Role of Screening With Coronary Computed Tomography Angiography in Primary Prevention of Coronary Heart Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Role of Screening With Coronary Computed Tomography Angiography in Primary Prevention of Coronary Heart Disease: a Community-based, Prospective Randomised Controlled Study

Conditions
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Cardiovascular Primary Prevention Strategy

Intervention / Treatment
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* Diagnostic Test: Coronary Computed Tomography Angiography
* Other: Standard Treatment


Participation Criteria
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Eligibility Criteria
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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: Current or recent (within 12 months) smoker Clinical diagnosis of hypertension (>140/90mmHg) Hypercholesterolaemia (LDL≥4.1mmol/L or total cholesterol>6.0 mmol/L, including familial hypercholesterolaemia) Diabetes mellitus Rheumatoid arthritis Systemic lupus erythematosus Family history of premature cardiovascular disease (first degree relative with atherosclerotic cardiovascular disease, males, age<55 years; females, age<60 years) Chronic kidney disease stage 3 (eGFR 30 59mL/min/1.73 m2) Exclusion Criteria: Plan to leave Nanjing within 5 years or be unable to complete the follow-up work Refuse to sign informed consent or inability to understand and comply with the program process Known atherosclerotic cardiovascular disease (eg. angina, coronary heart disease, stroke, transient ischemic attack, peripheral vascular disease) Serious chronic kidney disease (eGFR< 30 ml/min/1.73 m2) 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) Prior coronary computed tomography angiography or invasive coronary angiography within the last 5 years Not appropriate to be tested due to birth planning, allergies, acute thyroid storm, etc Current use of statin therapy Patients with diseases that seriously affect the survival period, such as malignant tumors 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>Patients will be managed following the CCTA -based coronary heart disease prevention strategy for statin initiation and follow-up. | Diagnostic Test: Coronary Computed Tomography Angiography<br>* Intervention strategies were selected according to CCTA results<br>|
| Sham Comparator: Traditional strategy group<br>Patients will be managed following the Traditional cardiovascular disease prevention strategy based on Chinese guideline for statin initiation and follow-up. | Other: Standard Treatment<br>* Traditional cardiovascular disease prevention strategy based on Chinese guideline<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |