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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 will be superior to traditional CHD prevention strategy, in reducing the future risk of CHD which included myocardial infarction, angina, cardiac death, and an emergency/urgent coronary revascularisation procedure, in a community population aged 40 to 69 years with cardiovascular risk factors but no history of cardiovascular disease.
Recent studies found that the incidence of CAD, screening with CCTA, in the general population is as high as 42%~49%. However, the effectiveness of CCTA screening in the primary prevention of CHD is unclear. The investigators designed a randomized controlled, open-label, pragmatic study to determine whether coronary computed tomography angiography (CCTA) -based coronary heart disease(CHD) prevention strategy will be superior to traditional CHD prevention strategy.
Community volunteers aged 40 to 69 years who provide consent, and are eligible (with cardiovascular risk factors but no history of cardiovascular disease), will be randomized 1:1 to receive individualized primary prevention programs for CHD, including statin recommendation, based on CCTA results or traditional risk assessment results using the Chinese guideline on the primary prevention of cardiovascular diseases-recommended strategy. All subjects will be followed for 5 years, but until the target primary endpoint event is met. The primary composite outcome was the first occurrence of CHD, which included myocardial infarction, angina, cardiac death, and an emergency/urgent coronary revascularisation procedure.
In order to prepare the study with high quality, the investigators will performed a pilot study prior to the initiation of patient recruitment for the main study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CCTA-based strategy group | Active Comparator | Patients will be managed following the CCTA -based coronary heart disease prevention strategy for statin initiation and follow-up. |
|
| Traditional strategy group | Sham Comparator | Patients will be managed following the Traditional cardiovascular disease prevention strategy based on Chinese guideline for statin initiation and follow-up. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronary Computed Tomography Angiography | Diagnostic Test | Intervention strategies were selected according to CCTA results |
|
| Measure | Description | Time Frame |
|---|---|---|
| The first occurrence of coronary heart disease | Composite of cardiac death, myocardial infarction, angina, and an emergency/urgent coronary revascularisation procedure. | 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Major cardiovascular adverse events (MACE) | Number of cardiac death, myocardial infarction, emergency/urgent coronary revascularisation procedure and stroke | 5 years |
| Death | Number of all-cause death, cardiovascular deaths, non-cardiovascular deaths and undetermined death |
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Inclusion Criteria:
Resident population aged 40-69 in Nanjing, China
One or more of the following cardiovascular disease risk factors must be present, as follows:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Longjiang Zhang, MD | Contact | +8613405833176 | kevinzhlj@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Trial Manager | Jinling Hospital, Nanjing University School of Medicine, Nanjing, China. | Study Chair |
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| Standard Treatment | Other | Traditional cardiovascular disease prevention strategy based on Chinese guideline |
|
| 5 years |
| Occurrence of serious adverse events related to iodinated contrast agent | Composite outcome: contrast-induced nephropathy and severe allergoid contrast agent reaction | 1 year |
| Coronary interventions | Number of invasive coronary angiography and coronary revascularisation procedures | 5 years |
| The primary end point(composite of cardiac death, myocardial infarction, angina, and an emergency/urgent coronary revascularisation procedure) in different subgroups | The primary end point(composite of cardiac death, myocardial infarction, angina, and an emergency/urgent coronary revascularisation procedure) will be analyzed in prespecified subgroups, including age, sex, diabetes, smoking status, hypertension, diabetes mellitus, hyperlipidemia, Chronic kidney disease stage 3 | 5 years |
| Diet | Measured by Food Frequency Questionnaire | at 1-year follow-up and final follow-up (5 years) |
| Exercise | Change in activity levels measured through International Physical Activity Questionnaire(IPAQ) | at 1-year follow-up and final follow-up (5 years) |
| Smoking cessation | Proportion of patients who changed smoking habits (%) | at 1-year follow-up and final follow-up (5 years) |
| Change in cardiovascular risk factors (blood pressure) | Blood pressure(mmHg) | at 1-year follow-up and final follow-up (5 years) |
| Change in cardiovascular risk factors (lipids) | Lipids(mmol/L) | at 1-year follow-up and final follow-up (5 years) |
| Change in cardiovascular risk factors (body weight) | Body weight(kg) | at 1-year follow-up and final follow-up (5 years) |
| Change in cardiovascular risk factors(waist circumference) | Waist circumference(cm) | at 1-year follow-up and final follow-up (5 years) |
| Change in depression (PHQ-9) | Change in depression measured using Patient Health Questionnaire-9 (PHQ-9) instrument | at 1-year follow-up and final follow-up (5 years) |
| Change in anxiety (GAD-7) | Change in anxiety measured using Generalized Anxiety Disorder 7-item (GAD-7) instrument | at 1-year follow-up and final follow-up (5 years) |
| Change in quality of sleep(PSQI) | Change in quality of sleep measured using Pittsburgh Sleep Quality Index (PSQI) instrument | at 1-year follow-up and final follow-up (5 years) |
| Change in quality of life(SF-12) | Change in quality of quality of life measured using 12-item Short-Form Health Survey Questionnaire (SF-12) instrument | at 1-year follow-up and final follow-up (5 years) |
| Incidental findings in Computed Tomography Angiography group | Potential benefits and harms of the findings | at 1-year follow-up and final follow-up (5 years) |
| Medication adherence( anti-hypertension agent, hypoglycemic agent, antilipemic agents, anti-platelet, etc.) | Measure adherence using follow-up questionnaires (Whether participants are taking medication, why participants are not taking it or taking it, the name, frequency, dosage and side effects of the medication participants are taking) | at 1-year follow-up and final follow-up (5 years) |
| Health economics | Cost-Effectiveness analysis and Cost-Utility analysis | 5 years |
| Disadvantages of Radiation exposure | Radiation dose (mGy-cm) | 5 years |