The RESPECT2 trial, a prospective, community-based, open-label, randomized controlled trial, is underway in Nanjing, China, to assess the impact of coronary computed tomography angiography (CCTA)-guided lipid management compared to usual care in asymptomatic individuals. This investigator-initiated trial aims to enroll 3400 participants aged 40 to 69 years to determine if CCTA screening improves lipid management and reduces cardiovascular risk.
Study Design and Objectives
The primary objective of the RESPECT2 trial is to evaluate the effect of a CCTA-guided prevention strategy on lipid management versus usual care in an asymptomatic population. A secondary objective is to determine the prevalence of subclinical coronary artery disease (CAD) among middle-aged and elderly individuals in Nanjing, China. Participants are randomized in a 1:1 ratio to either the CCTA group or the usual care group, stratified by cardiovascular disease (CVD) risk.
Eligibility and Randomization
Participants are recruited from community members across 11 municipal districts in Nanjing. Enrollment criteria include being asymptomatic and within the specified age range. Exclusion criteria include serious liver dysfunction or an eGFR < 30 ml/min/1.73 m2. Randomization is stratified by CVD risk (low, moderate, and high) according to Chinese guidelines for lipid management. The randomization sequence is generated using R software by an independent statistician.
Interventions and Treatments
In the usual care group, lipid-lowering strategies are developed based on CVD risk stratification per established guidelines. In the CCTA group, participants undergo CCTA, and lipid-lowering strategies are developed based on the presence or absence of coronary artery plaque. All participants receive cardiology clinic counseling. The LDL-C target values vary based on the group and CAD status, with stricter targets for those with CAD or higher risk profiles.
Follow-Up and Endpoints
Participants are followed up at 6 months (phone) and 12 months (in-person), with annual follow-ups planned for at least 5 years. The primary outcome is the proportion of participants taking lipid-lowering medication regularly at both 6 and 12 months, defined as taking medication at least 24 days during the past 30 days. Secondary outcomes include the proportion of participants achieving LDL-C targets at 12 months, changes in TC and LDL-C levels from baseline, and the occurrence of cardiovascular events.
Statistical Analysis
The primary analysis will be performed according to the intention-to-treat principle. A modified Poisson regression model will be used to estimate the risk ratio and 95% confidence interval (CI) associated with treatment effect. Subclinical CAD prevalence will be estimated using the Wald method. Two-sided P values less than 0.05 will indicate statistical significance.
Ethical Considerations
The study is conducted in accordance with the ethical principles of the Declaration of Helsinki and Good Clinical Practice. The study protocol and informed consent form have been approved by the institutional ethics committee. Data collected will be kept confidential and accessed only by the trial team.
