, Nicholas W Weir29, Fiona Bett19, Frances Divers19, Katie Fairley19, Ashok J Jacob19, Edith Keegan19, Tricia White19, John Gemmill20, Margo Henry20, James McGowan20, Lorraine Dinnel21, C Mark Francis21, Dennis Sandeman21, Ajay Yerramasu21, Colin Berry14, Heather Boylan14, Ammani Brown14, Karen Duffy14, Alison Frood14, Janet Johnstone14, Kirsten Lanaghan14, Ross MacDuff14, Martin MacLeod14, Deborah McGlynn14, Nigel McMillan14, Laura Murdoch14, Colin Noble14, Victoria Paterson14, Tracey Steedman14 and Nikolaos Tzemos14

Author Affiliations

1 University of Edinburgh/BHF Centre for Cardiovascular Science, Chancellor’s Building, 49 Little France Crescent, Edinburgh, EH16 SU4, UK

2 Royal Infirmary of Edinburgh, 51 Little France Crescent, Edinburgh, EH16 4SA, UK

3 School of Economics, University of Edinburgh, 31 Buccleuch Place, Edinburgh, EH8 9JT, UK

4 Forth Valley Royal Hospital, Larbert, FK5 4WR, UK

5 Raigmore Hospital, Inverness, IV2 3UJ, UK

6 Edinburgh Clinical Trials Unit, University of Edinburgh, Western General Hospital, Crewe Road South, Edinburgh, EH4 2XU, UK

7 Barts Health NHS Trust, The Royal London Hospital, London, E1 1BB, UK

8 Borders General Hospital, Melrose, TD6 9BS, UK

9 Clinical Research Imaging Centre, University of Edinburgh, Queen’s Medical Research Institute, 47 Little France Crescent, Edinburgh, EH16 4TJ, UK

10 Peninsula Heart & Stroke Network, Plymouth, PL6 5QZ, UK

11 Chief Scientist Office, Scottish Government Health Directorates, St Andrew’s House, Edinburgh, EH1 3DG, UK

12 Royal Brompton Hospital, Sydney Street, London, SW3 6NP, UK

13 Glasgow Royal Infirmary, 16 Alexandra Parade, Glasgow, G31 2ER, UK

14 Western Infirmary, Glasgow/Institute of Cardiovascular & Medical Sciences, University of Glasgow, Glasgow, G12 8QQ, UK

15 London Chest Hospital, Bonner Road, London, E2 9JX, UK

16 Ninewells Hospital, Dundee, DD1 9SY, UK

17 Royal Alexandra Hospital, Paisley, PA2 9PN, UK

18 Western General Hospital, Edinburgh, EH4 2XU, UK

19 St John’s Hospital, Livingston, EH54 6PP, UK

20 University Hospital, Ayr, KA8 0RX, UK

21 Victoria Hospital, Kirkcaldy, KY2 5RA, UK

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Trials 2012, 13:184  doi:10.1186/1745-6215-13-184

Published: 4 October 2012

Abstract

Background

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 noninvasive computed tomography, which can be used to measure coronary artery calcium scores and perform coronary angiography in one examination. However, this technology has not been robustly evaluated in its application to the clinic.

Methods/design

The SCOT-HEART study is an open parallel group prospective multicentre randomized controlled trial of 4,138 patients attending the rapid access chest pain clinic for evaluation of suspected cardiac chest pain. Following clinical consultation, participants will be approached and randomized 1:1 to receive standard care or standard care plus ≥64-multidetector computed tomography coronary angiography and coronary calcium score. Randomization will be conducted using a web-based system to ensure allocation concealment and will incorporate minimization. The primary endpoint of the study will be the proportion of patients diagnosed with angina pectoris secondary to coronary heart disease at 6 weeks. Secondary endpoints will include the assessment of subsequent symptoms, diagnosis, investigation and treatment. In addition, long-term health outcomes, safety endpoints, such as radiation dose, and health economic endpoints will be assessed. Assuming a clinic rate of 27.0% for the diagnosis of angina pectoris due to coronary heart disease, we will need to recruit 2,069 patients per group to detect an absolute increase of 4.0% in the rate of diagnosis at 80% power and a two-sided P value of 0.05. The SCOT-HEART study is currently recruiting participants and expects to report in 2014.

Discussion

This is the first study to look at the implementation of computed tomography in the patient care pathway that is outcome focused. This study will have major implications for the management of patients with cardiovascular disease.

Trial registration

ClinicalTrials.gov Identifier: NCT01149590

Keywords:
Computed tomography; Coronary heart disease; Rapid access chest pain clinic