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

Not Applicable

Recruiting

• Conditions: Cardiovascular Risk Factors; Statin; Adherence, Medication; Primary Prevention
• Interventions: Other: Traditional cardiovascular risk stratification; Diagnostic Test: Coronary Computed Tomography Angiography

• Registration Number: NCT05725096
• Lead Sponsor: Zhang longjiang,MD

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.

Study Timeline

• Study First Submitted: 2023-02-02
• Study First Submitted QC: 2023-02-02
• Study First Posted: 2023-02-13
• Study Start: 2023-06-28
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-03
• Study Completion: 2027-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 3400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Chinese guidelines for lipid management (2023)	Traditional cardiovascular risk stratification	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.
CCTA-based strategy group	Coronary Computed Tomography Angiography	Subjects will be managed following the CCTA -based coronary heart disease prevention strategy for lipid-lowering treatment and follow-up.

Primary Outcome Measures

Name	Time	Method
The proportion of participants taking lipid-lowering medication regularly at both 6 and 12 months	12 months	Taking lipid-lowering medication regularly defined as taking the established lipid-lowering medication (including statin, ezetimibe, xuezhikang and PCSK9 inhibitor) at least 24 days during the past 30 days.

Secondary Outcome Measures

Name	Time	Method
The proportion of participants achieving LDL-C targets at 12 months	12 months	The LDL-C treatment goals are made according to Chinese guideline
The proportion of participants taking lipid-lowering medication regularly at 12 months.	12 months	The proportion of participants taking lipid-lowering medication regularly at 12 months. Taking lipid-lowering medication regularly defined as taking the established lipid-lowering medication (including statin, ezetimibe, xuezhikang and PCSK9 inhibitor) at least 24 days during the past 30 days.
Cardiovascular events	12 months	Number of participants diagnosed with coronary heart disease, stroke (hemorrhagic and ischemic), TIA or cardiovascular death
Prevalence of subclinical coronary atherosclerotic disease	baseline	Proportion of subjects with coronary atherosclerosis in participants who underwent coronary CTA scan (%)
LDL-C levels	12 months	Compare the difference in LDL-C concentration between baseline and one year later, with the measurement unit being mmol/L.
Hypertension control	12 months	SBP\<140mmHg and DBP\<90mmHg
Diabetic control	12 months	HbA1c \<53 mmol/mol (7.0%)
Smoking cessation	12 months	Proportion of subjects who changed smoking habits (%)
Exercise	12 months	Change in activity levels measured through international physical activity questionnaire
Quality of life/Anxiety and Depression	12 months	Change in quality of life measured through PHQ-9 (patient health questionnaire): anxiety and depression score (%)

Trial Locations

Locations (1)

Research Institute Of Medical Imaging Jinling Hospital; 🇨🇳 Nanjing, Jiangsu, China