Clinical trial NCT05725096: Role of Coronary CTA on Lipid Management and Risk Factors Control in an Asymptomatic Chinese Population
Official title: Role of the Screening with Coronary Computed Tomography Angiography on Lipid Management and Risk Factors Control in an Asymptomatic Chinese Population: a Community-based, Prospective Randomised Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Statin
Cardiovascular Risk Factors
Primary Prevention
Adherence, Medication
Lead sponsor: Jinling Hospital, China
Sponsor class: OTHER
First posted: 2023-02-13
Enrollment: 3400
Sex: ALL
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The proportion of participants taking lipid-lowering medication regularly at both 6 and 12 months
timeFrame: 12 months
Secondary outcomes:
measure: The proportion of participants achieving LDL-C targets at 12 months
timeFrame: 12 months
measure: The proportion of participants taking lipid-lowering medication regularly at 12 months.
timeFrame: 12 months
measure: Cardiovascular events
timeFrame: 12 months
measure: Prevalence of subclinical coronary atherosclerotic disease
timeFrame: baseline
measure: LDL-C levels
timeFrame: 12 months
measure: Hypertension control
timeFrame: 12 months
measure: Diabetic control
timeFrame: 12 months
measure: Smoking cessation
timeFrame: 12 months
measure: Exercise
timeFrame: 12 months
measure: Quality of life/Anxiety and Depression
timeFrame: 12 months
Other outcomes:
measure: Changes in renal function before and after CCTA examination
timeFrame: All participants in the experimental group completed CCTA 1 month later
Locations:
city: Nanjing
country: China
facility: Research Institute Of Medical Imaging Jinling Hospital
state: Jiangsu
Study officials:
affiliation: Jinling Hospital,Nanjing University School of Medicine,Nanjing,China
name: Trail Manager
role: STUDY_CHAIR
References: