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 A1 - Newby,David E A1 - Williams,Michelle C A1 - Flappan,Andrew D A1 - Forbes,John F A1 - Hargreaves,Allister D A1 - Leslie,Stephen J A1 - Lewis,Steff C A1 - McKillop,Graham A1 - McLean,Scott A1 - Reid,John A1 - Spratt,James C A1 - Uren,Neal G A1 - van Beek,Edwin J A1 - Boon,Nicholas A A1 - Clark,Liz A1 - Craig,Peter A1 - Flather,Marcus D A1 - McCormack,Chiara A1 - Roditi,Giles A1 - Timmis,Adam D A1 - Krishan,Ashma A1 - Donaldson,Gillian A1 - Fotheringham,Marlene A1 - Hall,Fiona J A1 - Neary,Paul A1 - Cram,Louisa A1 - Perkins,Sarah A1 - Taylor,Fiona A1 - Eteiba,Hany A1 - Rae,Alan P A1 - Robb,Kate A1 - Barrie,Dawn A1 - Bissett,Kim A1 - Dawson,Adelle A1 - Dundas,Scot A1 - Fogarty,Yvonne A1 - Ramkumar,Prasad G A1 - Houston,Graeme J A1 - Letham,Deborah A1 - O'Neill,Linda A1 - Pringle,Stuart A1 - Ritchie,Valerie A1 - Sudarshan,Thiru A1 - Weir-McCall,Jonathan A1 - Cormack,Alistair A1 - Findlay,Iain N A1 - Hood,Stuart A1 - Murphy,Clare A1 - Peat,Eileen A1 - Allen,Barbara A1 - Bertram,Danielle A1 - Brian,David A1 - Cowan,Amy A1 - Cruden,Nicholas L A1 - Dweck,Marc R A1 - Flint,Laura A1 - Fyfe,Samantha A1 - Harding,Collette A1 - Macgillivray,Tom J A1 - Maclachlan,David S A1 - Macleod,Margaret A1 - Misadraee,Saeed A1 - Morrison,Avril A1 - Mills,Nicholas L A1 - Phillips,Alyson A1 - Queripel,Laura J A1 - Weir,Nicholas W A1 - Bett,Fiona A1 - Divers,Frances A1 - Fairley,Katie A1 - Jacob,Ashok J A1 - Keegan,Edith A1 - White,Tricia A1 - Gemmil,John A1 - Henry,Margo A1 - McGowan,James A1 - Dinnel,Lorraine A1 - Francis,Marc C A1 - Sandeman,Dennis A1 - Yerramasu,Ajay A1 - Berry,Colin A1 - Boylan,Heather A1 - Brown,Ammani A1 - Duffy,Karen A1 - Frood,Alison A1 - Johnstone,Janet A1 - Langhan,Kirsten A1 - Macduff,Ross A1 - Macleod,Martin A1 - McGlynn,Deborah A1 - McMillan,Nigel A1 - Murdoch,Laura A1 - Noble,Colin A1 - Paterson,Victoria A1 - Steedman,Tracey A1 - Tzemos,Nikolaos A1 - Baird,Andrew A1 - Minns,Fiona C 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,Steff C 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 - 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 - 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 M1 - Article JO - Trials JF - Trials VL - 13 ER -