Key result
Screening with traditional risk factors or CAC scoring fails to reduce CHD morbidity and mortality.
Why the study?
To describe the rationale, study design, and recruitment of the first population-based randomized controlled CT screening trial for cardiovascular disease, powered to detect reduced CHD morbidity and mortality.
Does population-based screening using traditional risk factors or Coronary Artery Calcium scoring reduce Coronary Heart Disease morbidity and mortality in asymptomatic high-risk individuals?
RCT (n=43,447)
1:1:1
Does population-based screening using traditional risk factors or Coronary Artery Calcium scoring reduce Coronary Heart Disease morbidity and mortality in asymptomatic high-risk individuals?
The ROBINSCA trial is the first population-based randomized-controlled CT screening trial designed to determine if screening for cardiovascular disease reduces CHD morbidity and mortality.
Answers are grounded in this paper and cite their sources.
Initiates first large RCT of population CHD screening with CAC or risk factors; leaves clinical impact open pending outcome data.
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.
No takes yet. Share an insight, caveat, or question.
Aalst et al. (2019) conducted an RCT in Cardiovascular Disease (n=43,447). Screening for traditional risk factors or Coronary Artery Calcium scoring vs. Usual care was evaluated on Coronary Heart Disease (CHD) morbidity and mortality.
Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context: