Adherence, Medication, Cardiovascular Risk Factors, Primary Prevention, Statin
Conditions
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.
Interventions
DIAGNOSTIC_TESTCoronary Computed Tomography Angiography
Intervention strategies according to CCTA results
OTHERTraditional cardiovascular risk stratification
Intervention strategies according to traditional cardiovascular risk stratification based on Chinese guidelines for lipid management (2023)
Sponsors
Zhang longjiang,MD
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 69 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 (%) |
| Hypertension control | 12 months | SBP\<140mmHg and DBP\<90mmHg |
Other
| Measure | Time frame | Description |
|---|---|---|
| Changes in renal function before and after CCTA examination | All participants in the experimental group completed CCTA 1 month later | The status of kidney function is represented by eGFR. |
Countries
China
Contacts
Primary ContactLongjiang Zhang, MD
Outcome results
None listed