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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• The first occurrence of coronary heart disease [Срок оценки: 5 years]

Вторичные конечные точки (12)

• Major cardiovascular adverse events (MACE) [Срок оценки: 5 years]
• Death [Срок оценки: 5 years]
• Occurrence of serious adverse events related to iodinated contrast agent [Срок оценки: 1 year]
• Coronary interventions [Срок оценки: 5 years]
• The primary end point(composite of cardiac death, myocardial infarction, angina, and an emergency/urgent coronary revascularisation procedure) in different subgroups [Срок оценки: 5 years]
• Diet [Срок оценки: at 1-year follow-up and final follow-up (5 years)]
• Exercise [Срок оценки: at 1-year follow-up and final follow-up (5 years)]
• Smoking cessation [Срок оценки: at 1-year follow-up and final follow-up (5 years)]
• Change in cardiovascular risk factors (blood pressure) [Срок оценки: at 1-year follow-up and final follow-up (5 years)]
• Change in cardiovascular risk factors (lipids) [Срок оценки: at 1-year follow-up and final follow-up (5 years)]
• Change in cardiovascular risk factors (body weight) [Срок оценки: at 1-year follow-up and final follow-up (5 years)]
• Change in cardiovascular risk factors(waist circumference) [Срок оценки: at 1-year follow-up and final follow-up (5 years)]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT05431309 · ZRui

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗