A Coronary Computed Tomography Angiography-guided Intervention for High Risk Cardiovascular Disease Population in Rural China

Официальное название

A Coronary Computed Tomography Angiography-guided Intensive Intervention for Population at High Risk for Cardiovascular Disease in Rural China: a Cluster Randomized Controlled Trial

Обзор

The CARDIAC trial is a prospective, parallel, open-label cluster randomized trial that aims to determine the effectiveness of a coronary computed tomography angiography (CTA)-guided intensive intervention strategy, as compared with standard care, on reducing the incidence of major adverse events (MACE) at 18 months among high-risk cardiovascular populations in rural China. An extended observational follow-up at 36 months will be conducted to further evaluate the effect on long-term clinical outcomes.

Подробное описание

The CARDIAC trial aims to determine the effectiveness of a coronary CTA-guided intensive intervention strategy, as compared with standard care, on improving clinical outcomes among population at high risk for cardiovascular disease in rural China. This cluster randomized trial will be conducted in 428 rural villages in China. The study will recruit 35 individuals at high risk for cardiovascular disease from each village for a total of 14,980 participants. The participating villages will be randomly assigned to experimental group (CTA-guided group) and control group (standard care group) with 1:1 allocation. Study participants will be followed at 1, 3, 6, 12, and 18 months. The primary outcome is major adverse cardiovascular events (MACE, a composite of all-cause death, non-fatal myocardial infarction, and non-fatal stroke) at 18 months. In addition, an extended observational follow-up will be conducted at 36 months, to evaluate long-term outcomes (i.e., MACE).

Вмешательства

• Диагностический тест CTA-guided Intensive Intervention Strategy
  Intensive intervention strategies based on the result of coronary computed tomography angiography
• Другое Comprehensive Intervention Strategy
  Comprehensive intervention strategies based on guidelines and expert consensus

Первичные конечные точки

• MACE [Срок оценки: 18 months]

Вторичные конечные точки (10)

• All cause death [Срок оценки: 18 months]
• Myocardial infarction [Срок оценки: 18 months]
• Stroke [Срок оценки: 18 months]
• Hospitalization for chest pain [Срок оценки: 18 months]
• Coronary revascularization [Срок оценки: 18 months]
• Invasive coronary angiography [Срок оценки: 18 months]
• The proportion of antiplatelet drugs and lipid-lowering drugs used [Срок оценки: Baseline and 1 month, 3 months, 6 months, 12 months, 18 months]
• Changes in lipid levels [Срок оценки: Baseline and 18 months]
• Change in quality of life (EQ-5D-5L) [Срок оценки: Baseline and 18 months]
• MACE at 36 months [Срок оценки: 36 months]

Критерии участия

Критерии включения

Inclusion criteria of study villages:

• Administrative villages
• The village has no plans to merge with other villages within 3 years
• The village is at least 2 kilometers away from other participating villages
• The village has a sufficient number of study participants
• The village is able to cooperate with the implementation of the study

Inclusion criteria of study participants:

• Men or women aged between 40 and 75 years
• Live stably in the province where the study is conducted and no intention to migrate within next 3 years
• Not participating in other clinical trials
• Meet any of the following:

(1)Low-Density Lipoprotein Cholesterol (LDL-C) ≥ 4.9 mmol/L or Total Cholesterol (TC) ≥ 7.2 mmol/L (2)Diabetes mellitus (3)Chronic Kidney Disease (CKD) Stage 3-4: estimated Glomerular Filtration Rate (eGFR) 15-59 mL/min/1.73m\^2 (4)With a history of hypertension and 3 risk factors, combined with LDL-C ≥ 1.8 mmol/L or TC ≥ 3.1 mmol/L \[Risk factors (assessed pre-intervention): smoking, low HDL-C, male ≥ 45 years old or female ≥ 55 years old\] (5)With a history of hypertension and 2 risk factors, combined with LDL-C ≥ 2.6 mmol/L or TC ≥ 4.1 mmol/L \[Risk factors (assessed pre-intervention): smoking, low HDL-C, male ≥ 45 years old or female ≥ 55 years old\] 5. Sign the informed consent

Критерии исключения

• Unwillingness or inability to undergo coronary CTA examination (e.g., previous history of severe contrast allergy, claustrophobia, or inability to cooperate with scanning and breath-holding for physical reasons in study participants)
• Typical angina symptoms, known coronary artery disease, or other major atherosclerotic cardiovascular disease
• Known cerebrovascular disease (e.g., cerebral hemorrhage, cerebral infarction, etc. )
• Prior invasive or non-invasive coronary angiography within the last 5 years
• Known familial hypercholesterolemia or other inherited disorders of lipid metabolism requiring lipid-lowering therapy
• Presence of active bleeding or diseases with a very high risk of bleeding (e.g., active peptic ulcer disease, gastrointestinal pathologies with increased risk of bleeding, hematologic disorders with increased risk of bleeding, etc.)
• End-stage diseases such as cirrhosis decompensation, with life expectancy <3 years
• Have a malignant tumor
• Intolerance of all statins
• Lipid-lowering treatment for >2 years
• Pregnant or breastfeeding, planning to become pregnant within the next 3 years
• eGFR <30 mL/min/1.73m\^2
• Platelet count <100×10\^9/L
• Poor compliance, unable to cooperate with study investigators
• Investigators consider unsuitable for participants selected for this study

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

Открытое

Основная цель

Профилактика

Центры проведения

Китай · 16 центров

• DaQing Oilfield Hospital — Daqing
• Daqing Longnan Hospital — Daqing
• Heilongjiang Provincial Hospital, China — Харбин
• The Second Affiliated Hospital of Harbin Medical University — Харбин
• Beidahuang Industry Group General Hospital — Харбин
• Hegang People Hospital — Hegang
• The Baoquanling Hospital of Beidahuang Group — Hegang
• Jiamusi Central Hospital — Jiamusi
• … и ещё 8 центров

Идентификаторы

NCT: NCT07416344 · 2024ZD0537902

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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