Cardiovascular Primary Prevention Strategy
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 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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTCoronary Computed Tomography Angiography
Intervention strategies were selected according to CCTA results
OTHERStandard Treatment
Traditional cardiovascular disease prevention strategy based on Chinese guideline
Sponsors
Jinling Hospital, China
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. Resident population aged 40-69 in Nanjing, China 2. One or more of the following cardiovascular disease risk factors must be present, as follows: 1. Current or recent (within 12 months) smoker 2. Clinical diagnosis of hypertension (\>140/90mmHg) 3. Hypercholesterolaemia (LDL≥4.1mmol/L or total cholesterol\>6.0 mmol/L, including familial hypercholesterolaemia) 4. Diabetes mellitus 5. Rheumatoid arthritis 6. Systemic lupus erythematosus 7. Family history of premature cardiovascular disease (first degree relative with atherosclerotic cardiovascular disease, males, age\<55 years; females, age\<60 years) 8. Chronic kidney disease stage 3 (eGFR 30\ 59mL/min/1.73 m2)
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 or inability to understand and comply with the program process 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 statin therapy 9. Patients with diseases that seriously affect the survival period, such as malignant tumors 10. Other conditions at the discretion of the research group
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The first occurrence of coronary heart disease | 5 years | Composite of cardiac death, myocardial infarction, angina, and an emergency/urgent coronary revascularisation procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Death | 5 years | Number of all-cause death, cardiovascular deaths, non-cardiovascular deaths and undetermined death |
| Occurrence of serious adverse events related to iodinated contrast agent | 1 year | Composite outcome: contrast-induced nephropathy and severe allergoid contrast agent reaction |
| Coronary interventions | 5 years | Number of invasive coronary angiography and coronary revascularisation procedures |
| The primary end point(composite of cardiac death, myocardial infarction, angina, and an emergency/urgent coronary revascularisation procedure) in different subgroups | 5 years | 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 |
| Diet | at 1-year follow-up and final follow-up (5 years) | Measured by Food Frequency Questionnaire |
| Exercise | at 1-year follow-up and final follow-up (5 years) | Change in activity levels measured through International Physical Activity Questionnaire(IPAQ) |
| Smoking cessation | at 1-year follow-up and final follow-up (5 years) | Proportion of patients who changed smoking habits (%) |
| Change in cardiovascular risk factors (blood pressure) | at 1-year follow-up and final follow-up (5 years) | Blood pressure(mmHg) |
| Change in cardiovascular risk factors (lipids) | at 1-year follow-up and final follow-up (5 years) | Lipids(mmol/L) |
| Major cardiovascular adverse events (MACE) | 5 years | Number of cardiac death, myocardial infarction, emergency/urgent coronary revascularisation procedure and stroke |
| Change in cardiovascular risk factors(waist circumference) | at 1-year follow-up and final follow-up (5 years) | Waist circumference(cm) |
| Change in depression (PHQ-9) | at 1-year follow-up and final follow-up (5 years) | Change in depression measured using Patient Health Questionnaire-9 (PHQ-9) instrument |
| Change in anxiety (GAD-7) | at 1-year follow-up and final follow-up (5 years) | Change in anxiety measured using Generalized Anxiety Disorder 7-item (GAD-7) instrument |
| Change in quality of sleep(PSQI) | at 1-year follow-up and final follow-up (5 years) | Change in quality of sleep measured using Pittsburgh Sleep Quality Index (PSQI) instrument |
| Change in quality of life(SF-12) | at 1-year follow-up and final follow-up (5 years) | Change in quality of quality of life measured using 12-item Short-Form Health Survey Questionnaire (SF-12) instrument |
| Incidental findings in Computed Tomography Angiography group | at 1-year follow-up and final follow-up (5 years) | Potential benefits and harms of the findings |
| Medication adherence( anti-hypertension agent, hypoglycemic agent, antilipemic agents, anti-platelet, etc.) | at 1-year follow-up and final follow-up (5 years) | 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) |
| Health economics | 5 years | Cost-Effectiveness analysis and Cost-Utility analysis |
| Disadvantages of Radiation exposure | 5 years | Radiation dose (mGy-cm) |
| Change in cardiovascular risk factors (body weight) | at 1-year follow-up and final follow-up (5 years) | Body weight(kg) |
Contacts
Primary ContactLongjiang Zhang, MD
Outcome results
None listed