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; Michelle C Williams; Andrew D Flappan; John F Forbes; Allister D Hargreaves; Stephen J Leslie; Stephanie Lewis; Graham McKillop; Scott McLean; John Reid; James C Spratt; 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 G Ramkumar; Graeme J Houston; Deborah Letham; Linda O'Neill; Stuart Pringle; Valerie Ritchie; Thiru Sudarshan; Jonathan Weir-McCall; Alistair Cormack; Iain N Findlay; Stuart Hood; Clare Murphy; Eileen Peat; Barbara Allen; Danielle Bertram; David Brian; Amy Cowan; Nicholas L Cruden; Marc R Dweck; Laura Flint; Samantha Fyfe; Collette Harding; Tom J Macgillivray; David S Maclachlan; Margaret Macleod; Saeed Misadraee; Avril Morrison; Nicholas L Mills; Alyson Phillips; Laura J Queripel; Nicholas W Weir; Fiona Bett; Frances Divers; Katie Fairley; Ashok J Jacob; Edith Keegan; Tricia White; John Gemmil; Margo Henry; James McGowan; Lorraine Dinnel; Marc C Francis; Dennis Sandeman; Ajay Yerramasu; Avril Morrison; Colin Berry; Heather Boylan; Ammani Brown; Karen Duffy; Alison Frood; Janet Johnstone; Kirsten Langhan; Ross Macduff; Martin Macleod; Deborah McGlynn; Nigel McMillan; Laura Murdoch; Colin Noble; Victoria Paterson; Giles Roditi; Tracey Steedman; Nikolaos Tzemos; Andrew Baird; Fiona C Minns

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, Michelle C Williams, Andrew D Flappan, John F Forbes, Allister D Hargreaves, Stephen J Leslie, Stephanie Lewis, Graham McKillop, Scott McLean, John Reid, James C Spratt, Neal G Uren, Edwin J van Beek, Nicholas A Boon, Liz Clark, Peter Craig, Marcus D Flather, Chiara McCormack, Giles Roditi, Adam D TimmisAshma 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 G Ramkumar, Graeme J Houston, Deborah Letham, Linda O'Neill, Stuart Pringle, Valerie Ritchie, Thiru Sudarshan, Jonathan Weir-McCall, Alistair Cormack, Iain N Findlay, Stuart Hood, Clare Murphy, Eileen Peat, Barbara Allen, Danielle Bertram, David Brian, Amy Cowan, Nicholas L Cruden, Marc R Dweck, Laura Flint, Samantha Fyfe, Collette Harding, Tom J Macgillivray, David S Maclachlan, Margaret Macleod, Saeed Misadraee, Avril Morrison, Nicholas L Mills, Alyson Phillips, Laura J Queripel, Nicholas W Weir, Fiona Bett, Frances Divers, Katie Fairley, Ashok J Jacob, Edith Keegan, Tricia White, John Gemmil, Margo Henry, James McGowan, Lorraine Dinnel, Marc C Francis, Dennis Sandeman, Ajay Yerramasu, Avril Morrison, Colin Berry, Heather Boylan, Ammani Brown, Karen Duffy, Alison Frood, Janet Johnstone, Kirsten Langhan, Ross Macduff, Martin Macleod, Deborah McGlynn, Nigel McMillan, Laura Murdoch, Colin Noble, Victoria Paterson, Giles Roditi, Tracey Steedman, Nikolaos Tzemos, Andrew Baird, Fiona C Minns

Research output: Contribution to journal › Article › peer-review

Abstract / Description of output

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/designThe 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 registrationClinicalTrials.gov Identifier: NCT01149590.

Original language	English
Article number	184
Number of pages	13
Journal	Trials
Volume	13
Issue number	1
DOIs	https://doi.org/10.1186/1745-6215-13-184
Publication status	Published - 4 Oct 2012

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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
© 2012 Newby et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
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Newby, D. E., Williams, M. C., Flappan, A. D., Forbes, J. F., Hargreaves, A. D., Leslie, S. J., Lewis, S., McKillop, G., McLean, S., Reid, J., Spratt, J. C., Uren, N. G., van Beek, E. J., Boon, N. A., Clark, L., Craig, P., Flather, M. D., McCormack, C., Roditi, G., ... Minns, F. C. (2012). 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, 13(1), Article 184. https://doi.org/10.1186/1745-6215-13-184

@article{f88c6ac17fe34815b21ab71e05b42dc5,

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",

abstract = "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/designThe 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 registrationClinicalTrials.gov Identifier: NCT01149590.",

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

year = "2012",

month = oct,

day = "4",

doi = "10.1186/1745-6215-13-184",

language = "English",

volume = "13",

journal = "Trials",

publisher = "BMC",

number = "1",

}

Newby, DE , Williams, MC, Flappan, AD, Forbes, JF, Hargreaves, AD, Leslie, SJ, Lewis, S, McKillop, G, McLean, S, Reid, J, Spratt, 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, S, Ritchie, V, Sudarshan, T, Weir-McCall, J, Cormack, A, Findlay, IN, Hood, S, Murphy, C, Peat, E, Allen, B, Bertram, D, Brian, D, Cowan, A, Cruden, NL, Dweck, MR, Flint, L, Fyfe, S, Harding, C, Macgillivray, TJ, Maclachlan, DS, Macleod, M, Misadraee, S, Morrison, A, Mills, NL, Phillips, A, Queripel, LJ, Weir, NW, Bett, F, Divers, F, Fairley, K, Jacob, AJ, Keegan, E, White, T, Gemmil, J, Henry, M, McGowan, J, Dinnel, L, Francis, MC, Sandeman, D, Yerramasu, A, Morrison, A, Berry, C, Boylan, H, Brown, A, Duffy, K, Frood, A, Johnstone, J, Langhan, K, Macduff, R, Macleod, M, McGlynn, D, McMillan, N, Murdoch, L, Noble, C, Paterson, V, Roditi, G, Steedman, T, Tzemos, N, Baird, A & Minns, FC 2012, '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, vol. 13, no. 1, 184. https://doi.org/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. / Newby, David E ; Williams, Michelle C; Flappan, Andrew D et al.
In: Trials, Vol. 13, No. 1, 184, 04.10.2012.

Research output: Contribution to journal › Article › peer-review

TY - JOUR

T1 - 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

T2 - study protocol for randomized controlled trial

AU - Newby, David E

AU - Williams, Michelle C

AU - Flappan, Andrew D

AU - Forbes, John F

AU - Hargreaves, Allister D

AU - Leslie, Stephen J

AU - Lewis, Stephanie

AU - McKillop, Graham

AU - McLean, Scott

AU - Reid, John

AU - Spratt, James C

AU - Uren, Neal G

AU - van Beek, Edwin J

AU - Boon, Nicholas A

AU - Clark, Liz

AU - Craig, Peter

AU - Flather, Marcus D

AU - McCormack, Chiara

AU - Roditi, Giles

AU - Timmis, Adam D

AU - Krishan, Ashma

AU - Donaldson, Gillian

AU - Fotheringham, Marlene

AU - Hall, Fiona J

AU - Neary, Paul

AU - Cram, Louisa

AU - Perkins, Sarah

AU - Taylor, Fiona

AU - Eteiba, Hany

AU - Rae, Alan P

AU - Robb, Kate

AU - Barrie, Dawn

AU - Bissett, Kim

AU - Dawson, Adelle

AU - Dundas, Scot

AU - Fogarty, Yvonne

AU - Ramkumar, Prasad G

AU - Houston, Graeme J

AU - Letham, Deborah

AU - O'Neill, Linda

AU - Pringle, Stuart

AU - Ritchie, Valerie

AU - Sudarshan, Thiru

AU - Weir-McCall, Jonathan

AU - Cormack, Alistair

AU - Findlay, Iain N

AU - Hood, Stuart

AU - Murphy, Clare

AU - Peat, Eileen

AU - Allen, Barbara

AU - Bertram, Danielle

AU - Brian, David

AU - Cowan, Amy

AU - Cruden, Nicholas L

AU - Dweck, Marc R

AU - Flint, Laura

AU - Fyfe, Samantha

AU - Harding, Collette

AU - Macgillivray, Tom J

AU - Maclachlan, David S

AU - Macleod, Margaret

AU - Misadraee, Saeed

AU - Morrison, Avril

AU - Mills, Nicholas L

AU - Phillips, Alyson

AU - Queripel, Laura J

AU - Weir, Nicholas W

AU - Bett, Fiona

AU - Divers, Frances

AU - Fairley, Katie

AU - Jacob, Ashok J

AU - Keegan, Edith

AU - White, Tricia

AU - Gemmil, John

AU - Henry, Margo

AU - McGowan, James

AU - Dinnel, Lorraine

AU - Francis, Marc C

AU - Sandeman, Dennis

AU - Yerramasu, Ajay

AU - Morrison, Avril

AU - Berry, Colin

AU - Boylan, Heather

AU - Brown, Ammani

AU - Duffy, Karen

AU - Frood, Alison

AU - Johnstone, Janet

AU - Langhan, Kirsten

AU - Macduff, Ross

AU - Macleod, Martin

AU - McGlynn, Deborah

AU - McMillan, Nigel

AU - Murdoch, Laura

AU - Noble, Colin

AU - Paterson, Victoria

AU - Roditi, Giles

AU - Steedman, Tracey

AU - Tzemos, Nikolaos

AU - Baird, Andrew

AU - Minns, Fiona C

PY - 2012/10/4

Y1 - 2012/10/4

N2 - 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/designThe 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 registrationClinicalTrials.gov Identifier: NCT01149590.

AB - 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/designThe 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 registrationClinicalTrials.gov Identifier: NCT01149590.

U2 - 10.1186/1745-6215-13-184

DO - 10.1186/1745-6215-13-184

M3 - Article

C2 - 23036114

VL - 13

JO - Trials

JF - Trials

IS - 1

M1 - 184

ER -

Newby DE , Williams MC, Flappan AD, Forbes JF, Hargreaves AD, Leslie SJ et al. 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(1):184. doi: 10.1186/1745-6215-13-184