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January 1, 2019Journal of Clinical Trials

Risk or Benefit in Screening for Cardiovascular Disease (ROBINSCA): The Rationale and Study Design of a Population-Based Randomized-Controlled Screening Trial for Cardiovascular Disease

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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?

Population

43,447 asymptomatic high-risk men (45-74 years) and women (55-74 years)

Comparison

Traditional risk factor screening vs CAC scoring screening vs usual care

Design

Population-based randomized controlled trial

Key result

Population-based screening using traditional risk factors or coronary artery calcium scoring was initiated in 43,447 randomized asymptomatic high-risk individuals to assess CHD outcomes.

Authors

CACarlijn M. van der AalstMVMarleen VonderJGJ.W. Gratama

Discussion

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Overview

Initiates first large RCT of population CHD screening with CAC or risk factors; leaves clinical impact open pending outcome data.

Study Design

Type

RCT (n=43,447)

Randomization

1:1:1

Structured PICO

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?

P
Population
43,447 asymptomatic adults aged 45-74 years at high risk for developing coronary heart disease randomized to screening for traditional risk factors, coronary artery calcium scoring, or usual care.
I
Intervention
Screening for traditional risk factors (intervention arm A) or screening by Coronary Artery Calcium (CAC) scoring only (intervention arm B), with referral to general practitioner for cardiovascular risk management if high risk.
C
Comparator
Usual care (control arm).
O
Outcome
Coronary Heart Disease (CHD) morbidity and mortality.hard clinical

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.

Cite This Study

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. Population-based screening using traditional risk factors or coronary artery calcium scoring was initiated in 43,447 randomized asymptomatic high-risk individuals to assess CHD outcomes.

synapsesocial.com/papers/6aa404c5229fb590e7c621b9https://doi.org/10.4172/2167-0870.1000361
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