The primary objective of this study is to evaluate whether a management strategy based on coronary computed tomography angiography (CCTA) for patients with non-obstructive coronary artery disease can improve the LDL-C target achievement rate compared to a traditional management strategy without follow-up CCTA, thereby reducing the incidence of major adverse cardiovascular and cerebrovascular events over a 3 years period, including all-cause mortality, myocardial infarction, ischemia driven revascularation and stroke.
Patients with non-obstructive coronary artery disease have a high rate of adverse cardiovascular events, and currently, there is still a lack of effective management strategies for these patients in clinical practice. In the SUCCESS study, investigator will compare follow-up CCTA management with routine clinical management to assess the effectiveness of follow-up CCTA in improving lipid control and reducing cardiovascular events in these patients. The SUCCESS study is a multicenter, randomized, parallel-controlled, interventional clinical trial that recruits patients with non-obstructive coronary artery disease identified on previous CCTA (coronary artery stenosis of 20% to 70% or left main coronary artery stenosis of 20% to 50%). The experimental group is the CCTA follow-up management group, and the control group is the routine clinical follow-up management group. All participants will be randomly assigned to the experimental and control groups in a 1:1 ratio. The experimental group will undergo management using follow-up CCTA, while the control group will be managed using routine clinical and laboratory examinations. At the 1-year follow-up, all participants will undergo laboratory re-examination to observe the impact of follow-up CCTA on lipid target achievement. After 3 years of follow-up, the differences in the occurrence of major adverse cardiovascular and cerebrovascular events (MACCE) between the two groups will be compared.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
3,100
Based on the assessment of plaque progression after follow-up CCTA examination, patients will be given either intensive treatment or routine treatment.
Patients will be treated according to the 2024 ESC Guidelines for the Management of Chronic Coronary Syndromes.
Research Institute Of Medical Imaging Jinling Hospital
Nanjing, Jiangsu, China
RECRUITINGMajor adverse cardiovascular and cerebrovascular event
Record the number of participants experiencing major adverse cardiovascular and cerebrovascular event such as all-cause mortality, non-fatal myocardial infarction, ischemia driven revascularation and stroke
Time frame: 36 months after baseline
LDL-C control rate
The proportion of participants with controlled LDL-C（\<1.4mmol/L）
Time frame: 12 months after baseline
Mean LDL-C changes
Mean LDL-C changes of participants
Time frame: 12 months after baseline
Adherence to lipid-lowering medication rate
The proportion of participants who adhere to lipid-lowering drugs
Time frame: 12 months after baseline
The difference in healthcare-seeking rates between the two groups
The difference in healthcare-seeking rates between the two groups of patients, including both regular follow-ups and visits driven by clinical symptoms of coronary heart disease
Time frame: 12 months after baseline
Hypertension control rate
The proportion of participants with SBP\<140mmHg and DBP\<90mmHg.
Time frame: 12 months after baseline
Diabetic control rate
The proportion of participants with HbA1c \<53 mmol/mol (7.0%).
Time frame: 12 months after baseline
Cardiac death
Number of participants diagnosed with cardiovascular death
Time frame: 36 months after baseline
Fatal and non-fatal myocardial infarction or stroke
Number of participants diagnosed with myocardial infarction or stroke
Time frame: 36 months after baseline
Rehospitalization due to progressive angina
Number of patients seeking medical care for unstable angina
Time frame: 36 months after baseline
Major adverse cardiovascular event
Record the number of participants experiencing major adverse cardiovascular events such as all-cause mortality, non-fatal myocardial infarction and ischemia driven revascularation
Time frame: 36 months after baseline
Procedures
The proportion of participants undergone procedures，including Invasive coronary angiography, percutaneous coronary intervention and coronary artery bypass graft surgery
Time frame: 36 months after baseline
Radiation dose and incidental findings from CTCA
The total radiation dose received by the participants during multiple examinations after enrollment.
Time frame: 36 months after baseline
Change in quality of life (SF-12)
Change in quality of life measured using 12-item Short-Form Health Survey Questionnaire (SF-12) instrument
Time frame: 36 months after baseline
The primary outcome in different subgroups
The primary outcome (all-cause mortality, non-fatal myocardial infarction, ischemia driven revascularation and stroke) will be analyzed in prespecified subgroups, including age, sex, hypertension, diabetes mellitus, degree of stenosis on baseline CCTA.
Time frame: 36 months after baseline
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