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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
3,400
Intervention strategies according to CCTA results
Intervention strategies according to traditional cardiovascular risk stratification based on Chinese guidelines for lipid management (2023)
Research Institute Of Medical Imaging Jinling Hospital
Nanjing, Jiangsu, China
RECRUITINGThe 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.
Time frame: 12 months
The proportion of participants achieving LDL-C targets at 12 months
The LDL-C treatment goals are made according to Chinese guideline
Time frame: 12 months
The proportion of participants taking lipid-lowering medication regularly at 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.
Time frame: 12 months
Cardiovascular events
Number of participants diagnosed with coronary heart disease, stroke (hemorrhagic and ischemic), TIA or cardiovascular death
Time frame: 12 months
Prevalence of subclinical coronary atherosclerotic disease
Proportion of subjects with coronary atherosclerosis in participants who underwent coronary CTA scan (%)
Time frame: baseline
LDL-C levels
Compare the difference in LDL-C concentration between baseline and one year later, with the measurement unit being mmol/L.
Time frame: 12 months
Hypertension control
SBP\<140mmHg and DBP\<90mmHg
Time frame: 12 months
Diabetic control
HbA1c \<53 mmol/mol (7.0%)
Time frame: 12 months
Smoking cessation
Proportion of subjects who changed smoking habits (%)
Time frame: 12 months
Exercise
Change in activity levels measured through international physical activity questionnaire
Time frame: 12 months
Quality of life/Anxiety and Depression
Change in quality of life measured through PHQ-9 (patient health questionnaire): anxiety and depression score (%)
Time frame: 12 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.