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. 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

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. 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. 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 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

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

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.

Original language	English
Article number	184
Pages (from-to)	184
Journal	Trials
Volume	13
DOIs	https://doi.org/10.1186/1745-6215-13-184
Publication status	Published - 4 Oct 2012
Externally published	Yes

Keywords

Computed tomography
Coronary heart disease
Rapid access chest pain clinic

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1186/1745-6215-13-184

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Newby, D. E., Williams, M. C., Flapan, A. D., Forbes, J. F., Hargreaves, A. D., Leslie, S. J., Lewis, S. C., McKillop, G., McLean, S., Reid, J. H., Sprat, J. C., Uren, N. G., van Beek, E. J., Boon, N. A., Clark, L., Craig, P., Flather, M. D., McCormack, C., Roditi, G., ... Tzemos, N. (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, 184. Article 184. https://doi.org/10.1186/1745-6215-13-184

@article{88013b86fa0c430585e3c15408da9988,

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 = "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",

author = "Newby, {David E.} and Williams, {Michelle C.} and Flapan, {Andrew D.} and Forbes, {John F.} and Hargreaves, {Allister D.} and Leslie, {Stephen J.} and Lewis, {Steff C.} and Graham McKillop and Scott McLean and Reid, {John H.} and Sprat, {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 Guntur} and Houston, {Graeme J.} and Deborah Letham and Linda O'Neill and Pringle, {Stuart D.} 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 Andrew Baird 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 Keanie and MacGillivray, {Tom J.} and Maclachlan, {David S.} and Margaret MacLeod and Saeed Mirsadraee and Avril Morrison and Mills, {Nicholas L.} and Minns, {Fiona C.} 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 Gemmill and Margo Henry and James McGowan and Lorraine Dinnel and Francis, {C. Mark} and Dennis Sandeman and Ajay Yerramasu and Colin Berry and Heather Boylan and Ammani Brown and Karen Duffy and Alison Frood and Janet Johnstone and Kirsten Lanaghan and Ross MacDuff and Martin MacLeod and Deborah McGlynn and Nigel McMillan and Laura Murdoch and Colin Noble and Victoria Paterson and Tracey Steedman and Nikolaos Tzemos",

year = "2012",

month = oct,

day = "4",

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

language = "English",

volume = "13",

pages = "184",

journal = "Trials",

issn = "1745-6215",

}

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 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, 184, pp. 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.; Flapan, Andrew D. et al.
In: Trials, Vol. 13, 184, 04.10.2012, p. 184.

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 - Flapan, Andrew D.

AU - Forbes, John F.

AU - Hargreaves, Allister D.

AU - Leslie, Stephen J.

AU - Lewis, Steff C.

AU - McKillop, Graham

AU - McLean, Scott

AU - Reid, John H.

AU - Sprat, 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 Guntur

AU - Houston, Graeme J.

AU - Letham, Deborah

AU - O'Neill, Linda

AU - Pringle, Stuart D.

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 - Baird, Andrew

AU - Bertram, Danielle

AU - Brian, David

AU - Cowan, Amy

AU - Cruden, Nicholas L.

AU - Dweck, Marc R.

AU - Flint, Laura

AU - Fyfe, Samantha

AU - Keanie, Collette

AU - MacGillivray, Tom J.

AU - Maclachlan, David S.

AU - MacLeod, Margaret

AU - Mirsadraee, Saeed

AU - Morrison, Avril

AU - Mills, Nicholas L.

AU - Minns, Fiona C.

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 - Gemmill, John

AU - Henry, Margo

AU - McGowan, James

AU - Dinnel, Lorraine

AU - Francis, C. Mark

AU - Sandeman, Dennis

AU - Yerramasu, Ajay

AU - Berry, Colin

AU - Boylan, Heather

AU - Brown, Ammani

AU - Duffy, Karen

AU - Frood, Alison

AU - Johnstone, Janet

AU - Lanaghan, Kirsten

AU - MacDuff, Ross

AU - MacLeod, Martin

AU - McGlynn, Deborah

AU - McMillan, Nigel

AU - Murdoch, Laura

AU - Noble, Colin

AU - Paterson, Victoria

AU - Steedman, Tracey

AU - Tzemos, Nikolaos

PY - 2012/10/4

Y1 - 2012/10/4

N2 - 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.

AB - 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.

KW - Computed tomography

KW - Coronary heart disease

KW - Rapid access chest pain clinic

UR - http://www.scopus.com/inward/record.url?scp=84866931099&partnerID=8YFLogxK

U2 - 10.1186/1745-6215-13-184

DO - 10.1186/1745-6215-13-184

M3 - Article

C2 - 23036114

AN - SCOPUS:84866931099

SN - 1745-6215

VL - 13

SP - 184

JO - Trials

JF - Trials

M1 - 184

ER -

Newby DE, Williams MC, Flapan 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;13:184. 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

Abstract

Keywords

UN SDGs

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