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: Newby David E , Williams Michelle C , Flapan Andrew D , Forbes John F , Hargreaves Allister D , Leslie Stephen J , Lewis Steff C , McKillop Graham , McLean Scott , Reid John H , Sprat James C , Uren Neal G , van Beek Edwin J , Boon Nicholas A , Clark Liz , Craig Peter , Flather Marcus D , McCormack Chiara , Roditi Giles , Timmis Adam D , Krishan Ashma , Donaldson Gillian , Fotheringham Marlene , Hall Fiona J , Neary Paul , Cram Louisa , Perkins Sarah , Taylor Fiona , Eteiba Hany , Rae Alan P , Robb Kate , Barrie Dawn , Bissett Kim , Dawson Adelle , Dundas Scot , Fogarty Yvonne , Ramkumar Prasad Guntur , Houston Graeme J , Letham Deborah , O’Neill Linda , Pringle Stuart D , Ritchie Valerie , Sudarshan Thiru , Weir-McCall Jonathan , Cormack Alistair , Findlay Iain N , Hood Stuart , Murphy Clare , Peat Eileen , Allen Barbara , Baird Andrew , Bertram Danielle , Brian David , Cowan Amy , Cruden Nicholas L , Dweck Marc R , Flint Laura , Fyfe Samantha , Keanie Collette , MacGillivray Tom J , Maclachlan David S , MacLeod Margaret , Mirsadraee Saeed , Morrison Avril , Mills Nicholas L , Minns Fiona C , Phillips Alyson , Queripel Laura J , Weir Nicholas W , Bett Fiona , Divers Frances , Fairley Katie , Jacob Ashok J , Keegan Edith , White Tricia , Gemmill John , Henry Margo , McGowan James , Dinnel Lorraine , Francis C Mark , Sandeman Dennis , Yerramasu Ajay , Berry Colin , Boylan Heather , Brown Ammani , Duffy Karen , Frood Alison , Johnstone Janet , Lanaghan Kirsten , MacDuff Ross , MacLeod Martin , McGlynn Deborah , McMillan Nigel , Murdoch Laura , Noble Colin , Paterson Victoria , Steedman Tracey , Tzemos Nikolaos 
Published: October 2012

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