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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

3400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-28

Study Completion Date

2027-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Statin Cardiovascular Risk Factors Primary Prevention Adherence, Medication

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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CCTA-based strategy group

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

Group Type ACTIVE_COMPARATOR

Coronary Computed Tomography Angiography

Intervention Type DIAGNOSTIC_TEST

Intervention strategies according to CCTA results

Chinese guidelines for lipid management (2023)

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.

Group Type SHAM_COMPARATOR

Traditional cardiovascular risk stratification

Intervention Type OTHER

Intervention strategies according to traditional cardiovascular risk stratification based on Chinese guidelines for lipid management (2023)

Interventions

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Coronary Computed Tomography Angiography

Intervention strategies according to CCTA results

Intervention Type DIAGNOSTIC_TEST

Traditional cardiovascular risk stratification

Intervention strategies according to traditional cardiovascular risk stratification based on Chinese guidelines for lipid management (2023)

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

40 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No