Key result
The RESPECT2 trial is an ongoing randomized clinical trial designed to evaluate whether a CCTA-guided strategy improves adherence to lipid-lowering medication compared to usual care in an asymptomatic population.
Why the study?
The accuracy and adherence of traditional cardiovascular risk stratification have been questioned, prompting investigation into whether CCTA-guided primary prevention improves management in asymptomatic individuals.
Does a CCTA-guided primary prevention strategy improve adherence to lipid-lowering medication compared to a traditional risk score-guided strategy in an asymptomatic community population?
RCT (n=3,400)
Open-label
1:1 ratio, stratified by CVD risk stratification
Does a CCTA-guided primary prevention strategy improve adherence to lipid-lowering medication compared to a traditional risk score-guided strategy in an asymptomatic community population?
This trial protocol outlines a study to determine whether visualizing coronary plaque with CCTA improves patient adherence to lipid-lowering therapy compared to traditional risk scoring in an asymptomatic population.
BACKGROUND: Lipid management based on cardiovascular risk level is the cornerstone of primary prevention of coronary artery disease (CAD), while the accuracy and adherence of traditional cardiovascular risk stratification have been questioned. Prevention strategies based on imaging screening for atherosclerotic plaques are found to be more objective and adherent in recent studies. This trial aims to investigate the role of coronary computed tomography angiography (CCTA) in guiding the primary prevention of CAD in a randomized controlled design. METHODS: Approximately 3400 middle-aged asymptomatic community participants will be recruited and randomized in a 1:1 ratio to a traditional cardiovascular risk score-guided (usual care group) or CCTA-guided (CCTA group) strategy. Participants with cardiovascular disease, prior lipid-lowering therapy, CCTA contraindication, or serious diseases that affect life span will be excluded. The intervention strategy includes blood pressure, blood glucose, and lipid management and lifestyle modifications. Blood pressure and glucose targets and lifestyle modification recommendations keep the same in both strategies, while lipid management is personalized based on traditional risk level or CCTA results, respectively. The primary outcome is the proportion of participants taking lipid-lowering medication regularly at both 6 and 12 months. The secondary outcomes include the proportion of participants achieving low-density lipoprotein cholesterol lowering targets at 12 months, mean changes in lipid levels from baseline to 12 months, barriers to adherence, adverse reactions related to CCTA examination, and cardiovascular events. DISCUSSION: The study is the first randomized clinical trial to examine the effectiveness of a CCTA-guided versus a traditional risk score-guided primary prevention strategy in an asymptomatic community-based population. TRIAL REGISTRATION: ClinicalTrials.gov NCT05725096. Registered on 2 February 2023.
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Guo et al. (2024) conducted an RCT in Primary prevention of coronary artery disease (n=3,400). CCTA-guided primary prevention strategy vs. Traditional cardiovascular risk score-guided strategy (usual care) was evaluated on Proportion of participants taking lipid-lowering medication regularly at both 6 and 12 months. The RESPECT2 trial is an ongoing randomized clinical trial designed to evaluate whether a CCTA-guided strategy improves adherence to lipid-lowering medication compared to usual care in an asymptomatic population.
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