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Randomized Controlled Trial
. 2012 Oct 4:13:184.
doi: 10.1186/1745-6215-13-184.

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 Newby  1 , Michelle C Williams, Andrew D Flapan, John F Forbes, Allister D Hargreaves, Stephen J Leslie, Steff C Lewis, Graham McKillop, Scott McLean, John H Reid, James C Sprat, Neal G Uren, Edwin J van Beek, Nicholas A Boon, Liz Clark, Peter Craig, Marcus D Flather, Chiara McCormack, Giles Roditi, Adam D Timmis, Ashma Krishan, Gillian Donaldson, Marlene Fotheringham, Fiona J Hall, Paul Neary, Louisa Cram, Sarah Perkins, Fiona Taylor, Hany Eteiba, Alan P Rae, Kate Robb, Dawn Barrie, Kim Bissett, Adelle Dawson, Scot Dundas, Yvonne Fogarty, Prasad Guntur Ramkumar, Graeme J Houston, Deborah Letham, Linda O'Neill, Stuart D Pringle, Valerie Ritchie, Thiru Sudarshan, Jonathan Weir-McCall, Alistair Cormack, Iain N Findlay, Stuart Hood, Clare Murphy, Eileen Peat, Barbara Allen, Andrew Baird, Danielle Bertram, David Brian, Amy Cowan, Nicholas L Cruden, Marc R Dweck, Laura Flint, Samantha Fyfe, Collette Keanie, Tom J MacGillivray, David S Maclachlan, Margaret MacLeod, Saeed Mirsadraee, Avril Morrison, Nicholas L Mills, Fiona C Minns, Alyson Phillips, Laura J Queripel, Nicholas W Weir, Fiona Bett, Frances Divers, Katie Fairley, Ashok J Jacob, Edith Keegan, Tricia White, John Gemmill, Margo Henry, James McGowan, Lorraine Dinnel, C Mark Francis, Dennis Sandeman, Ajay Yerramasu, Colin Berry, Heather Boylan, Ammani Brown, Karen Duffy, Alison Frood, Janet Johnstone, Kirsten Lanaghan, Ross MacDuff, Martin MacLeod, Deborah McGlynn, Nigel McMillan, Laura Murdoch, Colin Noble, Victoria Paterson, Tracey Steedman, Nikolaos Tzemos
Affiliations
Randomized Controlled Trial

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 Newby et al. Trials. .

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.

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Figures

Figure 1
Figure 1
Rapid access chest pain clinic attendance, eligibility and recruitment. (CHD, coronary heart disease; CT, computed tomography; ECG, electrocardiogram; HDL, high dependency lipoprotein).
Figure 2
Figure 2
Computed tomography coronary angiography results and diagnosis documentation. (CHD, coronary heart disease; CT, computed tomography).
Figure 3
Figure 3
Plan of investigation (CHD, coronary heart disease; CT, computed tomography; CVD, cardiovascular disease).
See this image and copyright information in PMC

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