Effect of the RESPECT Trial on Lipid-lowering Treatment and Cardiovascular Risk Factor Control

Study Overview
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Brief Summary
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This is a pilot-study of the Role of Screening With Coronary Computed Tomography Angiography in Primary Prevention of Coronary Heart Disease (RESPECT [NCT05431309]) trial. 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
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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.

Official Title
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Effect of the Screenning With Coronary Computed Tomography Angiography on Lipid-lowering Treatment and Cardiovascular Risk Factor Control in an Asymptomatic Chinese Population: a Community-based, Prospective Randomised Controlled Study

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

Intervention / Treatment
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* Diagnostic Test: Coronary Computed Tomography Angiography
* Other: No Intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Resident population aged 40-69 in Nanjing, China Exclusion Criteria: 1.Plan to leave Nanjing within 5 years or be unable to complete the follow-up work 2.Refuse to sign informed consent 3.Known atherosclerotic cardiovascular disease (eg. angina, coronary heart disease, stroke, transient ischemic attack, peripheral vascular disease) 4.Serious chronic kidney disease (eGFR< 30 ml/min/1.73 m2) 5.Serious liver disease or dysfunction (chronic active hepatitis and cirrhosis, or aspartate aminotransferase (AST) or alanine transaminase (ALT) > 3 times the upper limit of normal) 6.Prior coronary computed tomography angiography or invasive coronary angiography within the last 5 years 7.Not appropriate to be tested due to birth planning, allergies, acute thyroid storm, etc 8.Current use of lipid-lowering treatment (including statin and nonstatin drugs, such as ezetimibe, PCSK9 inhibitor, Xuezhikang,etc) 9.Patients with diseases that seriously affect the survival period, such as malignant tumors 10.Other conditions at the discretion of the research group

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CCTA-based strategy group<br>Subjects will be managed following the CCTA -based coronary heart disease prevention strategy for lipid-lowering treatment and follow-up. | Diagnostic Test: Coronary Computed Tomography Angiography<br>* Intervention strategies were selected according to CCTA results<br>|
| Sham Comparator: Chinese guidelines for lipid management (2023)<br>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. | Other: No Intervention<br>* Chinese guidelines for lipid management (2023)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported current use of lipid-lowering treatment | Self-reported current use of lipid-lowering treatment (including statin and nonstatin drugs, such as ezetimibe, PCSK9 inhibitor, Xuezhikang,etc) according to physician's recommendation (%) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of subclinical coronary atherosclerotic disease | Proportion of subjects with coronary atherosclerosis in participants who underwent coronary CTA scan (%) | baseline | 
| Tracking atherosclerosis over time | Changes in the degree of coronary artery stenosis will be observed by coronary CTA in participants with coronary atherosclerosis | baseline and 12 months later | 
| Cardiovascular events | Number of participants diagnosed with coronary heart disease, stroke (hemorrhagic and ischemic), TIA or cardiovascular death | 12 months | 
| lipid-lowering therapies adherence | including statin and nonstatin drugs, such as ezetimibe, PCSK9 inhibitor, Xuezhikang,etc | 3 months, 6 months, 9 months | 
| Lipid levels | including total cholesterol, LDL-C, HDL-C, triglycerides | 3 months, 6 months, 9 months, 12 months | 
| Hypertension control | SBP<140mmHg and DBP<90mmHg | 3 months, 6 months, 9 months, 12 months | 
| Diabetic control | HbA1c <53 mmol/mol (7.0%) | 3 months, 6 months, 9 months, 12 months | 
| Smoking cessation | Proportion of subjects who changed smoking habits (%) | 3 months, 6 months, 9 months, 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 |