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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.

SUBMITTER: Newby DE

PROVIDER: S-EPMC3667058 | biostudies-literature | 2012 Oct

REPOSITORIES: biostudies-literature

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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 DE Williams Michelle C MC Flapan Andrew D AD Forbes John F JF Hargreaves Allister D AD Leslie Stephen J SJ Lewis Steff C SC McKillop Graham G McLean Scott S Reid John H JH Sprat James C JC Uren Neal G NG van Beek Edwin J EJ Boon Nicholas A NA Clark Liz L Craig Peter P Flather Marcus D MD McCormack Chiara C Roditi Giles G Timmis Adam D AD Krishan Ashma A Donaldson Gillian G Fotheringham Marlene M Hall Fiona J FJ Neary Paul P Cram Louisa L Perkins Sarah S Taylor Fiona F Eteiba Hany H Rae Alan P AP Robb Kate K Barrie Dawn D Bissett Kim K Dawson Adelle A Dundas Scot S Fogarty Yvonne Y Ramkumar Prasad Guntur PG Houston Graeme J GJ Letham Deborah D O'Neill Linda L Pringle Stuart D SD Ritchie Valerie V Sudarshan Thiru T Weir-McCall Jonathan J Cormack Alistair A Findlay Iain N IN Hood Stuart S Murphy Clare C Peat Eileen E Allen Barbara B Baird Andrew A Bertram Danielle D Brian David D Cowan Amy A Cruden Nicholas L NL Dweck Marc R MR Flint Laura L Fyfe Samantha S Keanie Collette C MacGillivray Tom J TJ Maclachlan David S DS MacLeod Margaret M Mirsadraee Saeed S Morrison Avril A Mills Nicholas L NL Minns Fiona C FC Phillips Alyson A Queripel Laura J LJ Weir Nicholas W NW Bett Fiona F Divers Frances F Fairley Katie K Jacob Ashok J AJ Keegan Edith E White Tricia T Gemmill John J Henry Margo M McGowan James J Dinnel Lorraine L Francis C Mark CM Sandeman Dennis D Yerramasu Ajay A Berry Colin C Boylan Heather H Brown Ammani A Duffy Karen K Frood Alison A Johnstone Janet J Lanaghan Kirsten K MacDuff Ross R MacLeod Martin M McGlynn Deborah D McMillan Nigel N Murdoch Laura L Noble Colin C Paterson Victoria V Steedman Tracey T Tzemos Nikolaos N

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<h4>Background</h4>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 angiograp ...[more]

PMID: 23036114

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Project description:BackgroundThe future risk of myocardial infarction is commonly assessed using cardiovascular risk scores, coronary artery calcium score, or coronary artery stenosis severity. We assessed whether noncalcified low-attenuation plaque burden on coronary CT angiography (CCTA) might be a better predictor of the future risk of myocardial infarction.MethodsIn a post hoc analysis of a multicenter randomized controlled trial of CCTA in patients with stable chest pain, we investigated the association between the future risk of fatal or nonfatal myocardial infarction and low-attenuation plaque burden (% plaque to vessel volume), cardiovascular risk score, coronary artery calcium score or obstructive coronary artery stenoses.ResultsIn 1769 patients (56% male; 58±10 years) followed up for a median 4.7 (interquartile interval, 4.0-5.7) years, low-attenuation plaque burden correlated weakly with cardiovascular risk score (r=0.34; P<0.001), strongly with coronary artery calcium score (r=0.62; P<0.001), and very strongly with the severity of luminal coronary stenosis (area stenosis, r=0.83; P<0.001). Low-attenuation plaque burden (7.5% [4.8-9.2] versus 4.1% [0-6.8]; P<0.001), coronary artery calcium score (336 [62-1064] versus 19 [0-217] Agatston units; P<0.001), and the presence of obstructive coronary artery disease (54% versus 25%; P<0.001) were all higher in the 41 patients who had fatal or nonfatal myocardial infarction. Low-attenuation plaque burden was the strongest predictor of myocardial infarction (adjusted hazard ratio, 1.60 (95% CI, 1.10-2.34) per doubling; P=0.014), irrespective of cardiovascular risk score, coronary artery calcium score, or coronary artery area stenosis. Patients with low-attenuation plaque burden greater than 4% were nearly 5 times more likely to have subsequent myocardial infarction (hazard ratio, 4.65; 95% CI, 2.06-10.5; P<0.001).ConclusionsIn patients presenting with stable chest pain, low-attenuation plaque burden is the strongest predictor of fatal or nonfatal myocardial infarction. These findings challenge the current perception of the supremacy of current classical risk predictors for myocardial infarction, including stenosis severity. Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01149590.

Project description:ImportanceRecent European guidance supports a diminished role for exercise electrocardiography (ECG) in the assessment of suspected stable angina.ObjectiveTo evaluate the utility of exercise ECG in contemporary practice and assess the value of combined functional and anatomical testing.Design, setting, and participantsThis is a post hoc analysis of the Scottish Computed Tomography of the Heart (SCOT-HEART) open-label randomized clinical trial, conducted in 12 cardiology chest pain clinics across Scotland for patients with suspected angina secondary to coronary heart disease. Between November 18, 2010, and September 24, 2014, 4146 patients aged 18 to 75 years with stable angina underwent clinical evaluation and 1417 of 1651 (86%) underwent exercise ECG prior to randomization. Statistical analysis was conducted from October 10 to November 5, 2019.InterventionsPatients were randomized in a 1:1 ratio to receive standard care plus coronary computed tomography (CT) angiography or to receive standard care alone. The present analysis was limited to the 3283 patients who underwent exercise ECG alone or in combination with coronary CT angiography.Main outcomes and measuresThe primary clinical end point was death from coronary heart disease or nonfatal myocardial infarction at 5 years.ResultsAmong the 3283 patients (1889 men; median age, 57.0 years [interquartile range, 50.0-64.0 years]), exercise ECG had a sensitivity of 39% and a specificity of 91% for detecting any obstructive coronary artery disease in those who underwent subsequent invasive angiography. Abnormal results of exercise ECG were associated with a 14.47-fold (95% CI, 10.00-20.41; P < .001) increase in coronary revascularization at 1 year and a 2.57-fold (95% CI, 1.38-4.63; P < .001) increase in mortality from coronary heart disease death at 5 years or in cases of nonfatal myocardial infarction at 5 years. Compared with exercise ECG alone, results of coronary CT angiography had a stronger association with 5-year coronary heart disease death or nonfatal myocardial infarction (hazard ratio, 10.63; 95% CI, 2.32-48.70; P = .002). The greatest numerical difference in outcome with CT angiography compared with exercise ECG alone was observed for those with inconclusive results of exercise ECG (5 of 285 [2%] vs 13 of 283 [5%]), although this was not statistically significant (log-rank P = .05).Conclusions and relevanceThis study suggests that abnormal results of exercise ECG are associated with coronary revascularization and the future risk of adverse coronary events. However, coronary CT angiography more accurately detects coronary artery disease and is more strongly associated with future risk compared with exercise ECG.Trial registrationClinicalTrials.gov Identifier: NCT01149590.

Dataset Information

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.

Publications

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.

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