Journal of Clinical Trials
Open Access
ISSN: 2167-0870
+44 1478 350008
ISSN: 2167-0870
+44 1478 350008
Carlijn M Van Der Aalst, Marleen Vonder, Jan-Willen Gratama, Henk J Adriaansen, Dirk Kuijpers, Sabine JAM Denissen, Pim Van Der Harst, Richard L Braam, Paul RM Van Dijkman, Rykel Van Bruggen, Frank W Beltman, Matthijs Oudkerk and Harry J de Koning
Objectives: This article aims to describe the rationale, study design, and the recruitment process of the Dutch Risk or Benefit in Screening for Cardiovascular Disease (ROBINSCA) trial, worldwide the first population-based randomized-controlled Computed-Tomography (CT) screening trial for cardiovascular disease, powered to detect a benefit of 15% reduced Coronary Heart Disease (CHD) morbidity and mortality.
Methods: Addresses of men (aged 45-74 years) and women (aged 55-74 years) were obtained (n=394,058) from the national population registry. All received a mailing with an information brochure, a questionnaire and waist measurement tape and an informed consent form. Asymptomatic people with an expected high-risk for developing CHD were included in this study: 1) a waist circumference of ≥ 102 cm (men) or ≥ 88 cm (women), 2) Body Mass Index of ≥ 30 kg/m2, 3) current smoker and/or 4) a family history of CHD. Eligible respondents were Randomized (1:1:1) to one of the study arms: intervention arm A (screening traditional risk factors), intervention arm B (screening by Coronary Artery Calcium scoring only) or the control arm (usual care). Screened participants with a high risk for developing CHD were referred to the general practitioner for cardiovascular risk management. Linkages with national registries will be performed to measure (CHD-related) morbidity and mortality.
Results: A total of 87,866 (22.3%) people responded to the questionnaire, of which 43,447 (49.4%) were Randomized to intervention arm A (n=14,478 (33.3%)), intervention arm B (n=14,450 (33.3%)), or the control arm (n=14,519 (33.4%)). Of those who were considered to be ineligible, one had prior diagnosis of CHD (n=14,156), a medication for hypercholesterolemia and hypertension (n=13,670), no completed informed consent (n=4,490), previous cardiovascular surgery (n=4,146), and/or a CAC score within the last 12 months (n=393).
Conclusion: Evidence for net-effectiveness of population-based screening for cardiovascular risk in an asymptomatic population will possibly enable large-scale implementation with large health gains.