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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCTA-based strategy group | Active Comparator | Subjects will be managed following the CCTA -based coronary heart disease prevention strategy for lipid-lowering treatment and follow-up. |
|
| Chinese guidelines for lipid management (2023) | Sham Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary Computed Tomography Angiography | Diagnostic Test | Intervention strategies according to CCTA results |
|
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants taking lipid-lowering medication regularly at both 6 and 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of participants achieving LDL-C targets at 12 months | The LDL-C treatment goals are made according to Chinese guideline | 12 months |
| The proportion of participants taking lipid-lowering medication regularly at 12 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in renal function before and after CCTA examination | The status of kidney function is represented by eGFR. | All participants in the experimental group completed CCTA 1 month later |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Longjiang Zhang, MD | Contact | 13405833167 | kevinzhlj@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Trail Manager | Jinling Hospital,Nanjing University School of Medicine,Nanjing,China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute Of Medical Imaging Jinling Hospital | Recruiting | Nanjing | Jiangsu | 210018 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39350195 | Derived | Guo X, Li J, Zhu Y, Li Y, Jiang J, Zuo R, Xu W, Ma J, Li C, Yang J, Liu Y, Zhao M, Tian D, Wang X, Sun J, Wu B, Wang C, Jiang P, Zhang J, Zhong J, Zhou C, Yi D, Bao X, Cai J, Chen Y, Cheng X, Gong H, Wei Y, Liu Y, Zhang LJ. Role of the screening with coronary computed tomography angiography on lipid management and risk factors control in an asymptomatic Chinese population: a community-based, parallel-group, open-label, randomized clinical trial (RESPECT2). Trials. 2024 Sep 30;25(1):635. doi: 10.1186/s13063-024-08469-z. |
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| Traditional cardiovascular risk stratification | Other | Intervention strategies according to traditional cardiovascular risk stratification based on Chinese guidelines for lipid management (2023) |
|
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.
| 12 months |
| Cardiovascular events | Number of participants diagnosed with coronary heart disease, stroke (hemorrhagic and ischemic), TIA or cardiovascular death | 12 months |
| Prevalence of subclinical coronary atherosclerotic disease | Proportion of subjects with coronary atherosclerosis in participants who underwent coronary CTA scan (%) | baseline |
| LDL-C levels | Compare the difference in LDL-C concentration between baseline and one year later, with the measurement unit being mmol/L. | 12 months |
| Hypertension control | SBP<140mmHg and DBP<90mmHg | 12 months |
| Diabetic control | HbA1c <53 mmol/mol (7.0%) | 12 months |
| Smoking cessation | Proportion of subjects who changed smoking habits (%) | 12 months |
| Exercise | Change in activity levels measured through international physical activity questionnaire | 12 months |
| Quality of life/Anxiety and Depression | Change in quality of life measured through PHQ-9 (patient health questionnaire): anxiety and depression score (%) | 12 months |
| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| ID | Term |
|---|---|
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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