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

Official title

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

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.

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 test Coronary Computed Tomography Angiography
  Intervention strategies were selected according to CCTA results
• Other Standard Treatment
  Traditional cardiovascular disease prevention strategy based on Chinese guideline

Primary outcome measures

• The first occurrence of coronary heart disease [Time frame: 5 years]

Secondary outcome measures (12)

• Major cardiovascular adverse events (MACE) [Time frame: 5 years]
• Death [Time frame: 5 years]
• Occurrence of serious adverse events related to iodinated contrast agent [Time frame: 1 year]
• Coronary interventions [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 [Time frame: 5 years]
• Diet [Time frame: at 1-year follow-up and final follow-up (5 years)]
• Exercise [Time frame: at 1-year follow-up and final follow-up (5 years)]
• Smoking cessation [Time frame: at 1-year follow-up and final follow-up (5 years)]
• Change in cardiovascular risk factors (blood pressure) [Time frame: at 1-year follow-up and final follow-up (5 years)]
• Change in cardiovascular risk factors (lipids) [Time frame: at 1-year follow-up and final follow-up (5 years)]
• Change in cardiovascular risk factors (body weight) [Time frame: at 1-year follow-up and final follow-up (5 years)]
• Change in cardiovascular risk factors(waist circumference) [Time frame: at 1-year follow-up and final follow-up (5 years)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT05431309 · ZRui

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗