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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
14,980
Intensive intervention strategies based on the result of coronary computed tomography angiography
Comprehensive intervention strategies based on guidelines and expert consensus
DaQing Oilfield Hospital
Daqing, Heilongjiang, China
Daqing Longnan Hospital
Daqing, Heilongjiang, China
Heilongjiang Provincial Hospital, China
Harbin, Heilongjiang, China
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China
Beidahuang Industry Group General Hospital
Harbin, Heilongjiang, China
Hegang People Hospital
Hegang, Heilongjiang, China
The Baoquanling Hospital of Beidahuang Group
Hegang, Heilongjiang, China
Jiamusi Central Hospital
Jiamusi, Heilongjiang, China
The First Affiliated Hospital of Jiamusi University, China
Jiamusi, Heilongjiang, China
Hongqi Hospital Affiliated to Mudanjiang Medical University
Mudanjiang, Heilongjiang, China
...and 6 more locations
MACE
Time to first occurrence of any of the following: all-cause death, non-fatal myocardial infarction, or non-fatal stroke
Time frame: 18 months
All cause death
Number of cardiovascular and non-cardiovascular death
Time frame: 18 months
Myocardial infarction
Number of fatal and non-fatal myocardial infarction
Time frame: 18 months
Stroke
Number of fatal and non-fatal stroke
Time frame: 18 months
Hospitalization for chest pain
Number of hospitalization due to cardiac chest pain and hospitalization due to non-cardiac chest pain
Time frame: 18 months
Coronary revascularization
Number of percutaneous coronary intervention and coronary artery bypass grafting procedures
Time frame: 18 months
Invasive coronary angiography
Number of invasive coronary angiography
Time frame: 18 months
The proportion of antiplatelet drugs and lipid-lowering drugs used
The proportion of antiplatelet drugs and lipid-lowering drugs used
Time frame: Baseline and 1 month, 3 months, 6 months, 12 months, 18 months
Changes in lipid levels
Changes in TC, LDL-C, HDL-C, and TG
Time frame: Baseline and 18 months
Change in quality of life (EQ-5D-5L)
Change in quality of life measured using EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire: The first part is a descriptive system, assessing health in five dimensions. Each dimension has 5 levels from no problems to extreme problems (0-5), with higher scores for lower quality of life. The second part consists of a Visual Analogue Scale (VAS), assessing the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher quality of life.
Time frame: Baseline and 18 months
MACE at 36 months
Time to first occurrence of any of the following: all-cause death, non-fatal myocardial infarction, or non-fatal stroke
Time frame: 36 months
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