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

N/ANot Yet RecruitingNCT05431309

Jinling Hospital, China15,000 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Enrollment

Conditions

Cardiovascular Primary Prevention Strategy

Interventions

Coronary Computed Tomography AngiographyDIAGNOSTIC_TEST

Intervention strategies were selected according to CCTA results

Standard TreatmentOTHER

Traditional cardiovascular disease prevention strategy based on Chinese guideline

Eligibility

Sex: ALLMin age: 40 YearsMax age: 69 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

The first occurrence of coronary heart disease

Composite of cardiac death, myocardial infarction, angina, and an emergency/urgent coronary revascularisation procedure.

Time frame: 5 years

Secondary Outcomes

Major cardiovascular adverse events (MACE)

Number of cardiac death, myocardial infarction, emergency/urgent coronary revascularisation procedure and stroke

Time frame: 5 years

Death

Number of all-cause death, cardiovascular deaths, non-cardiovascular deaths and undetermined death

Time frame: 5 years

Occurrence of serious adverse events related to iodinated contrast agent

Composite outcome: contrast-induced nephropathy and severe allergoid contrast agent reaction

Time frame: 1 year

Coronary interventions

Number of invasive coronary angiography and coronary revascularisation procedures

Time frame: 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

Time frame: 5 years

Diet

Measured by Food Frequency Questionnaire

Central Contacts

Longjiang Zhang, MD

CONTACT

+8613405833176 kevinzhlj@163.com

Data from ClinicalTrials.gov

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