Coronary calcium scoring as first-line test to detect and exclude coronary artery disease in patients presenting to the general practitioner with stable chest pain: protocol of the cluster-randomised CONCRETE trial

• Published in: BMJ open 2022-04, Vol.12 (4), p.e055123
• Main Authors: Koopman, Moniek Y, Reijnders, Jorn J W, Willemsen, Robert T A, van Bruggen, Rykel, Doggen, Carine J M, Kietselaer, Bas, Oude Wolcherink, Martijn J, van Ooijen, Peter M A, Gratama, Jan Willem C, Braam, Richard, Oudkerk, Matthijs, van der Harst, Pim, Dinant, Geert-Jan, Vliegenthart, Rozemarijn
• Format: Article
• Language: English
• Subjects: Angina pectoris; Angina Pectoris - complications; Angina Pectoris - diagnosis; Calcification; Calcium; Cardiology; Cardiovascular disease; chest pain; Chest Pain - diagnosis; Chest Pain - etiology; computed tomography; Coronary Angiography - methods; coronary artery disease; Coronary Artery Disease - complications; Coronary Artery Disease - diagnosis; coronary calcium score; Coronary vessels; Electrocardiography; Family physicians; General Practitioners; Health care policy; Humans; Medical imaging; Medical referrals; Multicenter Studies as Topic; Objectives; Pain; Patients; Pragmatic Clinical Trials as Topic; Predictive Value of Tests; Primary care; Quality of Life; Radiology and Imaging; Randomized Controlled Trials as Topic; Vein & artery diseases; Womens health
• ISSN: 2044-6055; 2044-6055
• DOI: 10.1136/bmjopen-2021-055123

IntroductionIdentifying and excluding coronary artery disease (CAD) in patients with atypical angina pectoris (AP) and non-specific thoracic complaints is a challenge for general practitioners (GPs). A diagnostic and prognostic tool could help GPs in determining the likelihood of CAD and guide patient management. Studies in outpatient settings have shown that the CT-based coronary calcium score (CCS) has high accuracy for diagnosis and exclusion of CAD. However, the CT CCS test has not been tested in a primary care setting. In the COroNary Calcium scoring as fiRst-linE Test to dEtect and exclude coronary artery disease in GPs patients with stable chest pain (CONCRETE) study, the impact of direct access of GPs to CT CCS will be investigated. We hypothesise that this will allow for early diagnosis of CAD and treatment, more efficient referral to the cardiologist and a reduction of healthcare-related costs.Methods and analysisCONCRETE is a pragmatic multicentre trial with a cluster randomised design, in which direct GP access to the CT CCS test is compared with standard of care. In both arms, at least 40 GP offices, and circa 800 patients with atypical AP and non-specific thoracic complaints will be included. To determine the increase in detection and treatment rate of CAD in GP offices, the CVRM registration rate is derived from the GPs electronic registration system. Individual patients’ data regarding cardiovascular risk factors, expressed chest pain complaints, quality of life, downstream testing and CAD diagnosis will be collected through questionnaires and the electronic GP dossier.Ethics and disseminationCONCRETE has been approved by the Medical Ethical Committee of the University Medical Center of Groningen.Trial registration numberNTR 7475; Pre-results.