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

BackgroundRapid 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.DiscussionThis 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

Standardized reporting systems for computed tomography coronary angiography and calcium scoring: A real-world validation of CAD-RADS and CAC-DRS in patients with stable chest pain

“…The SCOT-HEART trial was a multicenter randomized controlled trial investigating the use of CCTA in patients with suspected angina due to coronary artery disease. 3 The primary results of the SCOT-HEART study have been published previously. 4-6…”

“…1,2 The Scottish COmputed Tomography of the HEART (SCOT-HEART) trial is a large prospective multi-center randomized controlled trial that assessed the use of CCTA in patients with suspected angina due to coronary heart disease. 3 It showed that management based on CCTA improves diagnostic certainty and reduced the rate of coronary heart disease death and non-fatal myocardial infarction. 4,5 This post-hoc analysis of the SCOT-HEART trial aimed to assess the distribution of CAD-RADS and CAC-DRS groups within the SCOT-HEART population and to assess subsequent clinical outcomes.…”

High-Sensitivity Cardiac Troponin I and the Diagnosis of Coronary Artery Disease in Patients With Suspected Angina Pectoris

“…The study design 14 and principal findings 15 have previously been reported. Briefly, participants were recruited from 12 cardiology chest pain clinics across Scotland, and those randomized to the intervention arm underwent CCTA imaging at 1 of 3 sites in addition to routine clinical assessment.…”

Symptoms and quality of life in patients with suspected angina undergoing CT coronary angiography: a randomised controlled trial

“…The study design has previously been described 4 and the primary findings published. 12 Participants Participants were recruited from a dedicated cardiology chest pain clinic where they were referred with suspected angina due to coronary heart disease.…”