Role of Coronary CTA on Lipid Management and Risk Factors Control in an Asymptomatic Chinese Population (RESPECT2)

Zhang longjiang,MD

Status: Enrolling

Conditions: Statin; Adherence, Medication; Primary Prevention; Cardiovascular Risk Factors

Treatments: Diagnostic Test: Coronary Computed Tomography Angiography; Other: Traditional cardiovascular risk stratification

Study type: Interventional

Funder types: Other

Identifiers

NCT05725096

2022DZKY-056-01

Details and patient eligibility

About

The primary objective of this study is to determine whether coronary computed tomography angiography (CCTA) -based coronary heart disease(CHD) prevention strategy improves lipid-lowering treatment and cardiovascular risk factor control compared with traditional CHD prevention strategy, guided by a cardiovascular risk score.

Full description

At present, doctors usually use a "risk score" to identify people at risk of heart disease who may benefit from medical treatment. In the RESPECT study the investigator will compare this "risk score" to coronary CTA scan. In this study the investigator would like to determine the effect of coronary CTA scan on lipid-lowering treatment and cardiovascular risk factor control.

This study will recruit 3400 eligible community volunteers (asymptomatic individuals free of any known cardiovascular event) aged 40 to 69 years, then, randomized (1:1) them to receive individualized primary prevention programs for coronary heart disease based on CCTA results or traditional risk score, as recommended in the Chinese CVD prevention guidelines. The intervention strategies in this study are consistent with RESPECT trial.

The investigator will assess the difference of lipid-lowering treatment and cardiovascular risk factor control between two groups 12 months later. Furthermore, the investigator will present the results of subclinical coronary atherosclerosis in participants who have undergone coronary CTA scans. This will help us understand the prevalence of subclinical coronary atherosclerotic disease in an asymptomatic Chinese population.

Enrollment: 3,400 estimated patients

Sex: All

Ages: 40 to 69 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Nanjing residents who have no plans to leave in the next 5 years
2. Aged from 40 to 69 years
3. Free of any known clinically cardiovascular disease Able to comprehend and sign an informed consent form

Exclusion criteria

1. Serious liver dysfunction, defined as AST or ALT > 3 times the normal upper limit
2. Chronic kidney disease (CKD) > stage 4, defined as eGFR < 30 ml/min/1.73 m2
3. Prior CCTA or invasive coronary angiography within the last 5 years
4. Any contraindications for CCTA
5. Previous use of statin or non-statin lipid-lowering medication (such as ezetimibe, PCSK9 inhibitor and XueZhiKang)
6. Life expectancy < 3 years
7. Other reasons the researcher deems inappropriate to attend

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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3,400 participants in 2 patient groups

CCTA-based strategy group

Active Comparator group

Description:

Subjects will be managed following the CCTA -based coronary heart disease prevention strategy for lipid-lowering treatment and follow-up.

Treatment:

Diagnostic Test: Coronary Computed Tomography Angiography

Chinese guidelines for lipid management (2023)

Sham Comparator group

Description:

The baseline assessment will be completed on the same day as consent is gained. Every subjects will complete a comprehensive assessment including questionnaires and objective assessments.

Treatment:

Other: Traditional cardiovascular risk stratification