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Published in: Trials 1/2012

Open Access 01-12-2012 | 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

Authors: David E Newby, 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

Published in: Trials | Issue 1/2012

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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
Appendix
Available only for authorised users
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Metadata
Title
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
Authors
David E Newby
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
Publication date
01-12-2012
Publisher
BioMed Central
Published in
Trials / Issue 1/2012
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/1745-6215-13-184

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